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 ping4santosh – India, 2020-03-12 20:18 (1503 d 14:08 ago) – Posting: # 21260
Views: 2,993

Hi jag009,

AFAIK, it's upto the company to develop the disso profile and submit the data with acceptable range of F values.

If I have time over weekend, I will try to find references.

Cheers,
SKM

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 Indiaping4santosh 2020-03-12 19:18
  - Comp in-vitro disso studies for generics in India jag009 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