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