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RegisterType-II Variation: Waive in-vivo study by providing in-vitro data? [Study Assessment]
Dear QA
BCS based biowaivers for class III products are possible according to the ICH M9 guideline which has already reached Step 5 in Europe (i.e. has been implemented).
However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity.
❝ Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size?
BCS based biowaivers for class III products are possible according to the ICH M9 guideline which has already reached Step 5 in Europe (i.e. has been implemented).
However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity.
Complete thread:
- Decrease in PSD: Need to repeat BE? qualityassurance 2024-07-02 08:32
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Type-II Variation Helmut 2024-07-02 09:37
- Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
- Type-II Variation: Waive in-vivo study by providing in-vitro data?SMA 2024-07-02 16:27
- Type-II Variation: Waive in-vivo study by providing in-vitro data? Relaxation 2024-07-04 12:19
- Type-II Variation: Waive in-vivo study by providing in-vitro data?SMA 2024-07-02 16:27
- Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
- Type-II Variation Helmut 2024-07-02 09:37
Ing. Helmut Schütz