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LC-MS/MS

ICON’s dedicated method development teams have extensive experience developing and validating robust bioanalytical LC-MS/MS methods in plasma, urine, other biofluids and tissue samples to support pre-clinical and Phase 1 through Phase 4 clinical trials.

We support traditional small molecule analysis by LC-MS/MS, but also peptide and oligonucleotide analysis and protein measurements, either using signature peptides after enzymatic digestion, or in the intact form using High-Resolution Mass Spectrometry (HRMS).

Validation of bioanalytical methods is performed in compliance with international standards (ICH M10).

ICON offers a range of state-of-the-art Sciex mass spectrometers, ranging from API5000 to API6500+ and API 7500 instruments. Our laboratory in Assen also has a API6600 High-Resolution mass spectrometer (HRMS).

 

Services include:

  • Method transfer
  • Full method development
  • Method validation
  • Support of pre-clinical animal studies
  • Support of clinical trials (Phase 1 through 4)
  • Bioavailability studies
  • Bioequivalence studies
  • Drug-drug interaction studies
  • Microsampling (Wet and dried samples)
  • Metabolite screening & identification
  • Biohazard laboratory for infectious samples
  • Biomarker analysis
  • Protein binding studies

 

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