Safety Pharmacology
Abstract
Safety pharmacology studies defined as those studies that investigate the potential undesirable pharmacodynamics effects of a substance on physiological functions. It is the discipline that seeks to predict whether a drug (in the widest sense of the word), if administered to human (or animal) populations, is likely to be found unsafe, and its professional mandate is to prevent such an occurrence. The future of safety pharmacology will depend, in part, upon the scientific and technological advances and regulatory challenges that envelop pharmaceutical development. This review is aimed to provide a brief knowledge regarding safety pharmacology.
Keywords: Pre clinical safety, Safety Pharmacology, Safety Evaluation, pharmacodynamics,
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With advances in molecular biology and biotechnology, which allows for the identification of new clinical targets, newer pharmaceutical agents are, being identified that act at these novel molecular sites in an attempt to ameliorate the disease condition. Inherent in the novelty of new targets is the risk of unwanted effects that may or may not be detected with current techniques.
The scientific challenge facing safety pharmacology is to keep pace, to adapt, and to incorporate new technologies in the evaluation of new drugs in nonclinical models and identifying the effects that pose a risk to human volunteers and patients. Recent examples include safety pharmacology’s embracement of modern electrophysiological techniques to evaluate the effects of new drugs on the ionic components of the cardiac action potential, and telemetry techniques to permit the chronic monitoring of physiological functions in unstressed animals. Efforts continue to construct databases relating the similarities and differences between animal and human responses to pharmaceutical agents. As an example, nonclinical safety studies, including safety pharmacology studies, are typically conducted in normal, healthy, young adult or adult animals. However, these tests may not appropriately detect specific responses in humans at other ages (e.g., neonates, adolescents, and geriatrics) or those with underlying chronic diseases (e.g., heart failure, renal failure, and type II diabetes), conditions which may alter the pharmacodynamics response to a
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