In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B скачать в хорошем качестве

In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B

Presentations and a panel discuss the design, conduct, and data analysis of in vivo bioequivalence studies, including the study design and the selection of appropriate subject or patient populations, for certain complex products, including oncologic products. Presentations include, “Complexities Involved in Conducting Patient Pharmacokinetic/Pharmacodynamic/Clinical Endpoint Studies and Alternate Proposals to Have Simplified Study Designs” and “Clinical Development of Orally Inhaled Products: Bioequivalence Study Designs, Conduct, Subject Attributes and Analysis - Challenges and Opportunities.” Learn more at: https://www.fda.gov/drugs/news-events... _______________________________  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 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367