QPS recognizes the importance of well-conducted clinical trials on drug-drug interactions. Historically, the CYP450 interactions provided valuable information for the safe use of drugs, being an inhibitor, inducer or substrate of one or more of the CYP isoenzymes. In addition, studies on phenotyping-genotyping helped to understand the behavior of a number of drugs in genetically diverse subpopulations. QPS’ VP & Global Head of Early Phase Clinical, Dr Wim Tamminga, is an expert within this area.
Over the years, the FDA and EMA have issued guidelines on DDI interactions, both for pre-clinical and clinical research. This was an evolutionary enterprise because of the continuous identification of new metabolic routes and proteins. Presently, there is a strong focus on DDI in which drug transporters play an important role and the QPS Team of scientists and clinical pharmacologists has been involved in designing clinical trials on these DDI interactions. Our strategy is to make such trials as efficient as possible by e.g., combining transporter DDI components into one study protocol, or even dosing transporter substrates simultaneously.
The QPS scientific teams have started a collaboration with Professor Bob Wilfert, pharmacist at the University of Groningen The Netherlands and internationally recognized expert in the field, on an exciting research project on genotyping/phenotyping the transporter characteristics of participants in our clinical studies. The aim is to build a database with fully characterized subjects, which will allow us to enroll subpopulations in DDI studies and correlate the various genotypes of CYP450 enzymes and/or transporters with the pharmacokinetics features of a drug. QPS GLP certified labs are involved in this project by extending the number of assays necessary for genotyping our study subjects.
Staying at the forefront of innovation, QPS aims to be a pro-active and supportive partner in our clients’ needs, defining the drug’s metabolic and pharmacokinetic characteristics and shaping a smooth transition at each step of the dossier development process. Please contact the QPS Business Development Team ([email protected]), or Edwin van Vulpen, Senior Director BD, for further information. We will be happy to get started on the successful delivery of your compound through this challenging area.
Peter Dogterom, PhD, Director Clinical Pharmacology
Wim Tamminga, PhD, VP & Global Head of Early Phase Clinical