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
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.
"…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
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