cutoff time point based on PK? [NCA / SHAM]

posted by Biostats – India, 2017-11-26 08:36 (1951 d 21:02 ago) – Posting: # 18006
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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As per Methylphenidate FDA draft guidance cut-off time point should be Average of Tmax + 2*SD (Average and SD should be calculated from IR portion).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?

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]

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