In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT

Hiren Patel from the Office of Generic Drugs discusses In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT).
Patel highlights issues observed with IVRT and IVPT studies submitted in ANDAs to support bioequivalence of topical drug products. Patel discusses scientific challenges related to the development and validation of IVRT and IVPT methods along with data analysis. Practical considerations for the submission of detailed and well-organized information in ANDAs will be described.



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