Bioequivalence and Bioavailability Forum • Model bioequivalence data summary tables-FDA

Model bioequivalence data summary tables-FDA [RSABE / ABEL]

posted by kumarnaidu – Mumbai, India, 2014-08-20 09:04 (4330 d 09:11 ago) – Posting: # 13410
Views: 11,241

Hello every one,

I have one question regarding filling of Table 3A and 3B of Model bioequivalence data summary tables-FDA.
Table 3A Statistical Summary of the Comparative Bioavailability Data for
Unscaled Average BE Studies.
Table 3B Statistical Summary of the Comparative Bioavailability Data for
Reference-Scaled Average BE Studies.

As per the form if Reference Scaled Average Bioequivalence Approach Used then complete Tables 3A and 3B

In one of our study we used Reference scaled approach for all three parameters (Swr >0.294 for Cmax, AUCt and AUCinf). Then here should we also need to analyse these parameters using unscaled approach?

—
Kumar Naidu

Complete thread:

Model bioequivalence data summary tables-FDAkumarnaidu 2014-08-20 07:04
- FDA: 90% CI for RSABE Helmut 2014-08-20 10:44
  - FDA: 90% CI for RSABE kumarnaidu 2014-08-20 13:30
    - FDA: 90% CI for RSABE Helmut 2014-08-20 14:10
      - Not cast in stone jag009 2014-08-22 16:40
        
        Not cast in stone nobody 2014-08-22 17:17
        
        Not cast in stone jag009 2014-08-23 06:21