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Learning Zulu: A Secret History of Language in South Africa
Mark Sanders One of Choice's Outstanding Academic Titles for 2016
Longlisted for the 2017 Alan Paton Award for Non-Fiction, Sunday Times
The Infidel and the Professor: David Hume, Adam Smith, and the Friendship That Shaped Modern Thought
Dennis C. Rasmussen One of The Australian Review's 2017 Books of the Year
Selected for Bloomberg View's "Must-Reads of 2017: From Space to Chinese Noir"
One of Project Syndicate's Best Reads in 2017 (chosen by Kaushik Basu)
Shortlisted for the 2018 Ralph Waldo Emerson Award, Phi Beta Kappa Society
Thomas Aquinas's Summa theologiae: A Biography
Bernard McGinn Honorable Mention, 2015 Catholic Press Association Book Award, History Category
On the Move: Changing Mechanisms of Mexico-U.S. Migration
Filiz Garip Winner of the 2018 Mirra Komarovsky Book Award, Eastern Sociological Society
Co-Winner of the 2017 Best Book Award, Migration and Citizenship Section of the American Political Science Association
Winner of the 2017 Otis Dudley Duncan Award, Section on Population of the American Sociological Association
Honorable Mention for the 2019 ENMISA Distinguished Book Award, Ethnicity, Nationalism, and Migration Section the International Studies Association
Getting Tough: Welfare and Imprisonment in 1970s America
Julilly Kohler-Hausmann One of CHOICE's Outstanding Academic Titles for 2017
Honorable Mention for the 2018 Frederick Jackson Turner Award, Organization of American Historians
Chosen Nation: Mennonites and Germany in a Global Era
Benjamin W. Goossen Shortlisted for the 2018 European Studies Book Award, Council for European Studies
The Dead Sea Scrolls: A Biography
John J. Collins Winner of the 2013 Cover/Jacket Merit Award in the Professional, Scholarly Series category, New York Book Show
The World in a Book: Al-Nuwayri and the Islamic Encyclopedic Tradition
Elias Muhanna Winner of the Morris D. Forkosch Book Prize, Journal of the History of Ideas
Honorable Mention for the British-Kuwait Friendship Society Book Prize
The Code of Capital: How the Law Creates Wealth and Inequality
Katharina Pistor One of the Financial Times' Best Books of 2019: Economics
One of the Financial Times' Readers' Best Books of 2019
One of Business Insider's Richard Feloni's best books of 2019 on how we can rethink today's capitalism and improve the economy
The Dictionary Wars: The American Fight over the English Language
Peter Martin A Choice Outstanding Academic Title of the Year
The Lives of Bees: The Untold Story of the Honey Bee in the Wild
Thomas D. Seeley Finalist for the PROSE Award in Popular Science and Popular Mathematics, Association of American Publishers
Quaint, Exquisite: Victorian Aesthetics and the Idea of Japan
Grace E. Lavery Winner of the NAVSA Best Book of the Year, North American Victorian Studies Association


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COVID-19 /
One of the general characteristics of viruses is their genetic instability meaning that they prone to change from one generation to another, and newer and newer virus variants occur as a result of novel genetic mutations. The mutation rate of SARS-CoV-2 virus is slightly lower compared to that of other RNA-viruses, such as the influenza virus.
Some genetic mutations do not cause significant alterations in the viral characteristics. These variants are not registered epidemiologically, since the high incidence of mutations would make it impossible to follow all of them.
Genetic mutations in viruses might have an impact on:
pathogenicity, and transmission rate,
the symptoms and severity of the disease they cause
the duration of the infection and the disease course,
the diagnostic method that can detect the infection,
the efficacy of vaccination and medications.
In the following section, you can read a brief description on SARS-CoV-2 virus and its main variants, accounting for the COVID-19 pandemic.
Delta variant: Things you should know
The delta variant has been present worldwide and spreads at a higher rate than the original form and the previous variants of SARS-CoV-2.
The most important characteristics of the delta variant:
increased pathogenicity: its pathogenicity is more than twice as high compared to other variants, which means that an infected individual infects twice as much people (average of 6 people), as they did before in the earlier waves of COVID-19,
shorter incubation period (average of 4 days),
more severe symptoms: compared to other variants, there is a higher rate of hospitalizations (people who need hospital treatment) among the infected individuals (in the unvaccinated population),
differing symptoms: loss of taste and smell have become rare, while respiratory- and cold-like symptoms have become more common (headache, sore throat, runny nose, sneezing, subfebrility, fatigue, digestive problems, redness of the eye and increased tearing).
Another significant difference is that the fully vaccinated people tend to spread the delta variant easier, than other variants – although, the time of infection and while the infected individual carries and spreads the virus is shorter in the vaccinated population.
The currently available COVID-19 vaccines are effective against the delta variant, too. Vaccines do not protect against the infection itself, but they protect against developing a disease with more severe symptoms, and decrease the need for hospitalization and the number of deaths.
Omicron variant: things you should know
At the end of 2021, the omicron variant has been recorded in the most countries of the world, and the number of COVID-19 diseases spread by the omicron has also been on an increase. There are certain regions where the omicron is the dominant SARS-CoV-2 variant.
The most important characteristics of the omicron variant:
several mutations in the spike protein: several mutations are present in the omicron variant (the most important is within the genes coding the spike protein – among the 30 amino acids coding the spike protein, 15 have changed) – its exact effect on the vaccinated individuals is unkown yet, but data have been continuously collected and analyzed regarding this topic,
increased pathogenicity: the omicron variant's pathogenicity is 36% higher than that of the delta. One reason behind this phenomenon might be that as a result of the high mutation rate, this variant may break through acquired immunity more easily,
milder symptoms: the proportion of hospitalized individuals are lower compared that of with the delta variant (but the high number of infected individuals still accounts for a great burden on the health care system),
high risk for re-infections: the defense mechanisms of the immune system are likely to be less persistent.
The currently available COVID-19 vaccines are effective against the omicron variant, too. Vaccines do not protect against the infection itself, but they protect against developing a disease with more severe symptoms and decrease the need for hospitalization and the number of deaths.
The nomenclature of COVID-19 variants
The WHO uses simple, easy-to-remember and easy-to-pronounce names in the nomenclature of the genetic mutations of the COVID-19.
Since the virus continuously changes, the number of the newly occurring variants are untraceably high, thereby "common, public names" are only given to those variants of epidemiological importance. These names are used in public communication and in the different means of media in order to make communication plain and simple.
The original variant (code)names can be found in the following databases:
PANGO – The Pango nomenclature was established for the identification of the coronavirus variants of epidemiological importance. This database is less scientific, it is much more illustrative – the spread of the virus is visualized on maps.
GISAID (Global Initiative On Sharing Avian Influenza Data) – A scientific resource that enables open access to the genomic data of influenza viruses and coronaviruses that account for the COVID-19 pandemic. Currently millions of virus variants are listed in the database.
Nextstrain – This is a project with open source code, with which the genomic data of distinct pathogens can be analyzed. It organizes systematically the publicly available data and provides effective analytic and visualization tools for the public. Its purpose is to foster the understanding of the epidemiological importance of the viruses.
Scientific names are hard to pronounce and recall, and easy to miss. Therefore, naming the different virus variants based on their place of identification has become popular, but this nomenclature is stigmatizing. To avoid this, the WHO has come up with the idea of creating a nomenclature of phantasy names (currently the elements of the Greek alphabet are being used), and national authorities, the press and the citizens are also expected to use this nomenclature.
However, this nomenclature does not substitute the persisting scientific (code)names, since these names code for important scientific information as well, and they are used in research.
A detailed synthesis of the variants
Our purpose is to present the variants of global epidemiological importance, of which the following statements are true:
high pathogenicity,
the course of the disease caused by the virus has become more severe compared to that caused by the original variant (increase in number of deaths and number of hospitalizations),
the defense mechanisms of the acquired immune system (produced by vaccination or prior infection) is significantly weaker against the new variant,
decrease in efficacy of treatment or vaccination,
decrease in efficacy of diagnostic tools (the new variant cannot always be detected with the previous diagnostic tests).
WHO-name
PANGO-name
Place of identification
much faster
more severe
B.1.351
potentially faster
not more severe
Japan, Brazil
B.1.617.2
potentially more severe
B.1.1.529
South-Afrika
potentially
likely milder course
The emergence of novel virus variants with more dangerous features might lead to the introduction of new or stricter safety measures (mask wearing, organization and participation in music and dance events, curfew, etc. – the extent of the measures usually correlate with the potential threat the new variants pose on the population). Furthermore, the development of novel diagnostic methods, medical treatments or vaccines might be necessary as well.
There are several variants which are being tracked and are suspected to develop greater importance in the future.
Dangerous characteristic features include:
genetic mutations that potentially changes certain features of the virus (e.g., pathogenicity, the severity of the disease they cause, and the efficacy of the diagnostic methods and medical treatments),
their transmission is easier, or they develop multiple infection foci,
other epidemiological data suggest that the variant poses or will pose an epidemiological risk globally in the future.
These variants have been continuously monitored so that protective measures can be taken early. For further information on the symptoms of COVID-19 infection and the course of action in case of an infection, read the applicable articles:
General information on COVID-19 vaccines
Booster vaccination against COVID-19

redpajama_set_name: RedPajamaCommonCrawl


Why is it that you wrinkle your nose and squint when you see a dead rat on the road, but open your eyes, nose and mouth wide when you see a live one in your bedroom?
New research suggests common facial expressions like disgust and fear not only convey how you are feeling, but also alter your sensory relationship to the world around you. If eyes and mouth are open, when we experience fear, are we able to see any better? After a range of tests, researchers found that the open-mouthed expression allowed more of the world in.


