Development and approval of combination products a regulatory perspective /

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Dettagli Bibliografici
Ente Autore:	ebrary, Inc
Altri autori:	Siegel, Evan B.
Natura:	Elettronico eBook
Lingua:	inglese
Pubblicazione:	Hoboken, N.J. : Wiley, c2008.
Soggetti:	United States. > Food and Drug Administration. Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States. Electronic books.
Accesso online:	An electronic book accessible through the World Wide Web; click to view
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Sommario:

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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