Development and approval of combination products a regulatory perspective /

I tiakina i:
Ngā taipitopito rārangi puna kōrero
Kaituhi rangatōpū: ebrary, Inc
Ētahi atu kaituhi: Siegel, Evan B.
Hōputu: Tāhiko īPukapuka
Reo:Ingarihi
I whakaputaina: Hoboken, N.J. : Wiley, c2008.
Ngā marau:
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Rārangi ihirangi:
  • 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.