ABSTRACT
The International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) has issued a set of international
regulatory requirements and guidelines for safety pharmacology studies (ICHS7A; see
Appendix A) (1). The ICHS7A regulatory guidance document provides the following
definition of safety pharmacology:
Those studies that investigate the potential undesirable pharmacodynamic effects of
a substance on physiological functions in relation to exposure in the therapeutic
range and above.
