A milestone schedule that includes dates for one or more of the following at the direction of the COR: Commencement of lab work Completion of lab work Completion of Draft Final report Commencement of QC review Commencement of QA review Submission of Draft Final report BMDV work described in Part 2.2 ff., cannot commence until COR-approval of the BSMP is received by the Contractor. Analysis Requirements At the direction of the COR, the Contractor shall perform the following biological sample development work. Method Development and Validation Method Development The Contractor shall develop a method to quantitate a chemical, test article, biotransformation products, and/or other specified substances (analyte) in a specified biological matrix. Control matrix used to develop the method shall be from adult male Sprague-Dawley rats, unless otherwise specified by the COR. Secondary matrices shall be incorporated into the method via matrix evaluations (see Section 2.3.6). The Contractor shall employ an analytical method suitable for small sample sizes (typically 100 µL for biofluids, typically plasma or whole blood, or 200 mg for tissues). The Contractor shall evaluate analytical methods available from the literature or other sources, including previously developed methods, to determine the lowest feasible concentration that may be measured.
A milestone schedule that includes dates for one or more of the following at the direction of the COR: Commencement of lab work Completion of lab work Completion of Draft Final report Commencement of QC review Commencement of QA review Submission of Draft Final report BMDV work described in Part 2.2 ff., cannot commence until COR-approval of the BSMP is received by the Contractor. Analysis Requirements At the direction of the COR, the Contractor shall perform the following biological sample development work. Method Development and Validation Method Development The Contractor shall develop a method to quantitate a chemical, test article, biotransformation products, and/or other specified substances (analyte) in a specified biological matrix. Control matrix used to develop the method shall be from adult male Sprague-Dawley rats, unless otherwise specified by the COR. Secondary matrices shall be incorporated into the method via matrix evaluations (see Section 2.3.6). The Contractor shall employ an analytical method suitable for small sample sizes (typically 100 µL for biofluids, typically plasma or whole blood, or 200 mg for tissues). The Contractor shall evaluate analytical methods available from the literature or other sources, including previously developed methods, to determine the lowest feasible concentration that may be measured.
biosamples20160811.docx