Drug products for clinical trials : an international guide to formulation, production, quality control
Author(s)
Bibliographic Information
Drug products for clinical trials : an international guide to formulation, production, quality control
（Drugs and the pharmaceutical sciences, v. 87）
M. Dekker, c1998
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Note
Includes bibliographical references and index
Description and Table of Contents
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!
Table of Contents
The Importance of the Role of the Clinical Trials Materials Manager, Donald C. Monkhouse and C. T. Rhodes
Drug Discovery Considerations, Andrew J. Gorman and David Bergstrom
Clinical Development of a New Chemical Entity, Graham J. Frank
Formulations Used in Clinical Trials and Their Bioequivalency to Marketed Product, C. T. Rhodes
Drug Substance Development Issues in the Control and Production of Clinical Supplies, Vasken Paragamian
Formulation Design Considerations, John M. Baldoni and Choon K. Oh
Planning for Clinical Trial Supplies: Interaction Between Clinical Research
Clinical Manufacturing, and Clinical Packaging, Cary Blume
Clinical Supply Manufacture, Gary W. Goodson and William C. Stagner
Clinical Supply Packaging, Dorothy M. Dolfini and Frank J. Tiano
Quality Control, Christopher J. Potter
Stability of Drugs and Drug Products in Clinical Packaging, Jens T. Carstensen
Containment Facilities for Production of Clinical Supplies, John E. Vogan and Jean Corriveau
Contract Manufacturing and Packaging of Clinical Trial Supplies, Maureen E. Spataro and Michael G. Dragoon
Overseas Trials, Peter J. Baines, Susan A. Charman, Gillian M. Clarke, Robin S. Roman, and Susan M. Walters
Blinding Clinical Trial Supplies, Thomas L. Jeatran and James Clark
Application of Computers in the Production and Control of Clinical Trial Supplies, Jeffrey D. Kosterich
Total Quality Management of Clinical Trial Supplies, Nicholas P. Barker
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