Development and approval of combination products a regulatory perspective /

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Detalhes bibliográficos
Outros Autores:	Siegel, Evan B.
Formato:	Recurso Electrónico livro electrónico
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:	https://biblioteca.ues.edu.sv/acceso/elibro/?url=https%3A%2F%2Felibro.net%2Fereader%2Fbiblioues/177758 Ver en el OPAC
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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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