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
PRELIMINARIES TO TESTING OF DRUGS IN MAN. The Pharmaceutical Background. The Pharmacological Background. The Metabolic Background. The Toxicological Background. Animal Tests as Predictors of Human Response. International Regulatory Requirements. Regulatory Requirements in Japan. ORGANISATION AND DECISION MAKING. The Organisation of New Drug Evaluation in the Pharmaceutical Industry. The Role of Contract Research Units. Decision Points in Human Drug Development. Good Clinical Research Practice and Quality Assurance. ETHICAL AND LEGAL CONSIDERATIONS. Ethical Aspects of Research in Healthy Volunteers. Ethical Aspects of Research in Patients. Legal Liabilities in Clinical Trials. MEASURING DRUG ACTIVITY IN MAN. The Assessment of Tolerance and Side-Effects in Non-Patient Volunteers. Design of First-Administration Studies in Healthy Man. The Detection and Assessment of Adverse Reactions in Early Phase Patient Trials. The Assessment of Pharmacodynamic Effects. The Assessment of Pharmacokinetics. Radiolabelled Metabolism Studies in Man. ASSESSMENT OF DRUG EFFECTS ON THE CARDIOVASCULAR SYSTEM. Non-Invasive Measurement of Cardiovascular Response. Anti-Anginal Drugs. Anti-Arrhythmic Agents. Phase I Trials on Anti-Hypertensive Drugs. Drugs for Heart Failure. Antithrombotic and Thrombolytic Drugs. Monitoring of Antithrombotic Activity by Platelet Labelling. ASSESSMENT OF DRUG EFFECTS ON THE RESPIRATORY SYSTEM. Assessment of Respiratory Responses. Anti-Asthmatic Drugs. ASSESSMENT OF DRUG EFFECTS ON THE CENTRAL NERVOUS SYSTEM. Measurement of CNS Effects. Drugs in Epilepsy. Anxiolytics. Hypnotics. Antidepressants. Antipsychotic Agents. ASSESSMENT OF DRUG EFFECTS IN THE GASTRO-INTESTINAL SYSTEM. Measurement of Gastro-Intestinal Effects. Anti-Ulcer Drugs. ASSESSMENT OF DRUG EFFECTS ON THE KIDNEY. Diuretics. Measurement of Renal Side-Effects. ASSESSMENT OF THE EFFECTS OF DRUGS USED IN OBSTETRICS AND GYNAECOLOGY. Abortifacient Drugs. Oxytocic Drugs. ASSESSMENT OF DRUG ACTIVITY IN THE SKIN. Measurement of Skin Response to Drugs. Drugs for Eczema. Drugs Affecting Hair Growth. ASSESSMENT OF DRUGS USED FOR THE TREATMENT OF METABOLIC DISORDERS. Hypolipidaemic Drugs. Antidiabetic Drugs. ASSESSMENT OF THE EFFECTS OF CHEMOTHERAPEUTIC AGENTS. Antibacterial Drugs. Antiviral Drugs. Anticancer Drugs. ASSESSMENT OF DRUGS AFFECTING THE INFLAMMATORY PROCESS AND PAIN. Drugs Affecting the Immune Response. Anti-Inflammatory Drugs. Analgesics. Index. 748 pp., 6 x 9, 1990, ISBN 0-8493-7708-0.