Animal and Clinical Pharmacologic Techniques in Drug Evaluation

Abstract

Much so-called "clinical pharmacology" is being practiced by physicians inadequately prepared for the task. The general practitioner agreeing to undertake "some drug trials on his patients" is usually in a rather poor position to assess the claims presented by pharmaceutical firms. His concept of what constitutes an acceptable experimental design in drug evaluation in either animal or human is hazy at best. The present volume resulted from a training program in clinical pharmacology organized at Hahnemann Medical College and Hospital. Basic objectives and general principles of clinical pharmacology are defined. Among the general topics presented are variability in drug response; drug screening and the evaluation of new compounds in animals; kinetics of absorption, distribution, excretion, and metabolism of drugs; statistical problems in the planning and performance of clinical trials; and general principles in experimental design in drug evaluation in man. Legal considerations in testing new drugs in humans are also