Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, c GMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Formato PDF ● Páginas 464 ● ISBN 9781420073553 ● Editor David S. (Cubist Pharmaceuticals, Lexington, Massachusetts, USA) Mantus & Douglas J. Pisano ● Editora CRC Press ● Publicado 2008 ● Carregável 3 vezes ● Moeda EUR ● ID 4116462 ● Proteção contra cópia Adobe DRM
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