Bioequivalence and Bioavailability Forum • Another two...

Another two... [GxP / QC / QA]

posted by Ohlbe – France, 2021-09-16 23:41 (373 d 01:02 ago) – Posting: # 22575
Views: 4,056

Dear all,

It looks like the FDA has just keelhauled 2 CROs again: Panexcell and Synchron Research. The FDA will reject all data from both CROs due to data manipulation. All Panexcell data had already been rejected in the EU.

The FDA letters are very explicit regarding what they have found, and their conclusion is crystal clear:

Put simply, because you have been responsible for the creation of false data in the studies discussed here, we have no reason to believe that any data that you have produced are reliable. Thus, FDA has determined that all study data from all studies conducted at your firm must be rejected.

—
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 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