Safety Study

We conduct the following studies with samples obtained from a safety study.

We develop assay/analysis systems to measure samples obtained from a safety study, validate them, and then perform measurements of the samples in compliance with the GLP^* standard.

^*We conduct any measurement in compliance with GLP regulations (MHW Rule No. 21) "Good Laboratory Practice (standards for non-clinical safety study of pharmaceuticals)."

January 2007: PMDA (Organaization for Pharmaceutical Safety and Research) GLP review for toxicokinetics study: rating "A"

We use the following analysis systems for assay/analysis systems.

• Instrumental analysis (LC/MS/MS, HPLC).
• Immunological measurement (RIA, ELISA, EIA).
• It is possible to perform measurements simultaneously with the above systems.

We conduct a wide variety of studies ranging from comprehensive gene analysis through gene expression analysis focusing on toxicity, to the quantitative evaluation of target genes of toxicity markers to meet the customers' needs.

We establish analysis systems for an assigned biomarker using the immunological and gene analysis methods, as well as perform measurements of samples in compliance with the GLP standards.

• Immunological methods include RIA, EIA and RRA.
• Gene analysis methods cover gene expression analysis (GeneChip^® Expression Array, TaqManR RT-PCR, etc.) and genetic polymorphism analysis (direct sequence, TaqMan^® RT-PCR).
• We will determine the concentration of biological samples (from animals and humans) generated at various settings including the drug discovery stage, non-clinical study, clinical study and post-marketing survey.
• We are ready to determine drug concentration determination using a combination of instrumental analysis (LC/MS/MS, HPLC) and immunological methods (RIA, ELISA).