ADME & Tox. Research Institute

We established an institute in Tokai-mura, Ibaraki Prefecture, Japan in May 1965 with the objective of contributing to the advance and development of academic research through our radioisotope business.
Its main business covers the custom synthesis of radiolabeled compounds and pharmacokinetic studies, offering new research in line with scientific advances.

Recently, the environment surrounding the development of drugs has greatly changed along with the progress in ICH organized by the three parties of Japan, the US and the EU. Therefore, there is an increasing demand for studies on the characteristics of individual drugs, and in conformity with the new guidelines, studies are being carried out on drug interactions, clinical pharmacokinetics, and microdose; the studies are also designed so as to provide data mutually acceptable in various countries. Genomic science covering genes and proteins has progressed remarkably, and therefore it is expected to produce applications to the development of appropriate candidate compounds for drugs even at the drug discovery stage.

The institute has established a Quality Assurance System for the implementation of GLP and pharmacokinetic studies so as to handle the research studies for drug applications. In addition, we constructed an evaluation system consisting of efficacy, toxicity, and pharmacokinetic screening evaluations to support a practical and efficient procedure for drug development.