ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline

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)

Current effective version

ICH: S 7 A: Safety pharmacology studies for human pharmaceuticals - Step 5

Adopted Reference Number: CPMP/ICH/539/00 Legal effective date: 01/06/2001