Complex Generics: Topical Products, Part 1

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

“No Difference” Standard vs. Q1|Q2 Sameness for Topical Drug Products
Megan Kelchen, PhD; DTP I|ORS|OGD|CDER

Use of Q3 Characterization Tests for Topical Semisolid Drug Products
Sam Raney, PhD; IO|ORS|OGD|CDER

Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles
Ahmed Zidan, PhD; DPQR|OTR|OPQ|CDER

Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products
Eleftheria Tsakalozou, PhD; DQMM|ORS|OGD|CDER
Khondoker Alam, PhD; DQMM|ORS|OGD|CDER

Q&A Panel (Including all above presenters):
Markham Luke, MD, PhD; DTP I|ORS|OGD|CDER
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
 
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