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