Leif S. Peng is a Canadian cartoonist and illustrator who has created artwork for many corporate clients, including Nintendo. He has spent time as a researcher and writer of mid-20th century magazine artists, maintaining a popular internet blog called "Today's Inspiration", as well as teaching graphic design classes at Mohawk College in Hamilton, Ontario.
Leif studied art at Sheridan College in Brampton, Ontario. After graduation, he worked as a renderer at an advertising agency in Toronto. After the passing of a colleague named "Bud", Leif received a filing cabinet full of illustration clippings from The Saturday Evening Post, Esquire and other well-known magazines at the time. Over the years, Leif was often "pouring through Bud's files" for ideas and inspiration for his own illustrations. In the early 2000s, he decided to scan a 1950s pin-up girl illustration and email it to several friends, with the subject line "Today's Inspiration", which was met with much enthusiasm, and the email list grew over the next two years.
In 2005, Leif began his "Today's Inspiration" internet blog, which allowed him to annotate the posts with his own thoughts as well. As interest and popularity in the blog grew, Leif developed an interest in learning about the business and artists behind the mid-20th century classic magazine images. He began collecting his own magazine material, either sourcing them online or through second-hand bookstores. Leif has been contacted by "dozens" of family members of the artists of the illustrations, and sometimes even by the artists themselves. He has spent time researching, interviewing and writing about mid-20th century illustrators, even crowdfunding an artwork book showing the work of Ken Dallison, a prolific car and truck illustrator.
Other than blog posting and research, Leif has worked in promotional marketing and logo design for corporations such as Nestlé, school textbook illustrations for the Oxford University press, and children's book covers and interior illustrations for Nintendo and HarperCollins.
In 2007, Leif received the Award of Excellence in Illustration from the Society of News Design. From late 2009, Leif has been a professor and instructor in the graphic design program at Mohawk College in Hamilton, Ontario. His son, Simon, has also been involved in illustrating.
Artwork by Leif Peng, showing Mario holding an unlabelled bottle of Heinz Tomato Ketchup, and a Super Game Boy cartridge.
In the 1990s, Leif created an artwork for Nintendo which was used as a backing card for Heinz Tomato Ketchup, featuring Super Mario. He has also illustrated a Super Mario birthday card, licensed to the direct mail division of Leo Brunette.
Between 1994 and 1997, Leif contributed line illustrations to all three Donkey Kong Country children's books, which are published by Troll Communications and feature characters and similar plots from the Donkey Kong franchise of games. Leif later illustrated the step-by-step sketches seen in the How to Draw Donkey Kong & Friends book.
↑ About Leif Peng. Flickr. Retrieved February 13, 2017.
↑ Ken Dallison - A Life in Illustration Kickstarter. Retrieved February 13, 2017.
↑ About Leifdrawing101 Blogspot. Retrieved February 13, 2017.
↑ Comment posted at "Super Mario backer card art" by Leif Peng Flickr. Retrieved February 13, 2017.
This page was last edited on March 15, 2018, at 14:14.


