FDA discusses additional topics in complex generics, complex injectables, ophthalmic, and otic products. Includes responses to audience in a question-and-answer panel. Presenters and presentations include:
Challenges in the Approval of Complex Otic and Ophthalmic Generic Products: Bioequivalence Perspectives
Chunsheng Zhao, PhD; DB III|OB|OGD|CDER
Challenges in the Approval of Complex Otic & Ophthalmic Generic Products: Quality Perspectives
Poonam Chopra, PhD; DLBP II|OLDP|OPQ|CDER
Physiological Based Pharmacokinetic Modeling and Simulation to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making
Mingliang Tan, PhD; DQMM|ORS|OGD|CDER
Q&A Panel (Including all above presenters):
Asif Rasheed, PhD; DLBPI|OLDP|OPQ|CDER
Kai Kwok, PhD; DLBPII|OLDP|OPQ|CDER
Yan Wang, PhD; DTP I|ORS|OGD|CDER
For slides and additional information: [ Ссылка ]
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