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In recent years it has become clear that early information about pharmacodynamics leads to more efficient trial designs and improved clinical guidelines for the use of all drugs. Spanning many of the major drug classes, this book offers the essential facts and concepts and includes an authoritative section on general methodology and regulatory issues. The molecular biology and pharmacology of major receptor types are considered, as is the detailed pharmacodynamics of a wide range of therapeutic drug classes. The book will be of interest to researchers, clinical pharmacologists, physicians and regulators working in academia as well as the pharmaceutical industry worldwide.
Clinical trials are the most definitive tool for evaluation of the applica bility of clinical investigations. The main objective of clinical investiga tions is to assess the potential value of a therapeutic entity in the treat ment or prophylaxis of a disease or a condition. It is also deemed necessary at this stage to obtain information regarding the undesirable side effects, associated risks, and their interrelationship with clinical assessments. Most of these clinical investigations conform, in some form or fashion, to the guidelines adopted by the Food and Drug Administration (FDA) for a given class of compounds. Clinical investigations in the past have not included specific studies in special or subpopulations, e.g., the elderly. Because of an ever-increasing elderly population, newer policies for clinical investigations are now being debated with the recognition of enhanced drug sensitivity in this special population. This key research activity can lead not only to improved health care in the elderly but also to control of its costs."
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