Clinical Study

We determine drug concentration, biomarker concentration and neutralizing antibody titer against biopharmaceuticals in biological samples that have been generated by a clinical study or a bioequivalence study, in compliance with the GLP standards.

Drug concentrations are determined using instrumental analysis (LC/MS/MS, HPLC) and immunological method (RIA, ELISA, CLEIA, FEIA, etc.).

Biomarker concentrations are determined to help predicting drug effects and adverse drug reactions. In the case of a special biomarker other than the existing biomarkers, we will develop a measurement system for it as well.

• Safety study

We detect neutralizing antibodies which have been induced by the administration of macromolecular preparations or biopharmaceuticals. Concerning false positives, we can offer a measurement system that allows an accurate evaluation by means of an absorption test with a drug (antigen) or dilution test.

We perform genetic polymorphism analysis using direct sequencing and TaqMan^® RT-PCR.

• Genetic polymorphism analysis

We will develop analytical methods using instruments such as LC/MS/MS and HPLC, and analytical methods using immunological methods such as RIA, EIA and CLEIA, as well as genetic polymorphism analytical methods.
If an established measurement system is provided by a customer, we will conduct a confirmation study of the measurement method.

We will perform validations of the developed or confirmed measurement system in compliance with various guidelines.

We measure samples using the validated measurement system in compliance with various guidelines.

The measurements are performed using the following methods.

1) Instrumental analysis (LC/MS/MS, HPLC)

2) Immunological analysis (RIA, ELISA, CLEIA, FIA, etc.)