Bioequivalence and Bioavailability Forum

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

posted by Dr_Dan  – Germany, 2016-04-20 16:17 (3710 d 12:55 ago) – Posting: # 16222
Views: 11,551

Dear all
IVIVC = in-vitro in-vivo correlation, i.e. you need to have more than one set of clinical data. For generic products you need to demonstrate bioequivalence (= one set of clinical data). Therefore IVIVC is not applicable (provided that you do not fail several times in BE )
Kind regards
Dr_Dan

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