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
Format PDF ● Seiten 464 ● ISBN 9781420073553 ● Herausgeber David S. (Cubist Pharmaceuticals, Lexington, Massachusetts, USA) Mantus & Douglas J. Pisano ● Verlag CRC Press ● Erscheinungsjahr 2008 ● herunterladbar 3 mal ● Währung EUR ● ID 4116462 ● Kopierschutz Adobe DRM
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