Guideline on the Preparation of Investigational New Drug Products (Human and Animal)
Rockville, MD: The Center, March 1991, 13p. [available from: Division of Manufacturing and Product Quality, Office of Compliance, CDER, USFDA, 5600 Fishers Lane, Rockville, MD 20857]
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Commission Directive 2005/28/EC of 8 April 2005 Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of The Manufacturing or Importation of Such Products Unknown author (Commission of the European Communities, 1995-04-09)