Drug Products for Clinical Trials: An International Guide to Formulation-Production-Quality Control (Drugs and the Pharmaceutical Sciences)

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Press: CRC Press; 1st edition (October 24, 1997)
Publication Date:1997-10
ISBN:9780824798529
Pages:406
Language:English
Edition:1st Edition

Content

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 Trialsfurnishes 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!

Tags

Medical Books,Pharmacology,Chemistry,Textbooks,Medicine & Health Sciences,Allied Health Services,Pharmacy



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  •     Good communication but very expensive postage.

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