Корично изображение Електронна книга

Development and approval of combination products : a regulatory perspective /

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.

Други автори: Siegel, Evan B.
Формат: Електронна книга
Език: English
Публикувано: Hoboken, N.J. : Wiley, ℗♭2008.
Предмети:
United States. > Food and Drug Administration.
Drug approval > United States.
Biological products > United States.
Medical instruments and apparatus > United States.
Drug Approval > legislation & jurisprudence.
Drug Combinations.
Device Approval > legislation & jurisprudence.
HEALTH & FITNESS > Safety.
Biological products.
Drug approval.
Medical instruments and apparatus.
United States.
United States > .
Electronic books.
Онлайн достъп: http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=231165
Подобни документи: Print version:: Development and approval of combination products.
Съдържание:
  • 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.

Подобни библ. документи