Bioequivalence and Bioavailability Forum

In vivo ≫ in vitro [Regulatives / Guidelines]

posted by Erkin – Turkey, 2015-09-17 10:39 (3939 d 16:19 ago) – Posting: # 15414
Views: 9,322

Hallo Helmut,

Of course, not any in-vitro test simulates as best as the in-vivo does. But I don't understand is: we made a bioequivalence study and we found the products as bioequivalent. After that why we bother about f2 unless sponsor wants to improve their product (and they need to do a new BE study afterall.)

"An ƒ₂ value between 50 and 100 suggests that the two dissolution profiles are similar.
When the ƒ₂ statistic is not suitable, then the similarity may be compared using model-dependent or model-independent methods e.g. by statistical multivariate comparison of the parameters of the Weibull function or the percentage dissolved at different time points."

I think the key word is "MAY BE COMPARED".

Thank you very much Helmut .

Erkin Alkan

Complete thread:

• In-vitro Dissolution complementary to BE sireen 2013-12-14 12:27 [Regulatives / Guidelines] 
  • 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 vitroErkin 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