Bioequivalence and Bioavailability Forum • In vivo ≫ in vitro

In vivo ≫ in vitro [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-09-17 14:41 (3931 d 05:11 ago) – Posting: # 15417
Views: 9,143

Merhaba Erkin,

❝ But I don't understand is: we made a bioequivalence study and we found the products as bioequivalent.

Fine. End of story.

❝ After that why we bother about ƒ₂ unless sponsor wants to improve their product (and they need to do a new BE study afterall.)

I never bothered. IMHO, Appendix I 1.i is the most important part. It is highly unlikely that you ever find a discriminatory method for BCS classes II and IV (by definition). Even if you succeed, I would think that’s just a coincidence.

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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 vitroHelmut 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