Bioequivalence and Bioavailability Forum • OT

OT [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2024-05-01 22:42 (349 d 11:54 ago) – Posting: # 23973
Views: 7,302

Hi ElMaestro,

❝ […] And then we got guidance that was […] solving a hypothetical problem in such a way that it was all but impractical for an applicant to plan and dimension a study.

Reminds me on Individual / Population Bioequivalence, which was regarded* a

‘theoretical’ solution to a ‘thoretical’ problem.

BTW, at the GBHI-2024 in April I tried to squeeze information from the FDA’s participants about DABERS (Data Anomalies in BioEquivalence R Shiny). Nada.
Edit: Same at the SAAMnow Spring Workshop on Data Integrity in BE Studies in June.

Patterson S. A Review of the Development of Biostatistical Design and Analysis Techniques for Assessing In Vivo Bioequivalence: Part Two. Ind J Pharm Sci. 2001; 63(3): 169–86. Open Access.

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Complete thread:

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- Confirmed Ohlbe 2023-07-21 12:59
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  - Update Helmut 2024-03-22 20:29
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