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 jag009 – NJ, 2016-04-12 18:24 (3375 d 22:04 ago) – Posting: # 16191
Views: 10,629

Hi,

Some hints:

IVIVC allows you to claim biowaiver for biostudy for SUPAC (manufacturing site transfer)
IVIVC is a great tool in formulation development, optimization.

Why not many IVIVC?

It's not easy to do unless your compound is BCS class 1 or 2.
Not many generic companies do manufacturing site transfers (?)

John

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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