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RegisterIn-vitro Dissolution complementary to BE [Regulatives / Guidelines]
Dear members,
Probably this is an old issue for most of you... The EMEA guideline on the investigation of BE states that "Similarity of in vitro dissolution should be demonstrated at all conditions within the applied product series, i.e. between additional strengths and the strength(s) (i.e. batch(es)) used for bioequivalence testing."... What about the QC dissolution method.... what I mean to ask is: would an in-vitro dissolution in SGF media, reflect bioequivalency if the three different buffers (pH 1.2, 4.5 and 6.8) demonstrated otherwise.
Also, some lectures state to conduct in-vitro dissolution profiles under similar conditions... does that mean within a certain period of time... can't I compare my current data against results from 2 years ago... Would that raise questions by regulatory authorities.
Apologies if such questions are depressingly not challenging for you, nevertheless, thank you for your comments...
Sireen
Probably this is an old issue for most of you... The EMEA guideline on the investigation of BE states that "Similarity of in vitro dissolution should be demonstrated at all conditions within the applied product series, i.e. between additional strengths and the strength(s) (i.e. batch(es)) used for bioequivalence testing."... What about the QC dissolution method.... what I mean to ask is: would an in-vitro dissolution in SGF media, reflect bioequivalency if the three different buffers (pH 1.2, 4.5 and 6.8) demonstrated otherwise.
Also, some lectures state to conduct in-vitro dissolution profiles under similar conditions... does that mean within a certain period of time... can't I compare my current data against results from 2 years ago... Would that raise questions by regulatory authorities.
Apologies if such questions are depressingly not challenging for you, nevertheless, thank you for your comments...
Sireen
Complete thread:
- In-vitro Dissolution complementary to BEsireen 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