Bioequivalence and Bioavailability Forum • Evaluation of Reference variability

Evaluation of Reference variability [Design Issues]

posted by Ohlbe – France, 2009-04-17 12:04 (5480 d 00:58 ago) – Posting: # 3553
Views: 2,946

Dear Nirali,

❝ Shall it be appropriate design to evaluate reference variability for EU regulatory? :confused:

This was not the approach recommended at the EGA meeting last October. The preferred approach was to have a 3- or 4-period replicate study, with the reference administered twice, and the test once or twice. It seems that they are afraid that you might run a messy trial to show a high variability with the reference alone, and use these results to justify wider acceptance limits in a clean 2x2 trial with test and reference afterwards.

Regards
Ohlbe

Complete thread:

Evaluation of Reference variability Nirali 2009-04-13 11:53 [Design Issues]
- Evaluation of Reference variability KR 2009-04-13 14:39
- Evaluation of Reference variability Ravi 2009-04-14 06:25
  - Evaluation of Reference variability Nirali 2009-04-17 07:38
    - Evaluation of Reference variabilityOhlbe 2009-04-17 10:04
    - Evaluation of Reference variability Helmut 2009-04-17 13:44
      - Evaluation of Reference variability Nirali 2009-04-18 09:04
        
        Evaluation of Reference variability Helmut 2009-04-18 12:31
        
        Evaluation of Reference variability Nirali 2009-04-18 19:34
      - Evaluation of Reference variability Marcel 2010-03-16 13:10
        
        Evaluation of Reference variability Helmut 2010-03-16 16:01
        
        Evaluation of Reference variability ElMaestro 2010-03-16 17:13
        
        Some desultory thoughts Helmut 2010-03-16 18:59
        
        Evaluation of Reference variability Marcel 2010-03-17 12:47