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

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