Bioequivalence and Bioavailability Forum

EMA vs. FDA [BE/BA News]

posted by d_labes  – Berlin, Germany, 2012-03-07 11:26 (5220 d 09:41 ago) – Posting: # 8224
Views: 28,161

Dear Helmut,

❝ These recommendations are inline with recent product-specific guidances of the FDA (methylphenidate ER capsules: fasting 3 h, fed 4 h, zolpidem ER tablet: fasting 1.5 h, fed no cut-off).

with the exception that the FDA recommends (T = cut-off time)

Cmax,                     AUC(0-T), AUC(T-tlast) and AUC(0-inf)

whereas the EMA demands

Cmax(0-T), Cmax(T-tlast), AUC(0-T), AUC(T-tlast)

if I interpret the Q&A and the product specific guidances right.
As always "International harmonisation" . But 50% accordance is better then nothing.

Can we expect an additional burden by the two Cmax values?

What to do in cases where there are no distinct Cmax in both phases like the concentration-time curves of Methylphenidate ER products shown on slide 43 (bottom left) of the presentation you have linked?

BTW: I can't see any return of clinical reasoning in the EMA Q&A.

❝ "The identification of this cut-off time point should aim to describe the plasma concentrations in the first phase ... ".

Complete thread:

• EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 
  • 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. FDAd_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