Population Pharmacokinetics (Population PK) is the study of variability in drug concentrations among individuals in the target patient population receiving clinically relevant doses of a drug of interest.
Population PK involves collecting sparse PK samples (e.g., plasma drug concentration) from many patients in clinical studies (i.e., the population) and the use of a population PK model to analyze the data. In comparison, clinical pharmacology or healthy volunteer studies typically collect dense PK samples from small numbers of subjects. Population PK begins with development of a model describing the pharmacokinetic behavior of a given drug in humans.
In contrast to traditional pharmacokinetic evaluation, the Population PK approach encompasses some or all of the following features:
- Understanding relevant pharmacokinetic information in patients who are representative of the target population to be treated with the drug.
- The identification and measurement of variability during drug development and evaluation.
- The explanation of variability by identifying factors of demographic, pathophysiological, environmental, or concomitant drug-related origin that may influence the pharmacokinetic behavior of a drug.
- The quantitative estimation of the magnitude of the unexplained variability in the patient population.
- Correlation of PK concentrations to pharmacodynamic (PD and PK/PD) response.
All of these components are required during the FDA’s evaluation of a drug for marketing authorization (NDA or BLA).
Nuventra has an expert team of pharmacometricians led by our Senior Vice President of Modeling and Simulation, Mark Sale, MD. We take complex population PK analyses and make them understandable and usable for common sense drug development.
Our Population PK Services:
- NONMEM datasets
- Population PK model generation, development, and refinement
- Identify & confirm predictive covariates
- Modeling & simulation to support Population PK/PD
- Parallel NONMEM to decrease run time for complex models
- Automated modeling selection using DARWIN
- Dose selection and justification
- Exposure-response analysis
- Concentration QT (cQT) modeling
- Submission-ready Population PK report writing