cutoff time point based on PK? [NCA / SHAM]
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As per Methylphenidate FDA draft guidance cut-off time point should be Average of Tmax + 2*SD (Average and SD should be calculated from IR portion).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]
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As per Methylphenidate FDA draft guidance cut-off time point should be Average of Tmax + 2*SD (Average and SD should be calculated from IR portion).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]
Complete thread:
- calculation of cutoff time point in case of multiphasic modified release Biostats 2017-11-25 09:22
- cutoff time point based on PK? Helmut 2017-11-25 13:46
- cutoff time point based on PK?Biostats 2017-11-26 07:36
- cutoff time point based on PK? Helmut 2017-11-25 13:46