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Development and approval of combination products a regulatory perspective /

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Bibliografski detalji
Autor kompanije: ebrary, Inc
Daljnji autori: Siegel, Evan B.
Format: Elektronički e-knjiga
Jezik:engleski
Izdano: Hoboken, N.J. : Wiley, c2008.
Teme:
United States. > Food and Drug Administration.
Drug approval > United States.
Biological products > United States.
Medical instruments and apparatus > United States.
Electronic books.
Online pristup:An electronic book accessible through the World Wide Web; click to view
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Sadržaj:
  • 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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