Bioequivalence and Bioavailability Forum

Imbalanced cross-overs [Study Performance]

posted by khaoula – Algeria, 2014-06-06 18:03 (4402 d 00:08 ago) – Posting: # 13039
Views: 22,518

Hi Helmut,

❝ I don’t understand what you mean here. The limit for HVDs/HVDPs is 30% CV of the reference obtained in a replicate design. CV_intra from a 2×2 serves only as a hint of a highly variable reference (since pooled from CV_WR and CV_WT).

this is a real study that was done in the institute were I do my post graduate disertation, and the drug is omeprazole, that is a HVDP (in bibliography I read a lot of bioequivalence stydy were CV > 30%) I know that the cross over isn't adapted for this, but CV C max of the study Was very low!!!!!!!!

Complete thread:

randomization khaoula 2014-06-06 14:04 [Study Performance]
- Imbalanced cross-overs Helmut 2014-06-06 14:47
  - Imbalanced cross-overskhaoula 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

Imbalanced cross-overs [Study Per­for­mance]

Complete thread:

Imbalanced cross-overs [Study Performance]