Preclinical Bioanalysis of Small Molecules

Preclinical Bioanalysis of Small Molecules Services

Pharmaron provides comprehensive small molecule-based bioanalytical service offerings at our laboratories in the US, the UK and China. Our team provides tailored solutions to support in vitro ADME, in vivo pharmacokinetics (PK), pharmacology, safety assessment (TK), and tissue distribution studies that meet global regulatory requirements (NMPA/FDA/EMA/ICH) and are governed by SOPs.

Our team provides analysis of parent molecules, metabolites and small molecule biomarkers to support in vitro ADME, toxicology (TK), pharmacokinetics (PK), PK/PD, pharmacology and tissue distribution studies, in support of regulatory submission.

  • Method development and optimization of transferred methods for the bioanalysis of small molecule-based samples for projects at the preclinical development stage
  • Fully GLP-compliant method validation per applicable guidelines by FDA, EMA, and NMPA agencies
  • Watson-LIMS® data management and sample tracking

Technology Platforms

  • Analytical platform: LC-MS/MS, HPLC/UV, HPLC/Fluorescence, ICP-MS techniques
  • Automated liquid handling platform: Bench-top automation stations, integrated workstations, advanced autosamplers

Analytes

  • Heterocyclic molecules, steroids, etc.
  • Lipids, PROTACs, protein-degraders, etc.
  • Peptides, ADC payloads, etc.
  • Nucleotides/nucleosides and oligonucleotides
  • Carbohydrates and oligosaccharides
  • Metabolites
  • Endogenous small molecule biomarkers
  • Sample matrix: plasma, blood, serum, urine, feces, tissue, CSF, etc.

Learn more about Pharmaron’s small molecule bioanalytical services