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Nonclinical development of novel biologics, biosimilars, vaccines and specialty biologics /

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Bibliographic Details
Corporate Author: ProQuest (Firm)
Other Authors: Plitnick, Lisa M. (Editor), Herzyk, Danuta J. (Editor)
Format: eBook
Language:English
Published: Amsterdam : Elsevier/Academic Press, 2013.
Subjects:
Biologicals.
Biological products.
Biopharmaceutics.
Biological Products.
Ebooks.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Overview of biopharmaceuticals and comparison with small-molecule drug development
  • Regulatory guidelines and their application in the nonclinical evaluation of biological medicines
  • Early de-risking strategy for novel biotherapeutics
  • Novel biopharmaceuticals : pharmacokinetics, pharmacodynamics, and bioanalytics
  • Overview of biosimilar therapeutics
  • Regulatory standards for the approval of biosimilar products : a global review
  • Early characterization of biosimilar therapeutics
  • Introduction to vaccines and adjuvants
  • Global regulatory guidelines for vaccines
  • Special considerations for the nonclinical safety assessment of vaccines
  • Turning the corner with viral-based gene therapy : development of the rogue biopharmaceutical
  • Blood products
  • Biological therapies for cancer
  • Nonclinical development of multi-targeting biopharmaceuticals
  • Considerations in the development of pluripotent stem cell-based therapies.