New EU guidance for the evaluation of medicinal products with modified drug release will be finished by the middle of 2014

Author(s): Christoph Baumgärtel, MD, MSc, Jan Neuhauser, MD

Submitted: 2 March 2014; Revised: 7 March 2014; Accepted: 8 March 2014; Published online first: 21 March 2014 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 […]

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