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