Bioequivalence and Bioavailability Forum • Comp in-vitro disso studies for generics in India

Comp in-vitro disso studies for generics in India [Dissolution / BCS / IVIVC]

posted by jag009 – NJ, 2020-03-13 18:34 (1498 d 06:40 ago) – Posting: # 21268
Views: 2,940

Thank you ping4santosh. Lastly, is there a requirment on what kind of testings need to be done on the reference product (i.e, potenty or total assay, any others)? I know the US rules but not if it's the same as in India.

Thanks
J

Complete thread:

Comp in-vitro disso studies for generics in India jag009 2020-03-12 15:41
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-12 19:18
  - Comp in-vitro disso studies for generics in Indiajag009 2020-03-13 17:34
    - Comp in-vitro disso studies for generics in India ping4santosh 2020-03-14 23:20
      - Comp in-vitro disso studies for generics in India jag009 2020-03-15 07:25
        
        Comp in-vitro disso studies for generics in India ping4santosh 2020-03-15 10:05