ABSTRACT
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.
TABLE OF CONTENTS
part I|96 pages
Preliminaries to Testing of Drugs in Man
part II|39 pages
Organisation and Decision Making
part III|55 pages
Ethical and Legal Considerations
part IV|58 pages
Measuring Drug Activity in Man
part V|97 pages
Assessment of Drug Effects on the Cardiovascular System
part VI|27 pages
Assessment of Drug Effects on the Respiratory System
part VII|77 pages
Assessment of Drug Effects on the Central Nervous System
part VIII|37 pages
Assessment of Drug Effects on the Gastrointestinal System
part IX|25 pages
Assessment of Drug Effects on the Kidney
part X|31 pages
Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology
part XI|47 pages
Assessment of Drug Activity in the Skin
part XII|25 pages
Assessment of Drugs Used for the Treatment of Metabolic Disorders
part XIII|30 pages
Assessment of the Effects of Chemotherapeutic Agents
part XIV|47 pages
Assessment of Drugs Affecting the Inflammatory Process and Pain