Development and approval of combination products a regulatory perspective /

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Siegel, Evan B.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, c2008.
Temas:
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:Texto completo
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.

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