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

posted by viveksraut – India, 2018-08-06 16:42 (2146 d 08:22 ago) – Posting: # 19153
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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

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[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
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Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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