Tabla de Contenidos: Development and approval of combination products

Detalles Bibliográficos
Otros autores:	Siegel, Evan B.
Formato:	Electrónico
Idioma:	English
Fecha de publicación:	Hoboken, N.J. : Wiley, c2008.
Materias:	United States. > Food and Drug Administration. Drug approval > United States. Biological products > United States. Medical instruments and apparatus > United States. Electronic books.
Acceso en línea:	https://recursos.uloyola.es/login?url=https://accedys.uloyola.es:8443/accedix0/sitios/ebook.php?id=177758

Tabla de Contenidos:

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.