What is Pharmacometrics?
Pharmacometrics is a quantitative approach to the analysis and interpretation of pre-clinical and clinical trial data. This discipline uses mathematical and statistical models, based upon the principles of clinical pharmacology, to represent the complex processes of how a drug and the body interact. Pharmacometric models may be used to estimate and predict physiological and/or pathophysiological processes, the progression of a disease out over time, drug exposure, drug action, and clinical outcomes. Factors effecting the variability in a drug’s pharmacokinetic and pharmacodynamic profile may be identified using these techniques to optimize (individual) dosing regimens for safety and efficacy. Successful drug development utilizes pharmacometrics to drive the decision making process.
How does Pharmacometrics Work?
Pharmacometrics helps optimize (individual) dosing regimens by predicting drug concentrations for dose adjustment. By fine-tuning the dosing regimen to get drug concentrations within the therapeutic window, we can minimize the potential risk of adverse events and improve efficacy. Correspondingly, this also helps improve the efficiency and cost-effectiveness of clinical trials and the overall development process.
One of the key pharmacometric techniques is to identify and account for variability due to patient factors (eg, weight, renal / hepatic function, or phenotype) influencing drug exposures or clinical response. This allows for identification of special patient sub-populations, whereby dose adjustment or more targeted clinical trials may be needed.
What are the Overall Benefits of Pharmacometrics?
Pharmacometrics derives its value by empowering drug developers to conduct efficient, cost-effective clinical trials. The development of pharmacometric models enables researchers to simulate various scenarios, in silico, for determination of the best study design, population, dosing regimen, and analysis methodology. This approach optimizes the time, cost, and quality of conducting clinical trials to give each molecule the best chance of success.
Similarly, in the post-marketing phase of drug development, pharmacometrics is being increasingly used to monitor drug safety and efficacy. By utilizing data available from electronic health records and other sources, pharmacometricians are able to identify potential adverse events and drug interactions, while providing optimized dosing regimens for these special patient populations.
Extensions of pharmacometrics may also be found in pharmacoeconomics, where setting drug prices, estimating a developer’s return on investment, or predicting the economic impact a particular drug may have on society may be obtained.
Overall, pharmacometrics is a robust field that plays a fundamental role throughout the drug development process.