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

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!