The Bioanalytical services department at Algorithme Pharma has years of experience in innovative method development including complex molecule and metabolite testing using animal studies. Our strength is our partnership with clients. A direct relationship is established at the inception of method development, with the scientist responsible for the method, and continues throughout the process.
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 a thorough literature research and review of the investigator brochure to determine the presence of potentially unstable metabolites. If no information on metabolites is available at the preclinical stage, investigation with the samples will be done to determine 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 that could convert to the analyte of interest.
Once a method is ready for validation and sample analysis, a special team is dedicated to the preclinical work in order to continue the relationship established during method development. All work is conducted in compliance with GLP standards and current regulatory guidelines.