Bioequivalence and Bioavailability Forum • T/R-ratios are useful

T/R-ratios are useful [GxP / QC / QA]

posted by Ohlbe – France, 2022-05-25 16:40 (700 d 03:03 ago) – Posting: # 23020
Views: 3,887

Dear Helmut,

❝ ❝ Well, remember GVK ? According to the ANSM inspection report (document A3, page 3), …

❝ Didn’t know that the documents are in the public domain in the meantime. ;-)

I found them by chance, linked to this paper and that one from the same author. Apparently he made a freedom-of-information request and posted the reports he obtained.

❝ However, as I wrote above it’s a pretty trivial exercise for anybody to critically inspect the data.

"Trivial" if you have the coding skills or know someone who does, yes, definitely. And yes, it definitely makes sense, even (especially ?) if you are buying a dossier from the shelf.

❝ Possibly the statistician was fired by the man in the Armani suit shouting

❝ »You’re a bloody looser‼ Why didn’t we perform the study in 16 subjects‽

❝ I calculated post hoc power in FARTSSIE and it’s already 81.6%! What’s the point of having 99.4% at the end?«

Come on, the man in the Armani suit has no idea how to use FARTSSIE and has even never heard of it :-D

—
Regards
Ohlbe

Complete thread:

Another two... Ohlbe 2021-09-16 23:41 [GxP / QC / QA]
- Another two... ElMaestro 2021-09-17 08:42
  - Dates Ohlbe 2021-09-17 10:15
  - Some more info Ohlbe 2021-09-17 20:28
    - EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
  - Increased variability Ohlbe 2021-09-17 17:56
    - Increased variability ElMaestro 2021-09-17 18:51
      - Visualization Helmut 2021-09-18 15:26
- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
  - Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
    - Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
      - Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
    - Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
      - (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
        
        Sponsors and CRO selection Ohlbe 2022-05-25 10:53
        
        I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
        
        T/R-ratios are usefulOhlbe 2022-05-25 14:40
        
        T/R-ratios are useful Helmut 2022-05-25 15:35
        Bust the Buster Helmut 2022-05-26 15:32
        
        complicate the assessor's life mittyri 2022-05-26 18:28
        
        complicate the assessor's life PharmCat 2022-05-27 09:57
        complicate the assessor's life Helmut 2022-05-27 10:11
        
        Thanks for Busting the Buster sameep 2022-05-31 08:34
        
        Thanks for Busting the Buster Helmut 2022-05-31 15:22
        
        A small point for the code sameep 2022-06-01 13:17
        
        A small point for the code Helmut 2022-06-01 14:11