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, 2016-04-20 23:29 (3717 d 13:06 ago) – Posting: # 16228
Views: 11,475

Hi Dr. Dan,

IVIVC is applicable for a generic company in terms formulation development, post pilot bio-study formulation optimization (ie: if established, the model allows you to predict a target disso profile which can result in a product BE to reference).

Of course then you have specification, site transfer, stability, yada yada...

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