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Provisional determination eligibility criteria
Including supporting documentation
Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination
The Therapeutic Goods Regulations were amended in July 2021 to support the timely availability of new COVID-19 vaccines and treatments.
See the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021.
Provisional determination applications for COVID-19 vaccines or treatments are not required to demonstrate comparison to other medicines that are registered in the Australian Register of Therapeutic Goods (ARTG), or justification of a major therapeutic advance (criteria 3 and 4). This is to facilitate potential availability of a range of COVID-19 vaccine and treatment options through the provisional registration pathway.
Standard data requirements apply for the safety, quality and efficacy of COVID-19 vaccines or treatments as part of the provisional registration application.
Sponsors of COVID-19 vaccines or treatments are encouraged to contact the TGA prior to making a provisional determination application (email streamlinedsubmission@health.gov.au).
This guidance helps sponsors to understand the eligibility criteria and supporting documentation required for a medicine to be eligible for provisional determination.
To assist with the process of applying for provisional determination, please see Provisional determination: A step-by-step guide for prescription medicines.
On this page: Eligibility for provisional determination | Provisional determination | Supporting documentation requirements | Addressing the criteria | Clinical study plan for provisional determination application
Eligibility for provisional determination
If you have not had a pre-submission meeting with TGA to discuss your prospective application for provisional determination, or if your pre-submission meeting was more than six months ago, you should notify TGA of your intent to lodge a provisional determination application at least one month prior to lodgement. Consider all of the eligibility criteria and supporting documentation before notifying us.
Provisional determination may be granted for the following medicines only:
a new prescription medicine which contains:
a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in the Australian Register of Therapeutic Goods (ARTG)
a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in the ARTG
an already registered prescription medicine with a new indication (a new indications medicine) that:
has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the ARTG
does not have the same indications as that other medicine
The Therapeutic Goods Regulations were amended in July 2021 for COVID-19 vaccines and treatments. Criteria #3 and #4 below are not required to be addressed in provisional determination applications for COVID-19 vaccines or treatments. See the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021.
A medicine may be eligible for provisional determination if all eligibility criteria in the table below are satisfied.
Eligibility criteria for provisional determination*
1. Medicine
a new indications medicine OR a new prescription medicine
2. Serious condition
an indication of the medicine is the treatment, prevention or diagnosis of a life threatening or seriously debilitating condition
3. Comparison against existing therapeutic goods
no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for provisionally registered goods)
if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods
4. Major therapeutic advance
there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance
5. Clinical study plan
the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years (starting on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine).
*regulation 10L Therapeutic Goods Regulations 1990
Provisional determination
The provisional determination for a medicine is specific to the following (section 22D(3) of the Act):
the person who is the provisional applicant
each active ingredient of the medicine to which the determination relates
the provisional indication
The provisional determination therefore applies to a specific medicine for a specific indication.
The indication proposed at determination may be different to that approved at the time of registration as a result of the assessment of the quality, safety and efficacy data submitted with the registration submission for provisional registration, but must be a related indication.
Provisional determination for one indication and one medicine
You can apply for only one indication and one medicine per determination application. If you are seeking determination for multiple indications or medicines, you must submit one application for each indication and/or medicine. A separate fee applies to each application.
Only one determination can apply to each registration application. A registration application that is a combination of provisional designated and any non-provisional indications will not be eligible for review under the Provisional pathway. You may lodge a separate submission where the scope of the submission is not covered by a provisional determination.
The determination will apply to the corresponding registration application for a new prescription medicine or new indications medicine.
You must apply for more than one determination if your product is for a combination treatment, but not a fixed dose combination
In vitro diagnostic device use
If your provisional determination application is supported by clinical trials where an in vitro diagnostic (IVD) medical device was used to select patients who should or should not be treated, or to monitor patients with the aim of improving the safety or efficacy of the medicine, it is important that you supply the following information:
specify the name of the IVD medical device and the name of the manufacturer of the device; and
indicate whether the IVD medical device is an in-house IVD medical device (this includes the use of products that are intended by the manufacturer as being for research use only); and
if the IVD medical device is included in the ARTG, provide the ARTG entry number and name of the sponsor; or
if aware, provide details on any current application for inclusion of the IVD medical device in the ARTG; or
if the IVD medical device is not included on the ARTG, we would appreciate an update on what steps the manufacturer of the medical device might be making to include the product in the register in Australia
Supporting documentation requirements
The main body of your application should be no more than 10 pages. Include additional supporting documentation as attachments.
Your application should include a cover letter and be based on preliminary clinical data that is promising evidence of efficacy and safety of the medicine.
The main body of the application should address:
justifications for addressing all eligibility criteria
justification of any early, or surrogate endpoint(s) used to demonstrate clinical benefit specific to the condition that is subject of the application
overseas regulatory status
Attachments should include:
sufficient evidence of a plan to submit comprehensive clinical data on the safety and efficacy of the medicine within the provisional registration timeframes and whether recruitment is completed, commenced, or not started for each study.
summaries of pivotal studies or appropriate study summary
summaries of any available other important safety data obtained in the preclinical and clinical setting
where published papers are highly relevant for the medicine, surrogate or early endpoint, the full text of such literature (including supplementary appendices)
other forms of literature references or unpublished reports and expert statements may also be used in addition to the pivotal study summaries but would be considered low-level evidence
an abbreviations list
Preliminary clinical data
The determination stage comes before the prescription medicine registration application (for further information refer to Provisional determination: A step-by-step guide for prescription medicines.
The determination application is based on preliminary data and a plan for comprehensive data that confirms predicted benefit and safety as early as possible in the provisional registration period.
Assessment of preliminary data could be based on:
a non-validated surrogate endpoint
a single arm study
a non-randomised comparison
an interim analysis/duration of study
a small database
recruitment from a narrow group of patients
Clinical data supporting provisional determination
For a provisional determination and subsequent provisional registration application, the clinical data available may be limited. For example, data on final outcomes such as morbidity and mortality may not be available yet and results may be based on surrogate endpoints that are reasonably likely to predict clinical benefit. The scientific evidence may therefore be less comprehensive than would typically be required, but needs to be adequate and convincing evidence based on clinical trials (usually randomised controlled trials).
We recommend that you support your application with justifications and as an appendix the pivotal clinical study synopses that would be included as part of the body of the clinical study reports intended to support the registration application. Also include a clinical study plan, including study protocols and top-line recruitment status. Where study synopses are not available, provide a summary of the study with detail comparable to a study synopsis. We do not require a full module 2 summary. Do not submit full study reports.
Where a surrogate endpoint is used it should be recognised to be reasonably likely to predict an effect on clinical outcomes that establish direct clinical benefit (for example morbidity and mortality). A surrogate endpoint does not need to be validated (i.e. be an endpoint that is known to predict clinical benefit and could be used for standard approval), but needs empirical evidence to support that it is reasonably likely to predict direct clinical benefit.
Submit a justification of the suitability of the surrogate endpoint with the application that considers:
the ability to predict benefit based on evidence
the strength of the evidence
the certainty of the prediction
why remaining uncertainties are considered acceptable
The appropriateness of a surrogate endpoint for provisional registration will be assessed in the determination application.Consideration will be given to evidence linking the surrogate endpoints to important clinical endpoints, and the clinical study plan that outlines the data that will likely be provided within the period of provisional registration. Whether an endpoint is reasonably likely to predict clinical benefit (i.e. the suitability of the endpoint) will be determined on a case by case basis. Appropriateness of a surrogate endpoint in one condition may not necessarily be appropriate for a different condition.
Choosing the most appropriate registration pathway
The use of a surrogate endpoint as a primary endpoint in a pivotal study of clinical efficacy/safety will not automatically require a registration application to be submitted through the Provisional pathway.
We will determine the appropriateness of a surrogate endpoint or early endpoint for provisional registration versus standard registration on a case-by-case basis. In the case of medicines treating rare diseases where the collection of comprehensive confirmatory data for submission at a later time may not be possible, the standard registration pathway may be more appropriate than the provisional registration pathway. These medicines would not be eligible for the provisional registration pathway if you are unable to demonstrate that you have a plan to collect comprehensive clinical data on the safety and efficacy of the medicine before the end of the provisional registration period.
We strongly encourage you to arrange a pre-submission meeting with TGA prior to lodging your determination application and include this as part of the agenda.
Addressing the criteria
We will determine the validity of your justifications against the eligibility criteria on a case-by-case basis. As part of the routine determination process, the extent to which criteria are met will be assessed at the time a decision is made on the application.
Criterion 1: New indications medicine or new prescription medicine
Only certain types of medicines are eligible for provisional determination. The medicine must either be a new indications medicine or a new prescription medicine, as described in regulation 2 (Therapeutic Goods Regulations 1990).
Criterion 2: Provide a justification of the life-threatening or seriously debilitating nature of the condition
Justify the severity of the disease in Australia (i.e. its seriously debilitating or life-threatening nature), based on objective and quantifiable medical information.
Your determination application must justify the:
life-threatening nature of the disease or condition based on figures of mortality and life expectancy in Australia
seriously debilitating nature of the condition based on morbidity over the course of the disease and its consequences on patients' day-to-day functioning
The serious debilitation or fatal outcome should be a prominent feature of both the target disease or condition and therapeutic indication, i.e. affect an important portion of the target population. The therapeutic indication is the proposed indication for ARTG registration, based on the proposed indication at the time of the determination application.
Criterion 3: Comparison against therapeutic goods registered in Australia for diagnosis, prevention or treatment
Criterion #3 is not required to be addressed for COVID-19 vaccines or treatments. See the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021.
You must establish that:
there are no registered therapeutic goods for diagnosis, prevention or treatment of the condition in question included on the ARTG
if such therapeutic goods are on the ARTG that the medicine will provide a significant improvement in efficacy or safety
Any reference to a registered therapeutic good must be limited to the conditions of the relevant ARTG entry. Therefore, a product that is administered or applied outside the approved product information (off-label use) cannot be considered a registered therapeutic good for the purposes of regulation 10L of the Therapeutic Goods Regulations 1990.
Provisionally registered goods on the ARTG are excluded from this comparison.
Registered therapeutic goods
You must review therapeutic goods included in the ARTG for diagnosis, prevention or treatment for the proposed indication in Australia, and provide:
details of any registered therapeutic goods for diagnosis, prevention or treatment (overview table of Tradename(s), ARTG number, holder of the ARTG entry, and the registered indication)
either a declaration that there are no existing therapeutic goods in Australia in accordance with ARTG entries at the date of determination lodgement
a justification demonstrating a likely significant improvement in safety or efficacy against existing therapeutic goods
If the medicine is already registered for a similar condition, a justification that the new indication should be considered on a provisional basis should be provided.
Justification of significant improvement in safety or efficacy
You must demonstrate, based on preliminary clinical evidence, that the medicine provides a clinical benefit over existing therapeutic goods for the indication that is the subject of the determination application (for either treatment, prevention or diagnosis of the condition) by addressing either of the following:
improved efficacy for the entire population relevant to the therapeutic indication
a better safety profile for the entire population relevant to the therapeutic indication
If new goods for the diagnosis, prevention or treatment of your proposed indication are included on the ARTG after you lodge your application, you will have the opportunity to submit a further justification of significant improvement in safety or efficacy in relation to those goods before a decision is made on your application.
Base the supporting evidence on clinical trial data. Surrogate endpoints require a justification, as explained in Clinical data supporting provisional determination.
Comparator studies against registered therapeutic goods are expected to be generated (for pivotal study reports). Scientific argument/justification may be appropriate for demonstrating significant improvement in safety or efficacy of the medicine relative to products not studied in available clinical trials (this may involve cross study comparisons).
For a claim of improved efficacy or safety (eligibility criterion 3(ii)), we will evaluate whether there is a high probability that patients will experience a clinically relevant benefit on the basis of preliminary clinical data. Therefore, this claim must be supported by evidence from summaries of the pivotal study reports that form the basis of the intended provisional registration application, and the justifications you are required to submit. You must consider the evidence/data in light of the particular characteristics of the condition (life expectancy, symptoms, pivotal study surrogate endpoints) and the existing medicines for the treatment, prevention or diagnosis of the proposed therapeutic indication.
TGA will not assess significant improvement in safety or efficacy against comparators that are a subject of concurrent determination or registration applications, those that are the subject of a provisional registration submission that is under review by TGA, or medicines that are currently provisionally registered.
Consider diagnostic performance (sensitivity and specificity), predictive values and likelihood ratios, among other endpoints, for diagnostic agents. Further information is available in the Guideline on Clinical Evaluation of Diagnostic Agents. Justify safety in the same way as for all medicines.
Criterion 4: Justification of major therapeutic advance
You must provide a justification that there is preliminary evidence that the medicine is a major therapeutic advance based on the following aspects:
the magnitude of the demonstrated improvement in safety and/or efficacy
the likelihood of the early data or surrogate endpoints to predict clinical benefit
the impact on patient outcomes taking into account both safety and efficacy
the magnitude of the advance in relation to other therapeutic goods registered for the indicated population. Where no product is registered on the ARTG, the comparison should occur against the accepted standard of care
the strength of the preliminary evidence, characterising the uncertainty (general TGA adopted guidelines about appropriate trial design apply)
You must include an assessment of the magnitude of the demonstrated improvement in safety or efficacy based on preliminary data (including surrogate endpoints). The demonstration of a medicine's clinically significant benefit based on improved safety and/or efficacy is not sufficient. Rather, there should be demonstration of a major benefit, i.e. beyond the level that could be described as clinically significant. Due to the uncertainty around the benefits and risks that are demonstrated by the available preliminary data, the observed effects would be expected to translate into a major clinical benefit in order to meet this criterion (for example a major improvement in mortality endpoints). Even if the benefit appears in one aspect only, you must assess the overall impact on patient outcomes taking into account both safety and efficacy.
The medicine should provide a therapeutic advance, in comparison with other registered therapeutic goods, where possible, by addressing a major or urgent unmet need for Australian patients in a substantial way. You must describe how and to what extent the medicine is expected to fulfil a major or urgent unmet medical need with reference to the therapeutic goods registered for the indicated population, the importance of the effects of the proposed medicine, and the added value of the proposed medicine.
The description of the strength of the preliminary evidence should include a brief outline of the main available evidence (for example number and type of clinical interim or final trials with clear delineation of pivotal versus supporting studies, sample size, design and key results) on which the claim is based. In the context of preliminary data, weak data evidence would be weighted less than comprehensive data evidence. See Justification of significant improvement in safety or efficacy for further information on cross study comparisons.
A medicine that demonstrates significant improvement in safety or efficacy may constitute a major therapeutic advance if for example, the medicine that demonstrates cure rates that are considerably higher than those observed in previous treatment options, while also replacing a standard treatment which has poor tolerability and potential for serious side effects.
Criterion 5: Clinical study plan
The purpose of the clinical study plan is to set out how you will achieve submission of confirmatory efficacy and safety data required for full registration. What constitutes sufficient evidence of a plan may vary from condition to condition. In all cases, the plan should address any uncertainties or identified gaps in data that would be required to transition the medicine from provisional to full registration on the ARTG within the registration period.
Ensure that supporting trials are designed and conducted in accordance with established international standards. Plan the pivotal studies to ensure that safety and efficacy, based on comprehensive clinical data, will be established as early as possible in the provisional registration period. In general, confirmatory trials should be fully accrued or near fully accrued following the end of the second round of assessment of the future related registration application. Please supply the recruitment status of the confirmatory clinical studies, whether completed recruitment, in progress or the recruitment is yet to start. Depending on the medicine and indication the extent of the level of accrual will be a consideration for eligibility.
You may provide very early studies as supporting documentation but these cannot be considered pivotal confirmatory studies.
Clinical study plan for provisional determination
You are required to provide sufficient evidence of a clinical trials plan to submit comprehensive clinical data on the safety and efficacy of the medicine within the provisional registration period. This will be required to be updated at various milestones during the registration process and in the provisional registration period.
The clinical study plan for provisional determination application provides an example of the types of information that you could include in your clinical study plan.
Clinical study plan for provisional determination application
Example clinical study plan for provisional determination application (docx,37kb)
Study and Status
Summary of objectives
Confirmatory nature
(i.e. uncertainty addressed)
Proposed submission date
Study ID #####
e.g percentage of target number of patients meeting a primary endpoint;
e.g. accrual status as percentage of planned enrolment:
not started;
started (ongoing or delayed-revised end date ;
Study ID ####
V1.0 Original publication Prescription Medicines Authorisation Branch March 2018
Update to currency of data required for criteria assessment
Prescription Medicines Authorisation Branch April 2021
V1.2 Update to criteria following changes to the legislation for COVID-19 medicines Prescription Medicines Authorisation Branch August 2021
Example clinical study plan for provisional determination application [Word, 27.17 KB]
Download Provisional determination eligibility criteria as PDF [227.79 KB]
Prescription medicines
ARGPM


