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 summary of stabilitytesting for the compound youchose.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.
Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products
World Health Organization: Quality Assurance ofPharmaceuticals – A Compendium of Guidelines and Related Materials – Volume 1