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

posted by jag009  – NJ, 2016-04-12 18:24 (3230 d 18:23 ago) – Posting: # 16191
Views: 10,264

Hi,

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

John

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