A equipe Biotec lhe deseja um
Feliz Natal e Próspero 2010
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics - 2/ED.
Editora: Informa Healthcare - 2008
Área: Ciências Farmacêuticas
N. Páginas: 464 págs
Prazo de entrega:
Livros nacionais: 30 dias úteis.
Livros importados: 60 dias úteis.
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, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
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