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Science/Engineering Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

Posted on 2010-03-16




Name:Science/Engineering Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control
ASIN/ISBN:082479852X
Language:English
File size:1.5 Mb
ISBN: 082479852X
Publish Date: January 15, 1998
File Type: PDF (OCR)
Pages: 387 pages
File Size: 4337 KB
Other Info: Informa HealthCare
   Science/Engineering Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control



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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control (Drugs and the Pharmaceutical Sciences): Donald Monkhouse, Christopher Rhodes

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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