Drug Products for Clinical Trials: An International Guide to Formulation-Production-Quality Control

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Donald Monkhouse, Christopher Rhodes
Taylor & Francis, Oct 24, 1997 - Medical - 406 pages
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This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies.

The only wide-ranging, up-to-date book of its kind available on the subject!

Describing both the science and management of product development, Drug Products for Clinical Trials
  • furnishes effective approaches for preclinical drug discovery
  • addresses the function of the clinical trials materials manager
  • covers the design of clinical protocols in developing a new chemical entity (NCE)
  • explains the importance of bioequivalence between clinical trials materials and final products
  • demonstrates rapid, reliable processes for clinical evaluation
  • discusses the interaction between clinical research, manufacturing, and packaging
  • reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world
  • and much more!
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