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Registermodel-based BE? [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2022-12-10 11:13 (860 d 12:40 ago) – Posting: # 23397
Views: 9,121
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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- model-based BE?Helmut 2022-12-10 10:13
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Ing. Helmut Schütz