Development and approval of combination products a regulatory perspective /

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Detalhes bibliográficos
Autor Corporativo:	ebrary, Inc
Outros Autores:	Siegel, Evan B.
Formato:	Recurso Eletrônico livro eletrônico
Idioma:	inglês
Publicado em:	Hoboken, N.J. : Wiley, c2008.
Assuntos:	United States. > Food and Drug Administration. Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States. Electronic books.
Acesso em linha:	An electronic book accessible through the World Wide Web; click to view
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Sumário:

Overview of combination products development and regulatory review / Evan B. Siegel
Detailed regulatory approaches to development, review, and approval / James Barquest
Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings
Clinical pharmacology and clinical development of combination products / Chaline Brown
Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier.

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