Pharmacometrics
"We are clinical pharmacologists and drug developers with innate ability to aid in solving drug development challenges and developing straight forward strategies for successful therapies."
We utilize modeling and simulation throughout the drug development process to help decrease risk for your programs and support important milestone decisions. Pharmacometrics allows us to quantify the interactions between drugs and patients by linking the biology, physiology, and pharmacology of the disease state through mathematical and statistical models. These pharmacometrics models are built using data from both internal preclinical and clinical data, as well as external data on competitor drugs of the same class. We utilize pharmacometrics analyses to provide insight into the characteristics of the compound, and how it may interact within various species, including humans.
Pharmacometrics has become a very important piece of the total drug development package starting in early development and continuing through clinical trials. It can allow for the prediction of pharmacokinetics in various species based on early data, be used to guide and support dose selection rationales, and establish relationships between pharmacokinetics and patient demographics using sparse data. We can also use pharmacometrics to explore and quantify the pharmacodynamics and effect of a compound. Using a population pharmacokinetic/pharmacodynamic model, we can link the exposure of a drug with its effect, even in early stages of development. An example of this includes preclinical tumor modeling, where a prediction of the antitumor effect of a compound can be generated based on preclinical tumor efficacy and pharmacokinetic studies. Further exposure/response or exposure/safety analyses can also be conducted to justify dose selection and are critical in seeking regulatory approval.
Our Pharmacometrics Services:
• Creation of population pharmacokinetic models in animal species and humans
• Prediction of human pharmacokinetics based on animal population pharmacokinetic models
• Dosing simulations for various regimens, patient groups, and dosing scenarios
• Covariate analysis of various demographic and physiological factors on the pharmacokinetics and pharmacodynamics of a compound
• Creation of population pharmacodynamic models in animal species and humans
• Human tumor effect predictions based on preclinical tumor modeling
• Exposure/response and exposure/safety analyses
