HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATAN Programme code : MPHAQ Programme Name : MPHARM Course Code MPHAQ101CE Semester : 1 BIOLOGICAL EVALUATIONS AND CLINICAL RESEARCH THEORY (BCT) Course type : Core Elective Total Credit : 04 Teaching time Examination Marking scheme (hours) Theory Practical Internal External Total (hrs) (hrs) (Marks) (Marks) (Marks) 4 X 15 = 60 30 70 ( of 3 hrs) 100 Unit Topic Content Hrs. Marks Credit No. No W +% 1 1.1 Biological Standardization: General Principles, 6 Scope & limitations of Bioassays. Bio- assays of some Official Drugs. 2 Sterility Tests: Methodology & Interpretation 6 3 Pyrogen: Chemistry and properties of bacterial 6 pyrogens and endotoxins. Mechanisms of action of pyrogens. Pharmaceutical aspects, pyrogen test of IP compared to that of BP & USP. Interpretation of data, Comparison of LAL and other pyrogen tests. 4 Analysis of drugs from biological samples including, 6 selection of biological sample, extraction of drugs by various methods as LLE, SPE and Membrane filtration. 5 Microbiological Tests, Tests for effectiveness of 6 antimicrobial preservatives 6 Preclinical Drug Evaluation, acute, sub acute and 10 chronic toxicity studies, LD50 & ED50 determination, evaluation of compound for its biological activity, study of special toxicities like teratogenicity and mutagenicity. 7 Bio-analytical Method Development 5 8 Good Clinical Practices. 5
HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATAN Programme code : MPHAQ Programme Name : MPHARM Course Code MPHAQ101CE Semester : 1 BIOLOGICAL EVALUATIONS AND CLINICAL RESEARCH THEORY (BCT) Course type : Core Elective Total Credit : 04 Teaching time (hours) Examination Marking scheme Theory (hrs) Practical (hrs) Internal (Marks) External (Marks) Total (Marks) 4 X 15 = 60 30 70 ( of 3 hrs) 100 Unit No. Topic No Content Hrs. Marks W +% Credit 1 1.1 Biological Standardization: General Principles, Scope & limitations of Bioassays. Bio- assays of some Official Drugs. 6 2 Sterility Tests: Methodology & Interpretation 6 3 Pyrogen: Chemistry and properties of bacterial pyrogens and endotoxins. Mechanisms of action of pyrogens. Pharmaceutical aspects, pyrogen test of IP compared to that of BP & USP. Interpretation of data, Comparison of LAL and other pyrogen tests. 6 4 Analysis of drugs from biological samples including, selection of biological sample, extraction of drugs by various methods as LLE, SPE and Membrane filtration. 6 5 Microbiological Tests, Tests for effectiveness of antimicrobial preservatives 6 6 Preclinical Drug Evaluation, acute, sub acute and chronic toxicity studies, LD50 & ED50 determination, evaluation of compound for its biological activity, study of special toxicities like teratogenicity and mutagenicity. 10 7 Bio-analytical Method Development 5 8 Good Clinical Practices. 5