New Drugs Stability Tests Seeking Approval from The FDA

Please use the reference materials provided in this document along with trusted online resources. These references will provide you with a general understanding of stability testing and the reason of its key importance related to the overall drug development process. Choosing the API you used in Written Assignments 1 & 2 please complete a 7 pages paper that provides 1.) a summaryofstabilitytestingforthecompoundyouchose.2.)Specificstabilityteststhatwereran (if you can find specific report numbers that would be great) for the compound you selected. 3.) Provide a brief background on the Company/Sponsor that ran the tests (remember, the sponsor does not always run the tests, it could be a separate facility that ran the test) including their historywithinthespaceforthespecifictherapeuticareayouareworkingin.4.)Includeatleast

2-3 tables, graphs or figures supporting the stability data with clear understanding of its purpose. The tables can be your own and/or referenced via a finalized stability report.

Please do not count graph and tables in 7 pages.

MATERIALS

Stability Testing of New Drug Substances and Products

HTTP://WWW.ICH.ORG/PRODUCTS/GUIDELINES/QUALITY/QUALITY-SINGLE/ARTICLE/STABILITY-TESTING-OF-NEW-DRUG-

SUBSTANCES-AND-PRODUCTS.HTML

Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073369.pdf

World Health Organization: Quality Assurance ofPharmaceuticals – A Compendium of Guidelines and Related Materials – Volume 1

http://apps.who.int/medicinedocs/en/d/Jh1813e/3.3.3.html