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Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

Drawing on the experience of project managers from international pharmaceutical companies, this work reviews up-to-date strategic, operational and organizational procedures for drug development in today's competitive industry. It includes details of how target product profiles are established and used to direct drug development; and project definition and risk management, including analytical techniques and asset valuation at the project and portfolio levels.