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As technology increases, privacy decreases — so, how can smart cities make sure they are using data wisely According to James Lee, business development and program manager for Verizon, it is about taking ownership.
Socially responsible companies should agree to this, Amy McIlvaine, business development manager at AT&T Smart Cities, said. Read more here.


Elodea Canadensis in Belvedere Tiburon, CA can be a real problem for municipal and home owners ponds and lakes as well as golf course ponds throughout the State of California. Now there is help with controlling and removing Elodea Canadensis in Belvedere Tiburon. Check out our equipment on our home page.
Water plants are plants which have adapted to residing in water situations (saltwater or freshwater). They're known as hydrophytes and / or macrophytes. These types of plants must have specific adaptations for living submerged in water, and / or at the water's surface. The most popular variation is aerenchyma, but floating foliage and very finely dissected leaves are also popular. Aquatic plants can only flourish in water or in mud which is permanently soaked with water. They are therefore a popular component to wetlands.
Aquatic vegetation is typically a beneficial element of the water body, be it a lagoon or a fish-pond. The water vegetation is a source of food, refuge and oxygen to the wildlife currently in water-feature or body of water. Then again left unchecked a majority of these water plants can spread out promptly and constrain the activities in the fish pond or body of water. That's when these water plants come to be water weeds.
A quick definition of a water weed is a plant that grows (ordinarily too densely) in a area in a way that it obstructs the value as well as enjoyment of that area. Several common examples of aquatic plants which may turned out to be unwanted weeds are water milfoil, duckweed, pondweed, hydrilla, water hyacinth, cattail, bulrush, ludwigia, and many others. They can grow within ponds, lakes, streams, canals, navigation channels, storm water basins and channels, wetlands and lagoons. The particular growth could possibly be due to a wide variety of elements including surplus nutrients within the water or perhaps the arrival of rapidly-growing exotic species. The problems caused by water undesirable weeds are extensive, ranging from unsightly growth and nuisance smells to clogging of waterways, flood damage, motorboat damages, and even drowning and impairment of water quality.
Most often it's more beneficial and cost-effective to use a qualified aquatic weed control business to eradicate and control your aquatic weed problems. For California quite possibly the most competent company is DK Environmental. DK Environmental is located in the San Francisco Bay area however works aquatic weed removals everywhere in the State of California. The machines that DK Environmental employs is rather different to the western United States. Featuring its fleet of amphibious Aquamogs DK can access any sort of water body.


All of the gaming news sites have completely run out of things to announce, or tease, or ask for preorders for, and Jeff and J.D. have little to go on other than possibly-fake leaks and things that have no basis in reality. Mad Catz may be going out of business, the new Hitman had a verified leak, and that's, like, it. So instead they talk about J.D.'s dad, stealing money from banks, and anything other than fact.
This entry was posted on July 8, 2015 by jwaxo in Podcasts and tagged game news, game podcast, Hitman, mad catz, nintendo nx, overkill, payday 2, podcast, rock band, screen peekers, video games.


Okay darlings—today's post is a long one. But it's one I've been wanting to share for a long time, and suddenly a few weeks ago, it felt like the right time to finally write this all down. So grab your coffee, green juice or heck, a glass of prosecco (I don't know when you're reading this!) and settle in because I'm sharing my journey with health. Heads up, it hasn't been a smooth one.
At the end of last year, I was feeling, well, kinda crappy. I was tired constantly, even after a long night's sleep. I'd get random headaches, was irritable, and it seemed like every other thing I ate upset my stomach. During the day, I felt foggy and sluggish, and couldn't stay focused. I'd always considered myself a pretty healthy person—I workout, I eat healthy and I get a decent amount of sleep—so, why was I feeling like this?! Could it be my twenties coming to an end? Surely not, right?
Then in December, something clicked. I'd been doing a lot of reading and researching and fell upon some pretty incredible data. Life-changing, really. So, I started making changes—some small and some major, and awesome things have happened. But, before I delve into the amazing changes I've been experiencing you need to know what I've dealt with along the way. My journey with health and wellness has been a bit of a roller coaster. That first vertical drop, the one that leaves you feeling like your stomach is in your chest, happened in college. So, let's turn back the clock and take a look at what my life looked like then.
The first two years of college were pretty normal. Other than gaining the obligatory freshman fifteen, my health was pretty good. I played volleyball that year, regularly went to the gym and walked a lot—definitely and upside to college campuses! But sometime in my junior year, things changed. I felt crappy all the time, I was tired for no good reason and every thing I ate—healthy or not—sent my body into freakout mode. I'd get the most painful, debilitating stomach pains that would last anywhere from a few minutes to several hours. Back then, I blamed it on the boozy Tuesdays at the Aardvark, our local college bar, and the late night pizza or Taco Bell that followed, or my long sleepless nights at the library, where my dinner consisted of Skittles, granola bars and coffee. I assumed this was normal, that all college students felt like this. I mean, I wasn't exactly doing my body any favors and surely this was the punishment—right? After dealing with it quietly for several months, I finally asked one of my best friends if she'd ever experienced something like that. She looked at me like I was crazy—"maybe you should see a doctor" was her response.
I suppose I already knew something wasn't quite right, but having someone else voice my thoughts out loud, made it all too real.
So, I started making changes and that's when the roller coaster ride really began. I started by going vegetarian for a while, cutting out dairy when I could, exercising more and switching out beer in lieu of vodka sodas—you know, real healthy choices! Being vegetarian was great—I felt lighter, had more energy and less stomach pain, but the better I felt, the easier it was to make exceptions to my new diet plan—a slice of pizza here, a beef taco there, queso, chips and Corona's at our favorite taco joint. Before I knew it, I was right back where I'd left off. Miserable and in pain. The rest of college followed this same pattern. I'd go on a super healthy diet and then fall back into my old habits just a few weeks later.
When I look back, I think the real reason I was never able to conquer my problem is that none of my "fixes" left me feeling 100% better. Even during my vegetarian days, I'd still get terrible stomach pains. The only difference was that it happened a little less frequently.
Now, let's fast forward to the post-college, new job, I-don't-know-what-I'm-doing-with-my-life phase. This was surprisingly one of the healthiest times of my life and here's why. I was living in my parents back house, eating whatever healthy meal my mom prepared, I wasn't drinking nearly as much, and I didn't love my job, so I'd started a food blog on the side and most of the time I featured healthy recipes. Around this time, I also started taking a probiotic, Align, which helped tremendously. It seemed as if I'd finally found the magic combination!
Let's fast-forward again. For a long time my stomach pains seemed to be pretty much gone and it was amazing. I felt like I was living again. Everything was new and exciting! I moved to Chicago, started a business, got engaged, then married and traveled to some really amazing places in between, but about a year and a half ago, things started to go downhill again. I found myself in one of the most stressful stretches of my career as a designer. For the first time, I had tried to hire outside help. I was beyond my scope with developing and figured this was the next step in growing my business, but with every new developer I hired, something went wrong. One wouldn't respond for weeks at a time, making it impossible for me to do anything and the client, understandably, was furious. The next one ended up getting so sick that she could no longer work. To top it off, my health was declining. I felt horrible, everything I ate made me sick, I couldn't sleep, I was on edge all the time, nothing sounded fun and my stress levels were at an all-time high.
Finally, Rob suggested I go see a specialist—that was a wake up call. The way I was currently living my life wasn't working, and something had to change. I was embarrassed I'd let it get this far and that I hadn't been able to fix it on my own, but he was right. It was time for some intervention.
My doctor's first question was "is your job stressful?" Uhh, yes, and that was putting it lightly. They ran a bunch of different tests to make sure I wasn't allergic to any specific foods and also took some scans to make sure there wasn't something bigger at play. Everything came back 100% normal. Part of me was relieved, but part of me was frustrated. If nothing was "wrong" with me, what was causing me to feel so terrible?!
When I finally got to talk with my doctor, he basically said stress was wrecking havoc on my body and that I needed to find a way to better manage it. He also told me that I likely had a lot of food sensitivities, even though I wasn't actually allergic to anything, so he suggested I cut out artificial sweeteners, greasy fried foods, and cut back on dairy and caffeine.
What that experience really triggered in me was the serious need for some major lifestyle changes.
What happened next was a long process—one that's still happening. One of the first major changes I made was closing my design business—the major stressor in my life at the time. It's been amazing to see what that decision has led to, and I'm sure that what I'm doing now would not have been possible without that decision. Even with making that big decision, I still found myself yo-yoing between extremely healthy and losing my footing.
But then in late December, everything started to click, and for once in my life I feel like I actually have control over my health. The biggest difference? Having the knowledge to make informed decisions. Like I mentioned earlier, I've been doing a lot of reading and it's really opened my eyes to how my body works. So, in January, I really started making some big changes to my lifestyle. The biggest change has been my diet (more on this in the near future), and also my exercise routine, beauty regimen, attitude, and my overall outlook and relationship with my body. I'm finally, after all these years, listening to my body instead of ignoring its flashing red lights.
Guys. Amazing, amazing things have happened since then.
I haven't had any of those shooting stomach pains and after a lifetime of dealing with oily skin and breakouts, my skin is finally clearing up without the help of prescription meds. I feel awake, well-rested, excited, alert and energetic. Those foggy moments I used to have on a daily basis are gone and I sleep like a rock at night. I feel the more confident, powerful and joyful than I have in my whole life. It's hard to explain how amazing it feels, because really you can't truly understand it until it happens to you (and maybe it already has—good for you!). The feeling is addicting, which is good, because I know how hard it can be to make healthy choices after a long work day or push yourself to go to the gym when you really just want to drink wine and watch HGTV. But, feeling this wonderful is really all the motivation I need.
There's an assumption in our modern world that if you're a certain weight or look a certain way that you're healthy, but that couldn't be further from the truth. Being healthy goes so much further beyond weight and body type and that was another big reason why I wanted to share my health journey with you guys. I've had so many people tell me that I "seem so healthy", and while it's nice to hear, it wasn't really what was happening behind the scenes. Now that you know the full story, you can understand where my passion and enthusiasm about health and wellness comes from. Before this gets any longer (seriously, you're amazing if you're still reading this!), if you've struggled with your health or you feel like you're not living your best, you're not alone. It can feel so isolating, and it's a scary thing to share (writing this post wasn't easy), but I hope that through my story I'm able to inspire some of you to make changes of your own so that you can feel your absolute best too!
I'm sure the roller coaster ride isn't totally over, but I'm hoping that I'm done with those big vertical drops and loops once and for all.
Have you dealt with un-diagnosed or "mystery" health issues before? What tips do you have for feeling your absolute best?
P.S. You guys showed a huge interest in health and wellness in my reader survey at the end of last year, which was really really exciting and I've already started sharing more of these types of posts! It's something I've always been passionate about, and I look forward to sharing more of my journey with you guys. So, if you have any specific questions or topics you'd like covered feel free to leave them in the comments below, and if you want to talk more privately about it, feel free to shoot me an email because I know talking about health on the internet is a little public, ha!
P.P.S. This outfit is one of my favorites EVER. It's so simple, but it's so me—perfect for this story! Details are below!


