Full Description
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.
Contents
I Research Determinants in Aging.- 1 Epidemiology and Demography of Aging: Some Lessons in Shortsightedness.- 2 Age: A Complex Variable.- 3 Physiological Changes with Aging: Relevance to Drug Study Design.- 4 Immunity and Aging.- 5 Cardiovascular Changes with Aging.- 6 The Effects of Age on Hepatic Drug Metabolism.- 7 Hematological Effects of Aging: Considerations for Clinical Trials.- 8 The Aging Brain.- II Pharmacokinetics and Pharmacodynamics in the Elderly.- 9 The Tricyclic Antidepressants.- 10 Methodological Concerns for Clinical Trials in Geriatrics: Benzodiazepines.- 11 Effect of Age on the Clinical Pharmacokinetics of Antiarrhythmic Drugs.- 12 Beta Blockers in the Elderly.- 13 Antiepileptic Drugs in the Elderly.- 14 Pharmacokinetics and Bioavailability of Corticosteroids in the Treatment of Neurological Diseases of the Elderly.- 15 Pharmacological Treatment of Parkinson's Disease.- 16 Cognitive Enhancers in Alzheimer's Disease.- III General Perspectives.- 17 Dosage Form Considerations in Clinical Trials Involving Elderly Patients.- 18 Clinical Trial Design—Industry Perspective.- 19 Methodological Issues: A Regulatory Perspective.- 20 Statistical Analysis of Drug Disposition Data.- 21 Analytical Methods.- 22 Nursing Perspectives on Clinical Trials in Geriatrics.
