ICH S7A Safety pharmacology studies for human pharmaceuticals
Table of contents
This document provides a definition, general principles and recommendations for safety pharmacology studies. It applies to new chemical entities and biotechnology-derived products for human use. It can also be applied to marketed pharmaceuticals when appropriate (e.g. when adverse clinical events, a new patient population, or a new route of administration raises concerns not previously addressed).
Keywords: Safety pharmacology, central nervous system (CNS), cardiovascular system, respiratory system, study design, good laboratory practice (GLP)