Bioequivalence and Bioavailability Forum • I still think that T/R-ratios are useful

I still think that T/R-ratios are useful [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2022-05-25 14:04 (873 d 19:23 ago) – Posting: # 23019
Views: 5,657

Dear Ohlbe,

❝ 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. ;-)

❝ … the whistleblower said that "the switch", as ElMaestro calls it, was done only for some sponsors, who paid the head of the bioanalytical lab to do it. The report does not mention any evidence being found to support this allegation, but that's indeed a possibility.

However, as I wrote above it’s a pretty trivial exercise for anybody to critically inspect the data. No need to buy a pig in a poke.

An example from my files: 2×2×2 crossover of a HVD back in the day when reference-scaling was not acceptable, assumed T/R-ratio 95%, CV 40%, targeted at ≥80% power, anticipated dropout-rate 10%. Hence, the large sample size (74 dosed). In the study (71 eligible subjects) the PE was with 96.77% slightly better than expected (90% CI: 89.82–104.26%) and the CV with 27.1% as well.

[image]
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?«
(With a sigh, the statistician types cmd ⏎ rmdir "C:\Users\Genius" /s /q ⏎
and tries to become a regulator or an academic…)

❝ – if the sponsor selected the CRO precisely because it is doing "the switch" (be the decision to select that CRO or to make "the switch" made by the Man in the Penguin Armani Suit or by somebody not willing to bring bad news to this man), well...

Likely he receives annual gratifications cause all studies pass. If sumfink is uncovered, he moves to the next company.
Nowadays being employed by numerous companies is understood as sign of competence and ‘solution based flexibility’. ~~Boomers~~ Dinosaurs who stayed for decades in the same company are on their way to retire.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 usefulHelmut 2022-05-25 12:04
        
        T/R-ratios are useful Ohlbe 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