Drug products for clinical trials : an international guide to formulation, production, quality control

著者

    • Monkhouse, Donald C.
    • Rhodes, Christopher T.

書誌事項

Drug products for clinical trials : an international guide to formulation, production, quality control

edited by Donald C. Monkhouse, C.T. Rhodes

（Drugs and the pharmaceutical sciences, v. 87）

M. Dekker, c1998

大学図書館所蔵 件 / 全2件

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

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!

目次

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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