Bioequivalence and Bioavailability Forum • OT

OT [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2024-05-01 22:42 (222 d 06:37 ago) – Posting: # 23973
Views: 5,998

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:

Another one? Helmut 2023-07-19 09:04 [GxP / QC / QA]
- Confirmed Ohlbe 2023-07-21 12:59
  - Who cares? Helmut 2023-07-21 14:24
    - Who cares? Ohlbe 2023-07-21 14:39
      - Expert Helmut 2023-07-21 14:41
  - Questions about data manipulation mittyri 2023-07-22 19:57
    - Data manipulation Ohlbe 2023-07-22 20:47
    - Questions about data manipulation wienui 2023-07-23 17:29
      - Questions about data manipulation qualityassurance 2024-04-30 11:38
        
        Questions about data manipulation Helmut 2024-04-30 11:46
        
        Questions about data manipulation qualityassurance 2024-04-30 13:55
        
        Questions about data manipulation Helmut 2024-04-30 14:52
        
        Assessment report published Ohlbe 2024-06-05 12:45
        
        Questions about data manipulation Ohlbe 2024-04-30 18:25
        
        Questions about data manipulation ElMaestro 2024-05-01 07:10
        
        OTHelmut 2024-05-01 20:42
        Questions about data manipulation Ohlbe 2024-05-01 20:58
  - Update Helmut 2024-03-22 20:29
    - Health Canada recalls Helmut 2024-06-09 09:16
    - And the FDA… Helmut 2024-06-19 11:22
- Another one? Ajay Gupta 2023-07-24 04:19