Clinical Sample Bioanalysis

Clinical Sample Bioanalysis

       Our pharmacokinetic lab has been offering customers the clinical sample bioanalysis service since 2015 and has provided the service for several domestic big pharm companies. We conduct all studies in compliance with the international GLP regulations and all data are in line with the requirements for audit and data tracking.

 

 

 

Service Highlights

  ■ Strictly compliant with regulations

  ■ Complete technology platform

  ■ Case-by-case service

  ■ In line with data tracking

Studies

  ■ Clinical pharmacokinetics

  ■ Bioequivalent

  ■ Immunogenicity

  ■ PK-PD study 

RegulatoryCompliance

  ■ Compliant with CFDA, FDA and OECD GLPs

  ■ CFDA guide to clinical trial samples bioanalysis

Bioanalysis

  ■ Method development and validation (LC-MS/MS, ELISA, ECL, PCR)

  ■ Sample bioanalysis

  ■ PK profiling and report writing

  ■ Data statistical analysis 

Immunogenicity

  ■ Method development and validation (ECL, ELISA, SPR)

  ■ Sample bioanalysis (screening, confirmation, titration,  neutralization, subtypes)

  ■ Data analysis and report writing

Determination of Biomarker

               ■ Method development and “Fit of Purpose” validation (LC-MS/MS, ELISA, ECL)

               ■ Sample bioanalysis

               ■ PK-PD-related study and modeling

        ■ Report writing