Bioequivalence and Bioavailability Forum • Consistency

Consistency [Two-Stage / GS Designs]

posted by DavidManteigas – Portugal, 2016-10-11 13:25 (2746 d 18:18 ago) – Posting: # 16721
Views: 12,544

Hi all,

I get shocked sometimes with the lack of consistency in assessments of member states which should all follow the same guidelines and made their reviews according to the current opinions of the scientific groups of the EMA. I think this happens due to lack of training in regulatory reviews and "regulatory science" in general (in Portugal, almost all of the reviewers I know are "academic") and also due to lack of resources in some agencies to have qualified reviewers for each 'specialty'.
In some countries, I believe that as long as you got a favourable opinion from an ethics committee and regulatory approval for the trial, they will consider your trial "valid" regardless of the appopriateness of the design, statistical methodology and compliance with guidelines/recommendations for design & analysis.

Complete thread:

Replicated 4×2 and two-stage-design, in the same protocol Mauricio Sampaio 2015-04-06 08:37
- Replicated 4×2 and two-stage-design, in the same protocol ElMaestro 2015-04-06 08:53
- Science fiction Helmut 2015-04-06 14:20
  - Science fiction Dr_Dan 2016-03-04 10:33
    - Science fiction furthermore d_labes 2016-03-04 13:21
    - Still SF Helmut 2016-03-04 13:41
      - Still SF VStus 2016-10-06 21:08
        
        Still SF ElMaestro 2016-10-06 22:13
        
        Still SF VStus 2016-10-06 22:53
        Still SF VStus 2016-10-11 10:23
        
        Still SF Helmut 2016-10-07 10:38
        
        Still SF VStus 2016-10-11 09:10
- mindblowing ElMaestro 2016-10-11 07:44
  - Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50
    - ConsistencyDavidManteigas 2016-10-11 11:25