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RegisterIn-vitro Dissolution: Order and questions [Regulatives / Guidelines]
Hi Sireen, Dr_Dan and Helmut!
I would continue this discussion.
According to the chapter 4.2.2
"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."
Do I understand correct the order:
(Our preceding GL states that we could use 6 units only. Now we use EMA GL.)
Is there no need for additional dissolution tests of different strengths of reference product (no need to compare other Reference Batches to the Test Batches)?
What could we do if information is published (not from Originator) about instability of the active substance in one of ph media? Should we check it or refer to the source only?
I would continue this discussion.
According to the chapter 4.2.2
"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."
Do I understand correct the order:
- to perform dissolution tests at three different buffers for the BEQ batches of test and reference
- to perform dissolution tests at three different buffers for BEQ batch (test) and all additional strengths of test product
(Linearity of PK is proven)
(Our preceding GL states that we could use 6 units only. Now we use EMA GL.)
Is there no need for additional dissolution tests of different strengths of reference product (no need to compare other Reference Batches to the Test Batches)?
What could we do if information is published (not from Originator) about instability of the active substance in one of ph media? Should we check it or refer to the source only?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
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 questionsmittyri 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 questionsmittyri 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