The mission of the Spring Street Missionary Baptist Church Youth Dance Ministry is to witness through dance expression, to enhance Christian lives by providing an opportunity where the entire body can be used in worship and glorifying God. To keep our focus on whom we live, move ,and have our being. They currently dance every second Sunday during morning worship service.


When it comes to buying smartphones, it's always tempting to go for the current flagship models, especially those coming from the Big Two, namely Apple and Samsung. After all, who doesn't want to have a phone at the bleeding edge of mobile technology—right at one's fingertips and accessible at all times? Unfortunately, that's becoming more and more difficult and impractical these days, what with flagship phone prices quickly soaring past the USD 1,000—or PHP 50,000—mark? And the way things are going, we can expect the prices to approach numbers twice that in the near future. At this rate, it's only going to be those with the deepest pockets who'll be able to enjoy phones with the latest features and specs.
Thankfully, some smartphone manufacturers such as Xiaomi have dedicated themselves to delivering mobile devices with similarly awesome specs and features, but at prices that most of us can easily afford. Last month, they've done so again when they revealed their latest offering, the Xiaomi Mi 9.
In this Poundit review, we're going to give this wonderful piece of hand candy the thorough-looking over, just to make sure that it truly does offer the most bang for our buck.
Let's first talk about the things we've just listed above—the Xiaomi Mi 9 specs and features. Just look at what you're getting for half the price of flagship phone: a wide screen, a gorgeous high-resolution Super AMOLED display, monstrous 2.86GHz octa-core processing power, a rear triple camera setup, and in-display fingerprint scanning. It even supports a face unlock feature and 4K 60FPS video recording!
If you've ever drooled over today's most current (and most expensive) flagship devices, then you know that these tidbits are usually exclusive to those smartphones. Before the Xiaomi Mi 9, the only way you could experience them was to fork over a small fortune. Now, though, you can enjoy them at a price that's most likely still within your means.
But do these specs and features actually work as advertised, or are they just part of the marketing campaign designed to entice you to buy it? We're happy to say that they definitely do! Everything you see listed above delivers on their promise. In fact, Xiaomi has done such a great job here that it's hard to look at our own expensive flagship smartphones and not wonder: if Xiaomi can provide more or less the same premium experience at a considerably lower price, then where did the rest of our hard-earned money go? Where is the value?
Of course, there are answers to that, which we'll get to later. But if you're looking at this review and want to desperately know if the Xiaomi Mi 9 is for real when it comes to offering the features and specs of a flagship phone at a dramatically lower price tag, then you can rest assured that it is.
With that out of the way, let's talk about the rest of what the phone offers. First of all, it's worth noting that the Xiaomi Mi 9, at first glance, looks very similar to its predecessor, the Xiaomi Mi 8. However, there are key differences that you'll quickly notice if you own the previous-generation phone. First, the huge, gouged-out notch has been drastically reduced to a small teardrop-shaped one to house the 20MP front-facing camera. The screen has also been made larger on the Xiaomi Mi 9—from 6.23 inches up to 6.39 inches. These may seem like marginal upgrades from afar, but on-hand and up-close, the phone appears significantly different.
The body of the new phone also feels reassuringly hefty and solid. Being a glass-and-metal sandwich handset, it feels very similar to some of the other new smartphones out there. The power and volume buttons are where you'd expect them, although it also has a dedicated Google Assistant button that annoyingly can't be remapped to anything else. A minor quibble to be sure, but something to note of if you're the type who wants full control over their phone's functionality.
What is worth noting, however, is that the phone is encased in Corning Gorilla Glass 6, which is a nice upgrade to the Gorilla Glass 5 sported by its predecessor. This means that it's going to be much more resistant to scratches that could result from you carrying it around your pocket or anywhere else without a screen protector.
The body's design is also where we encounter one of the possibly negative points of the Xiaomi Mi 9, and that is its lack of a 3.5mm headphone jack. While we do accept the fact that this is becoming the norm these days, we believe that a headphone jack is still one of those old standby features that instantly adds a bit more audio functionality to a phone. So, if you were planning to use your favorite wired headphones with the Xiaomi Mi 9, then you'll have to find some other way to do it.
There's also the fact that the Xiaomi Mi 9 is not waterproof, nor is it splash-resistant. It has no IP rating, period. As such, you'll have to take special care of your phone around liquids. Then again, who really willingly risks their smartphone getting wet anyway, IP rating or no?
The Xiaomi Mi 9 also delivers excellently when it comes to its display. As we said, the screen is larger this time around, with minimal bezels and a teardrop notch to give you as much screen real estate as possible. The Super AMOLED screen, a current flagship standard, gives some of the most vibrant and vivid colors around, as well as a very rich and deep black.
The display's 18:9 aspect ratio, coupled with its 2340 x 1080p, 403ppi resolution also makes for some of the finest visual media playback experiences we've ever had in this class of smartphones. Whether you're a gaming fiend or a video streaming junkie, the Xiaomi Mi 9 delivers a visual banquet that's hard to resist or look away from.
The Xiaomi Mi 9's display, like Samsung's current flagships, also automatically kicks up the brightness when it senses that you're standing in bright light so as to reduce glare and reflections. While this is clearly convenient, it also messes with the colors a bit, making them look a bit too vibrant. It's nothing that can't be fixed with a bit of fiddling with the settings, however.
Overall, the Xiaomi Mi 9 can rock it with the best of them when it comes to display.
Now let's delve deeper into the specs and how it affects the Xiaomi Mi 9's performance. One of the best things about this phone is that it's one of the first to sport the Snapdragon 855 octa-core processor, Qualcomm's latest chip. With 6GB of RAM fueling this beast of a processor, the Xiaomi Mi 9 is more than capable of going head to head with Samsung and Apple's flagships in terms of speed, power, and graphics. You can multitask to your heart's content—or game at full settings—without having to experience annoying stutters or laggy sections.
This power comes at a price, however, in that the Xiaomi Mi 9's battery life isn't as long as you might like it to be. Granted, the Snapdragon 855 is a lot more power-efficient than the Xiaomi Mi 8's Snapdragon 845, but you may find yourself needing to charge the phone every night to get the most out of it. This is due to the fact that the battery is only sporting 3300mAh capacity, which is a far cry from the flagship standard of upwards of 4000mAh.
Thankfully, this is somewhat balanced out by Qualcomm's Quick Charge feature, which allows you to wirelessly charge the Xiaomi Mi 9 at 20W, or to charge it via an adaptor and wire setup at 27W. This should be more than enough to appease all impatient phone enthusiasts.
When it comes to taking photos and videos, the Xiaomi Mi 9 excels as well. Its rear triple camera setup, headlined by a massive 48 megapixel Sony IMX586 quad sensor, can stand tall with the rest of them when it comes to photo and video quality. This is then supplemented by a 16 megapixel ultra-wide module camera, and a 12-megapixel telephoto camera. The end result of this triple-threat matchup is clear and detailed imagery that any photography aficionado would be happy to upload onto their social media profile.
That being said, there are still some slight issues. First, the Xiaomi Mi 9 shoots only at 12MP at default. If you really want to take pictures with the complete 48MP, you'll have to toggle it yourself, and this unfortunately comes with the HDR being disabled. Still, even with this vital feature turned off, the image output is still quite remarkable, with very little noise and a very high amount of detail and color fidelity under bright conditions. The phone also fares well in low light conditions.
Things are much more positive with video, as not only does the Xiaomi Mi 9 record at a very clear 4K 60FPS, but you can also encode the video output to H.265 format, allowing you to share the footage you've captured much more easily without sacrificing quality. There's also a Night Mode that allows you to capture video at low light conditions without too much visual noise.
We never thought we'd see the day when a budget phone manufacturer would actually do the herculean task of offering a smartphone that has all the specs and features of a premium flagship device, but at the cost of a midline phone. However, Xiaomi has clearly done it with the Xiaomi Mi 9.
Certainly, we can point to how the phone has no headphone jack, or the fact that it has zero water resistance. We can even complain about the Google Assistant button if we really want to be nitpicky about it. However, it can't be denied that Xiaomi has given us a smartphone that can go toe-to-toe with the Samsung Galaxies and the Apple iPhones of today, all while asking us to pay considerably less than what we're getting. That alone makes the Xiaomi Mi 9 worthy of our praise, and your serious consideration when making your next smartphone purchase.
That said, if you are looking to cop the Xiaomi Mi 9, why not buy it online at Poundit.com? Not only do we offer the Xiaomi Mi 9 at the best possible prices, you'll also be able to take advantage of our nationwide door-to-door shipping. More than that, everything we sell is guaranteed to be 100% brand new and authentic, as well as being covered by the manufacturer's original warranty.
Finally, if you buy your Xiaomi Mi 9 within 30 days after the publishing of this review, then you'll be eligible to use a time-exclusive voucher code that will knock off PHP500 off the Xiaomi Mi 9's price! Simply type in REVIEW201914 upon checkout, and the discount will be applied, no matter if the reviewed product is marked down, on sale, on promotion, or bundled with other products. You have to hurry, though, as the code will only be active until the next 30 days!


