The textbook of pharmaceutical medicine - Griffin, J. P. (John Parry); O'Grady, John, Professor (Oxford ; Malden, Mass. : Blackwell, 2006)
European regulation of medicinal devices / Christopher J.S. Hodges -- Technical requirements for registration of pharmaceuticals for human use : the ICH process / Dean W.G. Harron -- The regulation of drug products by the United States food and drug administration -- Peter Barton Hutt -- The US FDA in the drug development, evaluation and approval process / Richard N. Spivey, Judith K. Jones, William Wardell and William Vodra -- Past evolution and future prospects of the Pharma Industry and its regulation in the USA / William Wardell, William Vodra, Judith K. Jones and Richard N. Spivey -- Regulatory and clinical trial approval systems in Japan / Yuichi Kubo -- The regulation of therapeutic products in Australia / Janice Hirshorn and Deborah Monk -- Economics of healthcare / Carole Bradley and Jane R. Griffin -- Controls on NHS medicines prescribing and expenditure in the UK (an historical perspective) with some international comparisons / John P. Griffin and Jane R. Griffin
Keywords: Drug Approval; Clinical trials; Pharmacology