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Complex Generics: Topical Products, Part 2

FDA discusses additional topics in complex generic topical products. Includes responses to audience in a question-and-answer panel. Presenters and presentations include:

Common Issues Identified in In-vitro Release Test (IVRT) and In-vitro Permeation Test (IVPT) Studies Submitted in ANDA to Support Bioequivalence for Topical Products
Josephine Aimiuwu, PhD; DB II|OB|OGD|CDER

Theoretical Principles and Best Practices: In Vitro Release Test
Tannaz Ramezanli, PhD, PharmD; DTP I|ORS|OGD|CDER

Theoretical Principles and Best Practices: In Vitro Permeation Test
Priyanka Ghosh, PhD; DTP I|ORS|OGD|CDER

Q&A Panel (Including all above presenters):
Markham Luke, MD, PhD; DTP I|ORS|OGD|CDER
Sam Raney, PhD; IO|ORS|OGD|CDER
For slides and additional information: https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-09212021-09222021
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