Difference between BA BE & Clinical Trials

(Dattu Wadekar) #1

Please guide me in below topics

  1. BA BE.
  2. Clinical Trial.
(ussidaho) #2

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