Bioequivalence and Bioavailability Forum

randomization [Study Performance]

posted by khaoula – Algeria, 2014-06-06 16:04 (3604 d 04:31 ago) – Posting: # 13037
Views: 18,213

Hi everybody , I have a question about impact of randomization in result of bioequivlence study:

we have design of bioequivalence study cross over design with 16 subject (randomised), but at the firt period the 15 suject didn't come, after we collected the results of 15 subjects and we analyzed Kinetica without protocol for the management of dropouts
we had abberants results: for Cmax CV = 0,03 % for hight variable drug, power: 50%, with subject effect and subject/sequence effect

if does not take into account the exclusion of subject N 15 have impact in the result of the study?

Complete thread:

randomizationkhaoula 2014-06-06 14:04
- Imbalanced cross-overs Helmut 2014-06-06 14:47
  - Imbalanced cross-overs khaoula 2014-06-06 16:03
    - CV 0.03%? Helmut 2014-06-07 13:52
    - Imbalanced cross-overs jag009 2014-06-09 15:36
      - Imbalanced cross-overs khaoula 2014-06-09 22:07
        
        Bag full of bugs Helmut 2014-06-10 00:37
        
        Randomisation? ElMaestro 2014-06-10 01:00
        
        Randomisation? Helmut 2014-06-10 14:53
        
        Randomisation? khaoula 2014-06-11 00:17
        
        Problems resolved? Helmut 2014-06-11 02:01
        
        Problems resolved? khaoula 2014-07-24 13:36
        
        corrected data in PHX/WNL Helmut 2014-07-27 01:37
        
        Which version of Kinetica? Helmut 2014-06-11 19:51
        
        Which version of Kinetica? khaoula 2014-06-12 00:41
        Which version of Kinetica? khaoula 2014-07-25 00:49
        
        adjusted means (aka LSMs) Helmut 2014-07-27 02:23
        
        adjusted means (aka LSMs) khaoula 2014-08-25 21:41

randomization [Study Per­for­mance]

Complete thread:

randomization [Study Performance]