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Drug Products for Clinical Trials: An International Guide to Formulation-Production-Quality Control
Informa Healthcare, Jan 1997, Pages: 406
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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