Unit

UNIT 10.1 Overview of Safety Pharmacology

  1. Sonia Goineau,
  2. Martine Lemaire,
  3. Guillaume Froget

Published Online: 2 DEC 2013

DOI: 10.1002/0471141755.ph1001s63

Current Protocols in Pharmacology

Current Protocols in Pharmacology

How to Cite

Goineau, S., Lemaire, M. and Froget, G. 2013. Overview of Safety Pharmacology. Current Protocols in Pharmacology. 63:10.1.1–10.1.8.

Author Information

  1. Porsolt S.A.S, Le Genest-Saint-Isle, France

Publication History

  1. Published Online: 2 DEC 2013

Abstract

Safety pharmacology entails the assessment of the potential risks of novel pharmaceuticals for human use. As detailed in the ICH S7A guidelines, safety pharmacology for drug discovery involves a core battery of studies on three vital systems: central nervous (CNS), cardiovascular (CV), and respiratory. Primary CNS studies are aimed at defining compound effects on general behavior, locomotion, neuromuscular coordination, seizure threshold, and vigilance. The primary CV test battery includes an evaluation of proarrhythmic risk using in vitro tests (hERG channel and Purkinje fiber assays) and in vivo measurements in conscious animals via telemetry. Comprehensive cardiac risk assessment also includes full hemodynamic evaluation in a large, anesthetized animal. Basic respiratory function can be examined in conscious animals using whole-body plethysmography. This allows for an assessment of whether the sensitivity to respiratory-depressant effects can be enhanced by exposure to increased CO2. Other safety pharmacology topics detailed in this unit are the timing of such studies, ethical and animal welfare issues, and statistical evaluation. Curr. Protoc. Pharmacol. 63:10.1.1-10.1.8. © 2013 by John Wiley & Sons, Inc.

Keywords:

  • safety pharmacology;
  • risk assessment;
  • ICH S7A guidelines;
  • central nervous system;
  • cardiovascular system;
  • respiratory system