Speaking of the 10″ Lenovo IdeaPad S10 netbook, over at liliputing, a liliputing reader, Tommy Yoo, took his S10 completely apart.
For a lot of pictures of the internals of the S10, click the link below.
This entry was posted in Articles, Intel Atom, Lenovo, Netbook, News, Reviews. Bookmark the permalink.


text:
Q: Parsing the date, and converting to DATE for MYSQL? So I am using DateFormat to convert a date (that I parsed form a CSV) to YYYY-MM-DD format, so I can INSERT it into a MYSQL column which is in DATE format.
I am using DateFormat, but my date output keeps coming out like this:
Mon Dec 29 00:00:00 CST 2014
Tue Dec 30 00:00:00 CST 2014
Tue Dec 30 00:00:00 CST 2014
Tue Dec 30 00:00:00 CST 2014
Wed Dec 31 00:00:00 CST 2014

How can I convert this date to the format I am looking for?
DateFormat formatter;
Date date;
formatter = new SimpleDateFormat("yyyy-MM-dd");

date = formatter.parse(date_parsed[0].toString());
System.out.println("DATE=" + date);

A: Try this:
SimpleDateFormat formatter = new SimpleDateFormat("EEE MMM dd HH:mm:ss z yyyy");
String dateStr = "Tue Dec 30 00:00:00 CST 2014";
Date date = formatter.parse( dateStr );
formatter.applyPattern("yyyy-MM-dd");
String newDate = formatter.format( date );
System.out.println("DATE=" + newDate);

Output :
DATE=2014-12-30

redpajama_set_name: RedPajamaStackExchange


Back in 2007 I did an article on the site on why a nickel is now worth a dime. A year earlier, I wrote a similar article called A penny saved is 1.4 pennies earned. The trend I was hinting at will continue to accelerate, and investors may want to take note. The supplies of certain rare elements are running out, fast.
As I noted in the penny article, prior to 1982 pennies were 95% copper and 5% zinc. Due to the rising value of copper, the U.S. Mint changed the composition in 1982 to 97.5% zinc and 2.5% copper. There are many factors at play here, but the basic equation always boils down to supply and demand, and the supply of some precious elements is running out fast. The U.S. Mint is going to have to rethink that composition again soon, since some experts predict the world will run out of zinc in less than 30 years! My guess is the U.S. Mint will soon choose to simply do away with the penny altogether.
Copper supplies will hold out much longer, and recycling is becoming so profitable copper has become a big target for thieves. Still, surging demand is driving the price of copper up fast. The price of copper tripled between 2003 and 2008. Demand from developing economies like China is fueling much of the increase.
What other elements are on the road to extinction? We are all aware of the continued rise in value of silver and gold, but the one we should be watching really close is platinum. If you started buying U.S. bullion platinum coins in 1997, you are probably pretty pleased with your investment. Before the economic meltdown in 2008 the price of platinum spiked to $2250.00 an ounce, over twice the value of gold during that period. A big factor in the rising price of platinum is that it has a key industrial use as a component in smog-reducing catalytic converters for automobiles.
Some other elements that are running out fast (though they have nothing to do with collecting coins) are Europium (used in LCD displays for computers and televisions) and Indium (used in flat screen displays and GPS systems). Think about this: in about 5 years most people will be a walking GPS (cell phones). One expert, Armin Reller from the University of Augsburg, Germany, predicts the world supply of Indium will be exhausted by 2017.


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text:
eWeek (Enterprise Newsweekly, stylized as eWEEK), formerly PCWeek, is a technology and business magazine. Previously owned by QuinStreet; Nashville, Tennessee marketing company TechnologyAdvice acquired eWeek in 2020.

The print edition ceased in 2012, "and eWeek became an all-digital publication"), at which time Quinstreet acquired the magazine from Internet company Ziff Davis, along with Baseline.com, ChannelInsider.com,  CIOInsight.com, and WebBuyersGuide.com.

eWeek was started under the name PCWeek on Feb. 28, 1984.  The magazine was called PCWeek until 2000, during which time it covered the rise of business computing in America; as eWeek, it increased its online presence and covers more kinds of worldwide technologies.

History

The magazine was started by Ziff Davis to cover the use of computers as business tools.

Team members that started PCWeek included John Dodge, the first news editor; Lois Paul, the first features editor; and Sam Whitmore, the first reporter, who later went on to become editor-in-chief.

Chris Dobbrow, who "joined Ziff Davis Media ... as the associate publisher of PC Week, ... worked his way up the ladder at Ziff Davis, ... eventually becoming executive vice president." A short story in The New York Times about him said "He left in 2000 to join ... Last week, ... landed .. At eWeek. As the publisher. One step above the job he had 15 years ago."

At the time, many magazines at the time already covered business computing, such as Datamation and Computerworld.  There were also magazines dedicated to hobbyist machines, so it seemed there was no place for a weekly issue to fit in. The first few issues had only 22 pages of advertising, but then PCWeek began establishing itself.  By the end of the first year, the average number of advertising pages for the last month was 74.875.

Covering The New York Times
Twice eWeek had stories about The New York Times having its guard down:
 The Times' web site infected computers of on-line subscribers one weekend in 2009
 Midweek, even more visibly that above, the Times' website was down for over two hours, mid-day; the magazine used the word "nefarious."

An Atlantic magazine titled "How Not to Get Hacked Like the New York Times" explained how the first hack on the Times worked; the Times reported on a second (same month) hack against NYTimes.com with the headline "Times Site Is Disrupted in Attack by Hackers."

Buyers' guides
John Pallatto, a writer for PCWeek in its first year, produced a full buyer's guide on all DOS-compatible PCs on the market.

