１．医薬品の市販後安全性に関する研究

抄録

The National Institute of Health Sciences (NIHS) is the oldest national institute in Japan. The NIHS is engaged in so-called regulatory science, which harmonizes science/technology and daily human life. The Division of Medicinal Safety Sciences (MSS) was founded in 2002, and is one of the newest branches of the NIHS. The aim of the MSS is to conduct basic research concerning post-marketing drug safety. Its main research topics are as follows: research on severe cutaneous adverse events (Stevens-Johnson syndrome/toxic epidermal necrolysis) and related gene markers, analysis of the relationship between response to selective serotonin reuptake inhibitors and gene markers, research on individual factors associated with adverse effects of anticancer drugs, investigation of individual factors that affect P-glycoprotein expression level, drug utilizing study, survey of attitudes toward the necessary information of drug labeling, research on conflict of interest in collaboration study with drug companies, and comparative pharmacokinetic study between the East Asians and Caucasians. As listed above, the MSS covers broad research areas, but its research purpose of post-marketing drug safety study is well defined. The MSS is a unprecedent case of regulatory science research. The unique standpoint of the MSS will be strengthened by interdisciplinary collaboration.