Bioequivalence and Bioavailability Forum • FDA more straight?

FDA more straight? [BE/BA News]

posted by d_labes – Berlin, Germany, 2012-03-08 09:29 (5212 d 21:40 ago) – Posting: # 8232
Views: 28,049

Dear Helmut!

From all what you have explained to me I have the impression that two so-called 'Cmax' values are not so very sound. I have the impression that the authors of the Q&A have had some ideal time courses with distinct bi-phases in their mind.

The FDA approach seems here more straight I think, taking the partial AUC as measure of 'early exposure' (as they have suggested already since times) and the one Cmax as measure of 'peak exposure'.

It suffers at least not from the inconsistencies in defining some 'C_max,I' or 'C_max,II' where no maximum is seen.

I think the discriminatory value of the partial AUC is well enough seen from the examples in the presentation.
Thus the additional metrics only raise the burden.

—
Regards,

Detlew

Complete thread:

EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 [BE/BA News]
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
  - EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
    - EMA: Q&A on biphasic MR products ElMaestro 2012-03-07 19:20
- EMA vs. FDA d_labes 2012-03-07 10:26
  - MPH examples Helmut 2012-03-07 14:22
    - MPH examples d_labes 2012-03-07 16:18
      - MPH examples Helmut 2012-03-08 01:07
        
        FDA more straight?d_labes 2012-03-08 08:29
        
        and what about power? ElMaestro 2012-03-08 11:37
        
        and what about power? d_labes 2012-03-08 13:26
        and what about power? Helmut 2012-03-08 13:36
        
        FDA more straight? Helmut 2012-03-08 12:51
        
        FDA more straight? luvblooms 2012-03-09 06:55
        
        Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
        
        Multiphasic MR ≠ DR jag009 2012-03-28 15:29
        
        Metadate CD (30/70) Helmut 2012-03-28 15:45