Bioequivalence and Bioavailability Forum • What is the point of IVIVCs for generics?

What is the point of IVIVCs for generics? [Dissolution / BCS / IVIVC]

posted by luvblooms – India, 2016-04-19 18:43 (3716 d 08:16 ago) – Posting: # 16221
Views: 11,595

Hi John,

❝ Some hints:

❝ 1. IVIVC allows you to claim biowaiver for biostudy for SUPAC (manufacturing site transfer)

❝ 2. IVIVC is a great tool in formulation development, optimization.

❝ Why not many IVIVC?

IVIVC has also been used to

set the dissolution specification during development
to modify dissolution specification during stability (been there, done that and got approval on the changed specification setting )

Regards

—
~A happy Soul~

Complete thread:

What is the point of IVIVCs for generics? CLR 2016-04-11 10:12
- What is the point of IVIVCs for generics? jag009 2016-04-12 16:24
  - What is the point of IVIVCs for generics? CLR 2016-04-19 05:29
  - What is the point of IVIVCs for generics?luvblooms 2016-04-19 16:43
    - What is the point of IVIVCs for generics? Dr_Dan 2016-04-20 14:17
      - Education needed Helmut 2016-04-20 16:04
      - What is the point of IVIVCs for generics? jag009 2016-04-20 21:29
        
        What is the point of IVIVCs for generics? Dr_Dan 2016-04-21 08:35

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