Development and approval of combination products : a regulatory perspective /

Mostrar otras versiones (1)

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufa.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Siegel, Evan B.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2008.
Temas:
United States. > Food and Drug Administration.
United States > Food and Drug Administration
United States. > Food and Drug Administration
Drug approval > United States.
Biological products > United States.
Medical instruments and apparatus > United States.
Médicaments > Autorisation de mise sur le marché > États-Unis.
Produits biologiques > États-Unis.
Médecine > Appareils et instruments > États-Unis.
HEALTH & FITNESS > Safety.
Biological products
Drug approval
Medical instruments and apparatus
United States
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.

Ejemplares similares