Log in
RegisterWhat about BCS II, (III), IV? [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2015-09-18 14:25 (3929 d 12:30 ago) – Posting: # 15429
Views: 8,981
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:
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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- In-vitro Dissolution complementary to BE sireen 2013-12-14 12:27 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- In vivo ≫ in vitro Shuanghe 2015-09-18 10:11
- In vivo ≫ in vitro Helmut 2015-09-17 12:41
- In vivo ≫ in vitro Erkin 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
Ing. Helmut Schütz