New EU guidance for the evaluation of medicinal products with modified drug release will be finished by the middle of 2014
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 2
Abstract
The guideline ‘Note for guidance on modified release oral and transdermal dosage forms: Section II (Pharmacokinetic and clinical evaluation)’ [1] was issued over 10 years ago, and the need for revision was recognized in 2010. An international group of experts, led by Austrian members of the Pharmacokinetics Working Party, is responsible for its implementation. They have joined forces with the Quality Working Party, which revises guidelines on the quality of such products, and various other expert groups of the European Medicines Agency (EMA). A draft version was recently produced and approval obtained from EMA’s Committee for Medicinal Products for Human Use; it was then posted on the EMA website for feedback [2].
Authors and Affiliations
Christoph Baumgärtel, Jan Neuhauser
Keywords
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- EP ID EP354465
- DOI 10.5639/gabij.2014.0302.024
- Views 77
- Downloads 0
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