Bioequivalence and Bioavailability Forum

Dear Sir,

Thanks for your prompt response

As per Methylphenidate FDA draft guidance cut-off time point should be Average of Tmax + 2*SD (Average and SD should be calculated from IR portion).

Can we apply this method for EMA submission?

Can we apply reference-scaling for all seven pk parameters or only for pk parameters from first phase i.e. Cmax(1) & AUC(1) as expected large intra-subject variability in first phase?

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]