Bioequivalence and Bioavailability Forum • CV from previous study

CV from previous study [Power / Sample Size]

posted by rasheed – 2010-04-08 10:53 (5927 d 22:24 ago) – Posting: # 5034
Views: 7,856

It is recommended by the FDA that we can use coefficient of variance (CV) from previous study to calculate the smaple size for the new study, but I cant understand that which PK parameter (AUC(0-t), AUC(0-inf), Cmax) is used from previous study for the sample size of the new study? because I encountered large difference between CV's for AUC and Cmax from previous study.

Edit: Please see the Policy. [Helmut]

Complete thread:

CV from previous studyrasheed 2010-04-08 08:53
- CV from previous study bharat 2010-04-08 13:57
  - CV nick name d_labes 2010-04-08 14:23
    - CV nick name(s) Helmut 2010-04-08 14:55
- Sample size based on largest CV for AR Helmut 2010-04-08 15:34
  - any non BE resulting from AUCs? yjlee168 2010-04-08 21:44
    - non BE resulting from AUCs: rarely Helmut 2010-04-08 23:48