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An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014: A Focus on Benefit-Risk and

Dominik Sawicki-Wrzask1, Mikael Thomsen2, Ole J Bjerrum1

  • 11 Institute for Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Therapeutic Innovation & Regulatory Science
|September 18, 2018
PubMed
Abstract

Keywords:
combination therapyinnovative developmentnew therapeutic entityregulatory guidelinesreimbursementunmet medical need

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