The strategic location of a bioanalytical laboratory close to the clinical research units of the Netherlands Cancer Institute facilitates the support of clinical studies with anticancer drugs with time-critical samples to be analyzed (rapid turnaround times for dose escalation studies and therapeutic drug monitoring) and of mass balance studies preventing the shipment of radioactive samples. The co-located clinical research units enables innovative working collaboration with clinicians, efficient analysis and faster progress of clinical studies leading to a reduction in the costs.
• Development, validation and implementation of bioanalytical methods
• Transfer and cross validation of bioanalytical methods
• Bioanalysis of samples from clinical studies and pre-clinical studies
• Long-term stability evaluations
• Preparation of Bioanalytical Reports and Validation Reports (to standard templates or customized)
• Electronic transfer of data according to the specifications of the sponsor
• Toxicology studies
• Early to late phase clinical trials (phase I - IV)
• Mass Balance and Metabolite Profiling Studies
• Microdosing studies
• Bioavailability studies
• Bioequivalence studies
• Food effect studies
• Drug interaction studies
• Therapeutic drug monitoring
Our bioanalytical group is comprised of specialists with over 25 years of experience in bioanalysis, cooperation with sponsors and clinics. Our employees are specialized in the development of bioanalytical methods for complex anticancer drugs. We offer validated methods for the quantification of anticancer drugs that are ready for use, including ultra-sensitive methods down to lower limits of quantification of pg/mL in body fluids and methods for the quantification of anticancer drugs in other matrices (PBMCs, tumor tissues and DNA).
Validation criteria follow guidelines from the FDA and EMA. All validations are tailored for the support of specific studies. We have an independent QA group responsible for facility, process and study audits.
