Bioequivalence and Bioavailability Forum • FDA: 90% CI for RSABE

FDA: 90% CI for RSABE [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2014-08-20 12:44 (4327 d 23:44 ago) – Posting: # 13411
Views: 9,366

Hi Kumar,

❝ […] filling of Table 3A and 3B of Model bioequivalence data summary tables-FDA.

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

Yes, that’s funny. See this thread and especially what John does.

❝ 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?

I don’t think so. I would tick ☑ Yes in Table 3A and give in columns Ratio and 90% C.I.: NA. IMHO, it is sufficient to give the required information in Table 3B.

For the 90% CI in Table 3B use the intra-subject contrasts of the RSABE-code (Intermediate analysis – ilat). The statement cl alpha=0.1 gives you the 90% CI in log-scale. Back-transform it to raw scale.

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Complete thread:

Model bioequivalence data summary tables-FDA kumarnaidu 2014-08-20 07:04
- FDA: 90% CI for RSABEHelmut 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