Current Practices Safety Pharmacological Study

摘要

Safety pharmacology is one of non-clinical evaluation aimed to assess the safety of medicinal products by examining the pharmacodynamic properties. Recently, ICH guideline for the safety pharmacological study is designed to obtain the information necessary to predict the potential adverse effects and assess the safety of the substance in humans. In this paper, we explain the circumstance of ICH guideline establishment and its summary, and describe our current prectices in evaluating of vital function, chiefly cardiovascular system, are considered to be the most important ones to assess in safety pharmacological studies.