Preclinical Studies

For your preclinical studies, you need a partner that provides strong bioanalytical support. 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.  

If you like, your pre-clinical methods can be transferred from sponsor laboratories, and feasibility studies can be performed to confirm suitability of the method. Also, utilisation of Dried Blood Spot analysis (DBS) is an interesting alternative for all the preclinical work to reduce the sample volume required for analysis.

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 pre-clinical stage, investigation with the animal 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. Also, whenever possible, the 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 pre-clinical work in order to continue the relationship established during method development. All work is conducted in compliance with GLP standards and current regulatory guidelines. If required, our standards can be modified to suit your needs.