Pharmacometric Applications in Drug Development and Individualization of Drug Therapy
Mohsen A. Hedaya · 2023
Pharmacometrics involves the utilization of mathematical and statistical modeling approaches to characterize and predict the drug dose-concentration-effect relationship in different populations. This area has been evolving over the years due to the advancement in data analysis approaches and the availability of specialized data analysis software. The pharmacometrics principles can be applied during the drug development process and in the optimization of patient pharmacotherapy. A large amount of data is generated during the drug development process. Application of innovative modeling approaches can extract valuable knowledge from these data. This can result in speeding and decreasing the cost of the drug development process. The different pharmacokinetic-pharmacodynamic modeling approaches have been utilized during the preclinical and clinical phases of drug development to characterize the drug dose-exposure-response relationship. The physiologically based pharmacokinetic models have been used during the preclinical phase of drug development to describe the drug exposure-response relationship in specific organ, to predict the drug pharmacokinetic behavior in humans, and to estimate the first-in-human drug dose. The knowledge gained from population modeling during clinical trials is used to develop dosage recommendations for the different patient populations. Also, population modeling can be applied to the data obtained during therapeutic drug monitoring for the optimization of therapeutic outcome.