Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

Author:

Duijnhoven Ruben G.,Straus Sabine M. J. M.,Raine June M.,de Boer Anthonius,Hoes Arno W.,De Bruin Marie L.

Publisher

Public Library of Science (PLoS)

Subject

General Medicine

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5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1994) ICH harmonised tripartite guideline: the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions—E1. Available: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E1/Step4/E1_Guideline.pdf. Accessed 8 February 2013.

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