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RegisterVirtual Bioequivalence: an update from PAGE (+TSD!) [Dissolution / BCS / IVIVC]
Dear All!
here's the update from the latest PAGE meeting:
here's the update from the latest PAGE meeting:
- Model-based approach for group sequential and adaptive designs in parallel and cross-over bioequivalence studies
AFAIK this one is the most interesting. Authors are INSERM and FDA people. But it looks like their adaptive design cannot control TIE. How come?
- Selection of optimal study design based on the bioequivalence simulation study in highly variable drugs
- An In Vitro – In Vivo Simulation Methodology for Predicting the Outcome of Bioequivalence Studies
- Investigation of the impact of population parameters describing gastric emptying on bioequivalence metrics
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Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Virtual Bioequivalence: a myth or coming reality? mittyri 2018-06-09 22:39 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Virtual Bioequivalence: a myth or coming reality? jag009 2018-06-13 02:40
- Virtual Bioequivalence: a myth or coming reality? elba.romero 2018-10-19 01:17
- Virtual Bioequivalence: an update from PAGE (+TSD!)mittyri 2019-06-21 13:50
- FDA not concerned about the type I error? Helmut 2019-06-22 18:11
- Virtual Bioequivalence: a myth or coming reality? Helmut 2021-12-23 22:31
- Synovia is a nasty beast mittyri 2021-12-24 13:23
- Synovia is a nasty beast dshah 2022-01-10 15:31
- Synovia is a nasty beast mittyri 2021-12-24 13:23
- Virtual Bioequivalence: a myth or coming reality? Helmut 2022-02-17 12:06
Ing. Helmut Schütz