Bioanalysis
Pharmaron provides global bioanalytical support for clinical and non-clinical programs. Our experienced teams use state-of-the-art instrumentation to deliver high quality bioanalytical data in support of drug pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and biomarkers for drug discovery through clinical development.
Bioanalysis for IND Enabling Studies
- Method optimization to support GLP bioanalysis
- Full method validation per FDA/EMA/NMPA guidance
- GLP sample analysis to support toxicology (TK) and pharmacokinetics (PK)
- Large molecule PK/PD, immunogenicity (ADA), biomarkers and neutralizing antibody (NAb) assays
- Critical reagent qualification and management
Bioanalysis for Clinical Development: Phase l-lll Clinical Trials
- Standardized global bioanalytical technology platforms in China, UK and US
- Full method validation per FDA/EMA/NMPA guidance
- GCP sample analysis by LC-MS/MS and ligand binding assays to support clinical PK studies
- PD, ADA, NAb, biomarkers and cell-based assay development, validation and analysis
- Critical reagent selection, qualification and stability monitoring
- Flow cytometry and immunophenotyping panels
- Sample management services
Clinical Metabolism: LSC, AMS, LC-AMS and LC-MS/MS Analysis
- Ultra-sensitive quantitation of total 14C by AMS and specific 14C analytes by LC-AMS
- Method development/transfer of HPLC and UPLC for MS & AMS detection
- Full method validation of LC-MS/MS and LC-AMS bioanalytical assays for parent/metabolites
- Metabolite profiling by LC-RAD, LC-TopCount® and/or LC-AMS
- Metabolite identification (structure elucidation) by HRMS, NMR