OT [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-05-01 22:42 (47 d 20:02 ago) – Posting: # 23973
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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.



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