Development and approval of combination products a regulatory perspective /

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Detalles Bibliográficos
Autor Corporativo:	ebrary, Inc
Outros autores:	Siegel, Evan B.
Formato:	Electrónico eBook
Idioma:	inglés
Publicado:	Hoboken, N.J. : Wiley, c2008.
Subjects:	United States. > Food and Drug Administration. Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States. Electronic books.
Acceso en liña:	An electronic book accessible through the World Wide Web; click to view
Tags:	Engadir etiqueta Sen Etiquetas, Sexa o primeiro en etiquetar este rexistro!

Table of Contents:

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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