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Registermodel-based BE? [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2022-12-10 11:13 (176 d 13:50 ago) – Posting: # 23397
Views: 3,270
Hi Mittyri,
Perhaps. See this post refering to the EMA’s Methodology Working Party. Aren’t these points contradictory?
❝ FDA encourages generic and new drug applicants to propose and discuss novel methodologies (e.g., model-based BE…)
❝
❝ are you reading this as a projection of VBE or some broader successful trends exist?
Perhaps. See this post refering to the EMA’s Methodology Working Party. Aren’t these points contradictory?
- EMA does not exclude use of model informed BE, especially in cases when in vivo BE studies cannot be simply conducted in healthy subjects.
- When model-based BE is used, model evaluation should include technical and clinical validation of the model as well as assessment of its applicability.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
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- 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
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- 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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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 Bioequivalence Achievwin 2023-02-07 07:13
- A first look Helmut 2022-12-02 16:43
Ing. Helmut Schütz