Please guide me in below topics
- BA BE.
- Clinical Trial.
Please guide me in below topics
Multisource pharmaceutical products (generic or ANDA) need to conform to the same appropriate standards of quality, efficacy and safety as those required of the innovator’s (comparator) product called interchangeability so a generic medicinal product is supported by bioequivalence (BE) studies (in a few volunteers just to proof interchangeability) instead of full clinical trials for safety and efficacy which to be done in 3 phases for NDA products.
For more information take a look at the following guideline:
WHO- Annex 7 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability