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Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

Автор: U.S. Food and Drug Administration

Загружено: 2020-03-30

Просмотров: 1237

Описание: Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Generic Drugs covers considerations related to the formulation of the test product. She also discusses bioequivalence (BE) approaches, considerations related to physical and structural (Q3) characterizations and the packaging configurations.

Learn more at https://www.fda.gov/drugs/cder-small-...


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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.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn:   / cder-small-business-and-industry-assistance  
Twitter:   / fda_drug_info  
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...

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Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019

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