Drug Products for Clinical Trials

An International Guide to Formulation-Production-Quality Control

Edited by Donald Monkhouse, Christopher Rhodes

© 1997 – CRC Press

406 pages

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About the Book

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!
  • Reviews


    This practical guide…offer[s] authoritative evaluations of the scientific & legal issues involved in the successful completion of clin trials for marketing approval by regulatory agencies.

    "-Unlisted Drugs

    "…very comprehensive on the subject and does give a lot of how-to information.

    …very well written and very much geared towards the US market and Food and Drug Administration requirements….

    …covers the process of clinical development and the involvement of the clinical trials materials manager at all stages.

    There is an excellent chapter on contract manufacturing.

    "-European Journal of Parenteral Sciences

    "…describes both the science and the management of product development and furnishes effective approaches for preclinical drug discovery."-BOOKNews on the Internet

    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

    About the Series

    Drugs and the Pharmaceutical Sciences

    Learn more…

    Subject Categories

    BISAC Subject Codes/Headings:
    MEDICAL / Pharmacology