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RegisterType-II Variation: Waive in-vivo study by providing in-vitro data? [Study Assessment]
Dear Helmut,
Thank you for the response.
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?
Regards,
QA
Thank you for the response.
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?
Regards,
QA
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