Bioequivalence and Bioavailability Forum • Sample size for Rabeprazole BE study

Sample size for Rabeprazole BE study [Design Issues]

posted by Dr Andrew Leary – Ireland, 2010-07-23 16:50 (5816 d 15:27 ago) – Posting: # 5666
Views: 11,436

Dear All

Any advances on this advice from 2007? I know the published BE studies are small, but see from the web that (a) according to Pharsight, rabeprazole has intra-subject CVs of 40% to 50%, and (b) Mylan used 72 subjects for their pivotal BE studies.

Regards to all

Andrew

Complete thread:

Sample size for Rabeprazole BE study Nirali 2007-11-22 08:10
- Rabeprazole not a HVD Helmut 2007-11-23 17:27
  - Rabeprazole a HVD Srinetram 2010-07-26 10:46
- Sample size for Rabeprazole BE study MGR 2007-11-26 06:47
  - Sample size for Rabeprazole BE studyDr Andrew Leary 2010-07-23 14:50
    - Sample size for Rabeprazole BE study Helmut 2010-07-24 14:05
    - Sample size for Rabeprazole BE study Pavidus 2010-07-26 08:06
      - Sample size for Rabeprazole BE study Dr Andrew Leary 2010-07-26 09:41
        
        Latin Helmut 2010-07-26 12:47
        
        Latin Dr Andrew Leary 2010-07-26 13:05
        
        Latin Helmut 2010-07-26 13:26
        Latin Pavidus 2010-07-26 15:41