Bioequivalence and Bioavailability Forum • Widened acceptance range w. a 2,2,2-study?

Widened acceptance range w. a 2,2,2-study? [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2011-10-09 15:44 (5377 d 12:48 ago) – Posting: # 7454
Views: 6,005

Hi all,

I noticed via this link that regulators seemingly -at least this is how I read it- accepted widened acceptance range for Cmax in study 065-08 (page 5 of the pdf) in a study that followed the basic standard 2,2,2-design.

The holy scripture reads:
"For the acceptance interval to be widened the bioequivalence study must be of a replicate design", so ElMaestro's walnut-sized brain cannot comprehend.

Is it a simple typo, a regulatory deviation from the guideline or do you read the PAR in a way that I don't?

Have a great day.
EM.

Complete thread:

Widened acceptance range w. a 2,2,2-study?ElMaestro 2011-10-09 13:44 [Regulatives / Guidelines]
- Widened acceptance range w. a 2,2,2-study? Helmut 2011-10-09 16:40
  - Widened acceptance range w. a 2,2,2-study? Dr_Dan 2011-10-10 12:01
    - Quot licet Iovi, non licet bovi Helmut 2011-10-10 12:57
      - Cmax of interest? Dr_Dan 2011-10-10 16:57
        
        CI outside 80.00%–125.00% Helmut 2011-10-10 18:23
        
        CI outside 80.00%–125.00%, who cares? Dr_Dan 2011-10-11 09:54
        
        Common sense rulez?! Helmut 2011-10-11 16:27