Bioequivalence and Bioavailability Forum

What about BCS II, (III), IV? [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2015-09-18 14:25 (3933 d 18:39 ago) – Posting: # 15429
Views: 9,008

Hi Shuanghe & all,

of course you are perfectly right.

One should always try to develop a suitable in vitro method.
However, I have some doubts whether matching profiles (ƒ₂, Mahalanobis distance, what­so­ever) for BCS classes II, IV (and III except weak acids; qualitatively/quantitatively iden­ti­cal excipients) could ever be of any re­le­vance for the in vivo performance. I wonder whether someone got a response from an agency like this:

Bioequivalence between the formulation applied for and the brand leader product has been demonstrated in vivo and similarity of dissolution profiles could be de­mon­strated in vitro. However, the drug does not belong to BCS Class I; as a con­sequence if any future changes in the formulation are proposed the com­pa­ri­son of dissolution profiles cannot be used as similarity of formulations and new bio­equi­va­lence studies have to be carried out.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• In-vitro Dissolution complementary to BE sireen 2013-12-14 12:27 
  • In-vitro Dissolution complementary to BE Dr_Dan 2013-12-16 12:58
    • In-vitro Dissolution complementary to BE Helmut 2013-12-16 14:50
      • In-vitro Dissolution: Order and questions mittyri 2014-01-22 19:39
        • In-vitro Dissolution: Order and questions Dr_Dan 2014-01-23 11:50
        • In-vitro Dissolution: Order and questions Erkin 2015-09-16 11:24
          • In vivo ≫ in vitro Helmut 2015-09-16 15:37
            • In vivo ≫ in vitro Erkin 2015-09-17 08:39
              • In vivo ≫ in vitro Helmut 2015-09-17 12:41
                • In vivo ≫ in vitro Shuanghe 2015-09-18 10:11
                  • What about BCS II, (III), IV?Helmut 2015-09-18 12:25