Early promotional publications from PCWeek show them describing their key audience as "volume buyers", that is, people and companies that would buy PCs in bulk for business purposes.  With this the magazine was able to show big computer companies that advertising in an issue of PCWeek was the best possible way to get their product seen by the biggest and most important buyers.

Later success
PCWeek grew.  Scot Peterson became eWeek's main editor in 2005, having been, a Ziff-Davis employee
since 1995, and previously held the title news editor.

People involved in between PCWeek's initial success and change to eWeek were David Strom, Sam Whitmore, Mike Edelhart, Gina Smith, Peter Coffee, Paul Bonner, current editor Chris Preimesberger and many others.

Jim Louderback, a lab director at PCWeek as of 1991, describes how they were able to "get a product in on Wednesday, review it, and have it on the front page on Monday" and that "that was something we were the first to do".

In 2012, eWeek and other Ziff Davis assets were acquired by the company QuinStreet, which also runs other tech-oriented publications.

Evolution
As the whole PC Industry evolved, PCWeek grew, and also developed a very active audience that spoke of their experiences, good and bad.
Successor eWeek is even more oriented towards "Lab-based product evaluation," and covers a wide range tech topics.

Writers
Among former/current writers are:
 Jessica Davis
 Scott Ferguson, former Editor in Chief of eWeek, 2006 - 2012 (when eWeek stopped their print edition "and eWeek became an all-digital publication").
 Todd Weiss, Senior Writer ("all things mobile")

Influence
A famous part of PCWeek was the fictional gossip columnist by the name of "Spencer F. Katt".  The column would cover all sorts of rumors and gossip about the PC Industry, and the character of Spencer F. Katt became a famous icon of the entire world of computing.

PCWeek had influence on the PC Industry that it covered and the success of business PCs contributed to the success of PCWeek. John Pallatto characterizes the rise of PCs in 1985 as a "social phenomenon", and says that "the most sought-after status symbol on Wall Street in 1985... was the key to unlock the power switch on an IBM PC AT".

PCWeek was licensed in other countries, notably Australia, where it was first published by Australian Consolidated Press. Towards the end of the 1990s, the title shifted to a publishing partnership between Ziff-Davis and Australian Provincial Newspapers where its final Australian editor was Paul Zucker.

One story from PCWeek that is well known is their coverage of "the famous 1994 flaw in the numerical processor in Intel's Pentium chip".  The news they broke on Intel's processor, along with other research, caused Intel to actually pull back and fix their chips before offering new ones.

Current editor in chief Chris Preimesberger, who joined eWEEK in 2005 as a free-lancer, now runs a staff consisting of mostly free-lancers, many of whom have worked full time for eWEEK in the past and at other IT publications. The readership has been loyal through the years and now consists mostly of veteran IT professionals, company executives, software developers, investors and other people interested in the ebb and flow of the IT business and trends in products and services.

Training
After 14 years at PC week, Sam Whitmore started his own firm (Media Survey). The latter, after over 2 decades, began a fellowship to train future reporters.

References

External links

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Business magazines published in the United States
Computer magazines published in the United States
Defunct computer magazines published in the United States
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Magazines published in Boston
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redpajama_set_name: RedPajamaWikipedia


Each of the live sessions recorded for this course covers a few topics in detailed, thorough and patiently constructed discussions covering wide-ranging areas related to the practice of Chinese Medicine. At many American medical schools seminar learning has replaced lecture style formats. The seminar setting has proven to be a powerful forum for learning for our students as well. During each of the seminar sessions, the practitioners attending propose several diverse subjects and in engaging, interactive discussions, the many dimensions of the issue are surfaced, pulled apart and probed. Any and all questions are welcome and are thoroughly investigated.
In real-time version, this program has been running virtually uninterruptedly since May of 2000 as The Six Month Advanced Training Program in Acupuncture. Scores of practitioners and students have enthusiastically attended these seminars.
Jack clarifies each subject with immediate practicality, while consistently exposing the discussion of each area of concern in great detail. Multiple approaches to both acute and chronic conditions are explored, responding to the needs of each of the participating practitioners and their patients.
When Is the Patient's Report of Numbness Invalid?
This course is approved for PDA's (CEU's) by the NCCAOM and the states of California, Florida, Illinois and Texas. The NCCAOM designation for this course is ACHB 319-036. It is given under California Continuing Education Provider Number CEP 592. The state of Florida CE Broker Tracking Number for this course is 20-184786, and it is given under Florida Continuing Education Provider Number 50-7646. It is given under Illinois Acupuncture Continuing Education Provider License Number 225.000013 and Texas CAE Approved Provider Number CAE00019. In order to smooth the way in taking this course, please refer to 'Download Instructions' before ordering this course.
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Musings On The Science of Business, And The Business of Science
What is (should be) the definition of gambling?
Long flights are an ideal way to get rid of those podcasts that you never quite get around the listening to. So on my 13 hour flight to Beijing, I listened to a commissioner of fantasy sports (what a job!) talking to KQED trying to defend daily fantasy betting sites like FanDuel and DraftKings against charges of being gambling houses.
His argument is the old one that says anything requiring skill isn't gambling. I don't think anyone really buys that argument, since by that definition there's nothing in vegas aside from maybe slot machines is gambling. But what I found curious was the comment from Michael Krasny, the host, that regulators didn't have a problem with betting in the old season-long format, but only now when it became daily.
This issue of timescale rings true to me, and strikes me as being quite similar to other "vices" that we have always had trouble defining. For example, we're perfectly fine with coffee (and for a long time cigarettes) but not many other psychoactive substances. Of course, the most famous example has to be that for obscenity, and Potter Stewart's famous line that "I know it when I see it".
I think the difficulty in each of those cases is finding an "objective" characteristic of the good (or I guess bad) itself (maybe I'll just use "it"). Maybe we should instead define it from the perspective of the individual consuming "it". In all these cases, the reward itself is so incredibly impoverished, such that the pleasures of consumption is tied to some very specific aspect of the whole experience. Taking "it" away and the whole experience loses all motivational value.
In the case of coffee, people seem to consume at least two qualities. The caffeine and the taste itself (the fact that there is such a product as decaf is a pretty good indication). For cocaine, I'm guessing not. In the case of fantasy sports, there is the smack talking and the bonding experience. Take away the money, and plenty of people would still play (at least I did as a poor grad student). There's much less opportunity for that when we strip it down to a day.
I think it can also explains what Potter Stewart had in mind in his famous statement. In a particular time and place, it's quite obvious what's obscene. But consumption experiences have a way of changing. Move it into the art gallery, wrap it in a social experience, and the meaning to the consumer changes.
This all seems so sensible that I'm sure someone has already written about this (or maybe this is what happens 12 hours into the flight). But if they have, it's too bad that we're still hearing the same flawed argument about requiring skill = not gambling. So here's my proposed definition of gambling and other "vices":
An activity where immediate gratification is the sole motivation for its consumption.
ACR 2015 Consumer Neuroscience Roundtable
A bit delayed but here are some thoughts on the consumer neuroscience roundtable at ACR 2015. One of the notable aspects was the involvement of industrial participants. I found it alternatively depressing and invigorating. First the depressing part. The involvement of the industry participants really highlighted for me the gulf between what industry wants and what academia can deliver. This really underscores the lack of a clear value chain that connects basic researchers and practitioners.
In a mature and functional product development value chain, there is a virtuous cycle where basic research creates new possibilities, which are exploited and refined to fill some need, which in turn creates more demand for basic research.
But in a new or dysfunctional one, basic researchers create possibilities that are not exploited, for a variety reasons. Alternatively, industry want deliverables that cannot be satisfied, for a variety of reasons. It's like the old Tolstoy quote, "Every happy family is happy in the same way. Every unhappy family is unhappy in its own way." Except instead of Anna Karenina, we get (i) moonshots in the sense of "if we can do X, everything is going to be different", and (ii) vaporware, "everything is going to be different!
The really depressing part is that, instead of thinking strategically about closing this gap, everyone is being asked to be all things to all people. Academic researchers are told that, "Show that your methods works in the way that industry would want to use them," while practitioners are told that, "Show that your methods work and provide scientific proof."
Now, both of those requests are perfectly reasonable in themselves. Nobody can argue against them. But imagine if the pharmaceutical or any other field worked this way. A chemist finds some new molecule, instead of passing it along to the next part of the chain, they need to find their own disease target, then do their own trials, and perhaps then sell it to hospitals and market to doctors and patients.
THESE THINGS DON'T HAPPEN IN A VACCUM.
Okay, now the (cautiously) optimistic part. Even given so much pessimism, marketers and businesses remain intrigued and excited by neuromarketing. Even without much strategic planning, there are optimistic signs that neuroscience can indeed deliver value. Nothing like "pushing the buy button", but something more interesting. Imagine what can happen with a bit of planning, coordination, and division of labor.
Business of Science (5)
Consumer Neuroscience (6)
Consumer Research (3)
fMRI (1)
Homo economicus (1)
Marketing Research (5)
Neuroeconomics (6)
Neuromarketing (13)
Science of Business (4)
Translational research (1)
© Ming Hsu


