Drugs Stability Tests Seeking Approval from The FDA
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.)Specific stability tests that were ran (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-
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 of
Pharmaceuticals – A Compendium of Guidelines and Related Materials – Volume 1
