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, 2020-03-15 00:20 (1941 d 03:00 ago) – Posting: # 21270
Views: 4,493

Hello Jag,

I know the US rules but not if it's the same as in India...

Please let us know the US rules.

Lastly, is there a requirment on what kind of testings...

You need to show the disso profile in different medias with different pH mimicking the various zones of bio absorption. It again depends on the BCS classification of the product and the use of solublizers. It will be helpful if you post your understanding of US rules so that I would know where to guide you.

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 India ping4santosh 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 Indiaping4santosh 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