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RegisterWebinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence [BE/BA News]
Wishful thinking: I hope they give clear direction (kill once for all) - the annoying center/group effect portion for BE studies conducted in one country and in homogenous population.
As many times and on many platforms they mentioned it is irrelevant in BE/ANDA contecxt some academic curiosity folks keep brining this topic and keep the topic alive.
As many times and on many platforms they mentioned it is irrelevant in BE/ANDA contecxt some academic curiosity folks keep brining this topic and keep the topic alive.
❝ FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
Complete thread:
- New guidance on Statistical Approaches to Establishing Bioequivalence Relaxation 2022-12-02 15:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- A first look Helmut 2022-12-02 16:43
- A first look jag009 2022-12-02 17:58
- A first look BRB 2022-12-02 18:20
- SAS strikes back mittyri 2022-12-02 20:38
- SAS strikes back Helmut 2022-12-02 22:30
- Outliers? mittyri 2022-12-02 22:52
- Outliers? Helmut 2022-12-02 23:11
- SAS strikes back Achievwin 2023-02-07 07:23
- Outliers? mittyri 2022-12-02 22:52
- SAS strikes back Helmut 2022-12-02 22:30
- model-based BE? mittyri 2022-12-07 16:26
- model-based BE? Helmut 2022-12-10 10:13
- Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
- model-based BE? SMA 2023-01-17 09:41
- model-based BE? Helmut 2022-12-10 10:13
- A first look PharmCat 2022-12-21 19:30
- A first look Rayhope 2023-01-06 06:56
- A first look jag009 2022-12-02 17:58
- Groups, sites… Helmut 2022-12-03 13:09
- SxF ElMaestro 2022-12-04 06:34
- SxF Helmut 2022-12-10 10:37
- New guidance on Statistical Approaches to Establishing Bioequivalence Mahmoud 2022-12-10 14:08
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing BioequivalenceAchievwin 2023-02-07 07:13
- Multi-group studies ad nauseam Helmut 2023-02-07 11:30
- Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
- Webinar: Recording available Helmut 2023-04-01 10:38
- Multi-group studies ad nauseam Helmut 2023-02-07 11:30
- Speed kills Helmut 2023-02-07 13:02
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing BioequivalenceAchievwin 2023-02-07 07:13
- A first look Helmut 2022-12-02 16:43
Ing. Helmut Schütz