Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches скачать в хорошем качестве

Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches

Sam Raney from the Office of Generic Drugs discusses recent results from GDUFA-funded research into the influence of differences in the composition of topical products on the resulting dermal pharmacokinetics and bioavailability. The potential implications of these results for bioequivalence approaches (based on topical formulation “similarity” or “no difference”) will be explored. Learn more at https://www.fda.gov/drugs/regulatory-... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2020 Playlist -    • 2020 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cderbsbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367