calculation of cutoff time point in case of multiphasic modified release [NCA / SHAM]

posted by Biostats – India, 2017-11-25 08:22 (1151 d 22:57 ago) – Posting: # 18004
Views: 2,660

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]

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