Ke Ren from CDER Office of Generic Drugs’ Office of Bioequivalence III discusses inadequate studies from a regulatory perspective. She provides an overview of the regulatory criteria for in vivo bioequivalence (BE) studies, common BE deficiencies in pharmacokinetic (PK) studies, case studies on study design. She talks about how sampling time can be insufficient, washing out period insufficient to include the Tlag difference and scaling BE point estimate.
Learn more at [ Ссылка ]
_______________________________
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 [ Ссылка ] and [ Ссылка ] for news and a repository of training activities.
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: [ Ссылка ]
Twitter: [ Ссылка ]
CDER small business e-mail update subscription: [ Ссылка ]
![](https://i.ytimg.com/vi/65UnimhK_us/maxresdefault.jpg)