Bioequivalence and Bioavailability Forum • Questions about data manipulation

Questions about data manipulation [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2024-04-30 13:46 (167 d 18:03 ago) – Posting: # 23968
Views: 5,762

Hi QA,

❝ Is it advisable that CRO use this software (after implementing the SOP within the system) …

Yes, but…

❝ … and prove that no such manipulation was done during BE study.

Unfortunately you cannot prove that in the statistical sense (null hypothesis = no manipulation, alternative hypothesis = manipulation). The assessment contains still a subjective element. Sorry.

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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 manipulationHelmut 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
        
        OT Helmut 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