Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-13 16:00 CET (UTC+1h)
 

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

posted by Biostats - India, 2017-11-25 09:22  - Posting: # 18004
Views: 418

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]

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,556 Posts in 3,758 Threads, 1,089 registered users;
31 users online (0 registered, 31 guests).

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed