EMA: Q&A Update; Expected studies for Quetiapine PR Tablets [BE/BA News]

posted by viveksraut – India, 2018-08-06 14:42 (786 d 17:58 ago) – Posting: # 19153
Views: 4,711

Dear all,

This is with reference to the point no. 14 (Quetiapine Lambda) of “Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP), EMA/618604/2008 Rev. 13” document published by EMA on 19 November 2015 )” to address specific questions in relation to pharmacokinetic evaluations and particularly the requirements and assessment of bioequivalence studies.

From the PKWP response to the point no. 14 question I understand the following;
So if applicant is developing generic version of Quetiapine prolonged release tablets and intended strengths are 25mg, 100mg, 200mg and 300 mg. Then in view of the PKWP response on this product and taking into account the guidance on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), 20 Nov 2014, what are the studies expected by EMA for this product ? Your opinion please on this.

Regards : Vivek

Complete thread:

Activity
 Admin contact
21,090 posts in 4,398 threads, 1,469 registered users;
online 20 (0 registered, 20 guests [including 6 identified bots]).
Forum time: Thursday 08:41 CEST (Europe/Vienna)

In these days, a man who says a thing cannot be done
is quite apt to be interrupted by some idiot doing it.    Elbert Green Hubbard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5