New Chemical Entities (NCE)
Our method development team consists of experienced scientists dedicated to method development. Our extensive experience in the development of new chemical entities (NCE), bioanalytical methods and our state-of-the-art instrumentation have allowed us to achieve:
- Extremely low LLOQ
- Low sample volume
- Large dynamic ranges
- Quantification of multiple metabolites
One of our main focuses during method development is to have methods that are free of interference from metabolites. In collaboration with our sponsors, we perform thorough literature research and a review of the investigator brochure to determine the presence of potentially unstable metabolites. If no information on metabolites is available at the pre-clinical stage, investigation with the animal samples will be done to evaluate the presence of suspected metabolites. Our goal with this procedure is to ensure that our reported results are not biased by the presence of a metabolite. Also, in the correct circumstances, metabolite testing is performed using authentic reference standards.
Once a method is ready for validation and sample analysis, a special team is dedicated to the NCE work in order continue the relationship established during method development. All work is conducted to GLP standards and current regulatory guidelines. If required, our standards can be modified to suit your needs.
