Bioequivalence and Bioavailability Forum • AUC infinity

AUC infinity [PK / PD]

posted by Ohlbe – France, 2010-01-13 12:35 (5639 d 19:07 ago) – Posting: # 4592
Views: 8,290

Dear Ram,

❝ Is it important to show AUCinfinity within range of 80-125% for Bioequivalence,

For which country are you conducting this study ?

❝ shall I exclude AUCinfinity from Bioequivalence if power is around 50 % and other PK parameter like Cmax and AUClast are within 80-125% and AUCinfinity is out of range ?

Whatever you do should be pre-defined in your protocol, not decided based on the results of the study.

Regards
Ohlbe

Complete thread:

AUC infinity kram 2010-01-13 11:06 [PK / PD]
- AUC infinityOhlbe 2010-01-13 11:35
  - AUC infinity kram 2010-01-13 13:15
    - EMA vs. FDA Ohlbe 2010-01-13 17:36
- A posteriori power Helmut 2010-01-13 14:23