Bioequivalence and Bioavailability Forum • ANVISA: 90% CI for AUCINF in 72hrs truncated BE Study

ANVISA: 90% CI for AUCINF in 72hrs truncated BE Study [Regulatives / Guidelines]

posted by Nirali – India, 2007-09-21 08:26 (6480 d 09:51 ago) – Posting: # 1104
Views: 6,597

Dear Group Members,

Is calculation of 90%CI required for AUCINF while doing ANVISA submission for 72hrs truncated single dose, crossover BE study?

Product has long half life-70hrs. Therefore planned to truncate AUC upto 72hrs. ANVISA guideline has not clearly mentioned that 90%CI for AUCINF is required or not, for the same.

Would you pls explain the importance of AUCINF in 72hrs-truncated BE study?

Thanks & Regards,
Nirali

Complete thread:

ANVISA: 90% CI for AUCINF in 72hrs truncated BE StudyNirali 2007-09-21 06:26 [Regulatives / Guidelines]
- ANVISA: truncated AUC Helmut 2007-09-21 13:26
  - ANVISA: truncated AUC Nirali 2007-09-22 17:53
  - sampling time points for truncated AUC Nirali 2007-09-25 07:29
    - sampling time points for truncated AUC Helmut 2007-09-25 13:33
      - sampling time points for truncated AUC Purav 2007-09-27 06:35
        
        sampling time points for truncated AUC Ohlbe 2007-09-27 10:25