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.
Study items
- 1Drug concentration
Drug concentration will be measured by using analytical instruments (LC-MS/MS and HPLC) or immunological techniques (ELISA, RIA, EIA and more). - 2Biomarkers
Biomarker concentrations are determined to help predicting drug efficacy or side effect will be measured. If requested, customized measurement system will be developed. - 3Neutralizing 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. - 4Gene polymorphism analysis
Gene polymorphism analysis will be performed using real-time PCR.
Items
Analytical Method Development and Confirmation
We develop analytical methods using LC-MS/MS and HPLC or immunological methods using ELISA, RIA and EIA. We also offer confirmation of the analytical method when/if one was provided by the sponsor.
Validation of Analytical Methods
We conduct validation of provided or developed analytical methods in order to be compliant with various guidelines.
Sample Analysis
Sample analysis will be conducted using validated methods. We offer LC-MS/MS sample analysis in accordance with data integrity principles.
Analytical Method
Following methods are used.
- 1Instrumental Analysis
- 2Immunological Methods
ELISA, RIA, EIA and more