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You are here: Home > HEi Know > HEi News > Weekly HE news review: Storm clouds gathering?
Weekly HE news review: Storm clouds gathering?
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With Brexit inevitably dominating the headlines this week, Rhiannon Birch, Director of Planning and Insight at the University of Sheffield, looks at what else was also making news in higher education.
In a week where the main news focus was the meaningful vote, the rejection of the EU Withdrawal Agreement and speculation as to where this leaves the UK, it would be easy to focus on Brexit. You don't have to go too far to find dire warnings of the consequences for the sector and the Business Times has the latest summary of a perfect storm facing HE. It's reasonable to say that on Brexit we know no more now than we did last week about what this means for our longer term future and keeping a close, informed eye on developments while planning for the worst seems a sensible approach whether that means preparing for no-deal or proactively building post-Brexit relationships with the EU.
This week's round of speculation around the possible outcomes of the Augar Review continued to focus on likely recommendations on fees and loans with articles on the potential implications for students and institutions featuring in the FT, Guardian and BBC. However, what little of the commentary has considered thus far is that the devil is unlikely to be in the detail of the Augar recommendations. What Browne, Dearing and other higher education reviews over the years show is just how far the reality of Government implementation varies from the original recommendations. The kite-flying is fun to watch but it will be what Government does with the Augar Report that really matters.
With Westminster focussed on English HE policymaking and apparent leaks from Augar, it's interesting to see stories on similar challenges facing HE in Scotland where College lecturers are striking over pay and the Education Secretary, John Swinney, has rejected Universities Scotland's argument that ongoing real term cuts are unsustainable. He suggested that the sector is good at finding new sources of income itself and rebuffed the argument that a sustainable level of core government funding is essential for the staff and facilities that enable universities to compete for these resources.
Brexit aside, this week has seen some new and interesting developments in the UK higher education story. The debate around unconditional offers took a week off as discussion moved to the familiar refrain of the potential for post-qualification admissions, this time reimagined in a UCU report. The report presents a vision of higher education admissions as a student-centred process which supports decision making across all options including apprenticeships and employment. This was balanced by a HEPI blog which reports that a quarter of school exam grades are wrong so whatever the process for admissions there is evidence of subject areas where grades may be a less reliable indication of an applicants' ability.
A word of sense also emerged on the degree inflation debate as Phil Pilkington, writing for WonkHE, explored the possible academic causes beyond the negative headlines. In the context of earlier coverage, it seems that degree inflation will continue to be used in the media as a lightning rod for a wider narrative around marketisation, value for money and the qualities of a degree. But understanding the causes of the change and where it sits in wider HE policymaking, rather than relying on simplistic assumptions that degree inflation is just a bad thing, offers a new way of thinking about the issue.
Finally, there was a lovely story on an early display version of the periodic table being found underneath a lecture theatre at the University of St Andrews. The article is an interesting counterpart to a recent piece in the Conversation about how the current iconic design emerged.
© 2013 Media FHE, all rights reserved


Vincent D'Onofrio has signed on to play the brother of Robert Downey Jr's character in The Judge, the Warner Bros dramedy that also stars Robert Duvall. Bill Dubuque was pegged to pen a new draft of the Nick Schenk script, about a big-city lawyer (Downey) who returns to his childhood home where his estranged father (Duvall), the town's judge, is suspected of murder. He sets out to discover the truth and along the way reconnects with the family he walked away from years before. David Dobkin is directing, and Downey and Susan Downey are producing with Dobkin. D'Onofrio just completed the off-Broadway show Clive opposite Ethan Hawke and Zoe Kazan. On the big screen, he just wrapped the action comedy Pawn Shop Chronicles and next appears in the indie Broken Horses with Anton Yelchin and Thomas Jane. D'Onofrio is repped by UTA and the Collective.


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The study of costume design in cinema and television. Featuring exclusive articles, news, interviews, videos, podcasts, essays and competitions.
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Clothes from Fantasy & Sci-fi, Film Reviews, Girls in Films, Guys in Films
UK Film Review: The Road
19 Nov '09 /
Starring: Viggo Mortensen, Kodi Smit-McPhee, Robert Duvall
Directed by: John Hillcoat
Viggo Mortensen stars as 'Man' in director John Hillcoat's adaptation of Cormac McCarthy's unfilmable novel The Road; proving that it is filmable, if not exactly fun.
The Road (2009) is about as miserable a Hollywood film as you are likely to see. Watching it is like dying for two hours. It is pegged as a journey for survival, yet as the story offers no possibility of this, life becomes merely a reprieve. If such wretchedness does not put you off however, a rewarding passage awaits; to vicariously experience what you hope to god you will never have to face in real life.
Australian John Hillcoat has only four features under his belt including this one. Up until now The Proposition (2005) was regarded as his most notable achievement. An outback set revenge western shot as a ghost story, it was given the thumbs up by critics and public alike. Even if some people did not know what to make of this genre splicing, everyone could agree Hillcoat realised his vision with astonishing attention to detail.
The Road is just as precisely made; only instead of dusty plains we get deserted roads and decaying forests. It is a tough trip to weather as there is practically no respite. This is credit to Hillcoat. He does not back away from a post-apocalyptic world minus cyborgs in trench coats and Kevin Costner delivering the mail. There is nothing to see here but grey.
Costume designer Margot Wilson worked with Hillcoat on The Proposition, accurately reproducing late 19th century military and civilian attire and Aboriginal dress – indeed she won an Australian Film Institute award for her trouble. Although The Road cannot be classed as a period film as such, Wilson has created a similarly homogenous look, here comprising layered quilted jackets and baggy unflattering knitwear, bobble hats and carrier bags used for socks. Garments are worn for two reasons: to keep dry and keep warm.
Food is all anyone really cares about in The Road. Water can be found and boiled, yet food is so scarce that the desperate have been driven to cannibalism. Those who choose to abstain survive on tins of syrupy fruit and steamed chocolate, which might help explain why everyone has teeth as rotten as the scenery. Just a minor touch this, but another example of Hillcoat's dedication to getting it right. Toothpaste is an obvious luxury, and luxuries are seldom plentiful at the end of the world.
Although, as this straightforward set-up of travelling and scavenging is requisite of 'Man's' world, it does trap the narrative on a hamster wheel; a repeating cycle for 'Man' and 'Son' (Kodi Smit-McPhee), undertaking their pilgrimage on faith only assurance of a coastal Shangri-La. Head south. Try to find food. Try not to become food.
It does not take a genius to figure out The Road is a road movie. It is not a typical road movie, more like a chase movie in some respects, which becomes especially apparent during the final scene. Trawl movie might be a more apt description, though despite the journey being slow Hillcoat does not bloat the running time with drawn out vista pans; we get just quick flashes to feed our imagination – an abandoned truck in the middle of an overpass breathtaking in its meaning and simplicity.
Do not hold your breath for tidal waves or tornadoes. Following an unwarranted voiceover opening (strip it out and we lose nothing) the hint is that an environmental catastrophe has occurred. 'Has' being the optimum word. The story deals with aftershocks, literal and metaphorical. A forest of uprooting trees and the simple act of waking from a bad dream are used to exhilarating effect. Some of the jolts are blacker, brief but horrific, like the soon to be infamous basement full of ready to carve humans. You will be taken aback watching The Road. Infrequently perhaps, but you will be.
All of the characters in the film remain unnamed, except Robert Duvall's near blind geriatric, though he lies about his age (claims he is ninety) so who knows what else? His appearance is typically fleeting for a story that focuses solely on the two leads. Guy Pearce, The Wire's Michael Kenneth Williams, Duvall and Charlize Theron all walk in and out of the narrative with a lot to contribute but little to say or do. Every scene, character and person matters to the whole.
Viggo Mortensen is comfortably in the top ten most mesmerising actors of his generation. Both physically with his gaunt face and lithe body and in terms of the emotional commitment he brings to a role. His performance in The Road is up there with his best work. 'Man' even has shades of Mortensen's earlier role Lalin in Carlito's Way (1993), as someone whose hopelessness is palpable no matter how hard he tries to mask it.
Duvall, as usual, is perfect and should be in every other movie ever made. Theron bravely tackles an unsympathetic part much expanded from the book. And nobody cries like Kodi Smit-McPhee; his tears are heartbreaking.
Smit-McPhee's chemistry with Mortensen is moving, though not always convincing. Their dialogue would have benefited from trimming in those long nighttime exchanges, principally the 'fire inside' metaphor which despite best efforts; Mortensen in particular, fails to roll out of either actor's mouth with total assurance. The 'good guys' philosophy translates from the source material with far less sentimentality. Adhering to a moral code when there is no legal one left begs an interesting question: just how far would you go to survive?
Cormac McCarthy purists will sneer at the changes Hillcoat and screenwriter Joe Penhall have made. Charlize Theron's inflated backstory role and an absence of black ash on everything will doubtless be highest on their list of grievances. Yet Hillcoat's interpretation is as bleak as we could probably stand. He took it as far as he dared and created a beautiful suffering; crafting a film that somehow manages to be both unwatchable and unmissable at the same time.
The Road is released in the US on 25th November and UK 8th January 2010.
© 2009 – 2014, Lord Christopher Laverty.
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By Lord Christopher Laverty 1 Comment
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20 Nov '09 at 17:01
Creased or Folded? hecklerspray Tells You the Way it is | Hecklerspray