Analysis of Clinical Samples
Concentration of drug and biomarkers and titer of neutralizing antibody in biological samples obtained from clinical study or bioequivalence study will be measured in accordance with GLP compliance.
- 1.Drug concentration
Drug concentration will be measured by using analytical instruments (LC/MS/MS and HPLC) or immunological techniques (RIA, ELISA, CLEIA, FEIA and so on).
Biomarker concentrations are determined to help predicting drug efficacy or side effect will be measured. If requested, customized measurement system will be developed.
- 3.Neutralizing antibody
Concentration of neutralizing antibody caused by administration of macromolecular drug such as biopharmaceutical will be measured by the immunological techniques. Measurement system can be proposed to avoid false positive by conducting absorption study with drug (antigen) and dilution study.
- 4.Gene polymorphism analysis
Gene polymorphism analysis will be performed using direct sequencing and Tac Man® RT-PCR.