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Registercalculation of cutoff time point in case of multiphasic modified release [NCA / SHAM]
Dear all,
As per EMA guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms in section 6.8.1.1 single dose studies
“For multiphasic modified release products additional parameters to be determined include partialAUC, Cmax and tmax in all phases. The time point for truncating the partialAUC should be based on the PK profile for the e.g. IR and the MR parts respectively and should be justified and pre-specified in the study protocol.”
Is there any scientific method or formula to calculate the time point for truncating the partial AUC (cutoff time point)?
Edit: Category changed; see also this post #1. [Helmut]
As per EMA guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms in section 6.8.1.1 single dose studies
“For multiphasic modified release products additional parameters to be determined include partialAUC, Cmax and tmax in all phases. The time point for truncating the partialAUC should be based on the PK profile for the e.g. IR and the MR parts respectively and should be justified and pre-specified in the study protocol.”
Is there any scientific method or formula to calculate the time point for truncating the partial AUC (cutoff time point)?
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- calculation of cutoff time point in case of multiphasic modified releaseBiostats 2017-11-25 09:22 [NCA / SHAM]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
Ing. Helmut Schütz