In vivo ≫ in vitro [Regulatives / Guidelines]
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
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
- In vivo ≫ in vitro Shuanghe 2015-09-18 10:11
- In vivo ≫ in vitro Helmut 2015-09-17 12:41
- In vivo ≫ in vitroErkin 2015-09-17 08:39
- In vivo ≫ in vitro Helmut 2015-09-16 15:37
- In-vitro Dissolution: Order and questions mittyri 2014-01-22 19:39
- In-vitro Dissolution complementary to BE Helmut 2013-12-16 14:50
- In-vitro Dissolution complementary to BE Dr_Dan 2013-12-16 12:58