Overview of Safety Pharmacology
Safety pharmacology assesses the potential risks of novel pharmaceuticals for human use. ICH S7A guidelines recommend a core battery of studies on three vital systems: central nervous system (CNS), cardiovascular (CV) and respiratory. Primary CNS studies look for effects on general behavior, locomotion, neuromuscular coordination, the convulsive threshold, and vigilance. The primary CV test battery evaluates proarrhythmic risk using in vitro approaches (hERG channel and Purkinje fiber assays) and in vivo measurements in conscious animals via telemetry. Comprehensive cardiac risk assessment also includes full hemodynamic evaluation, most suitably conducted in the anesthetized large animal. Basic respiratory function can be approached via whole-body plethysmography in conscious animals where sensitivity to respiratory-depressant effects can be enhanced by exposure to increased CO
Keywords: safety pharmacology; risk assessment; ICH S7A guidelines; central nervous system; cardiovascular system; respiratory system
Table of Contents
- Unit Introduction
- Safety Pharmacology Versus Toxicology
- Comparison of Japanese and ICH Guidelines
- CNS Safety Pharmacology
- Cardiovascular Safety Pharmacology
- Respiratory Safety Pharmacology
- Timing of Safety Pharmacology Studies and Good Laboratory Practice
- Ethical and Animal Welfare Issues
- Statistical Evaluation
- Literature Cited
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The FDA's S7A safety guidelines for pharmacology studies of human pharmaceuticals.
The FDA's S7B safety guidelines for pharmacology studies of human pharmaceuticals.
Contains links to both the ICH S7A (Safety Pharmacology Studies for Human Pharmaceuticals) and S7B (The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals) safety guidelines.
The OECD Website contains comprehensive information about GLPs.