Bioequivalence and Bioavailability Forum • any non BE resulting from AUCs?

any non BE resulting from AUCs? [Power / Sample Size]

posted by yjlee168 – Kaohsiung, Taiwan, 2010-04-08 23:44 (5918 d 19:10 ago) – Posting: # 5055
Views: 6,540

Dear Helmut,

❝ As Bharat already pointed out, base your sample size

❝ estimation on the metric with the largest CV_intra.

❝ CV_intras are quite often ranked C_max > AUC_inf > AUC_t.

Completely agree with you. In regulatory aspect, we need to look at C_max, AUC_t & AUC_inf. However, in my experiences, all non BE cases mostly result from C_max. Have you seen any non BE because of AUC_t or AUC_inf in your experiences? Thanks.

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-- Yung-jin Lee
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Complete thread:

CV from previous study rasheed 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