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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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