Population PK (popPK) analyses are a crucial aspect of almost all drug development programs. Because of the growing emphasis placed on popPK analyses by regulatory authorities, and the wealth of information that these analyses provide, it is more important than ever to consider how popPK fits into your own drug development program.
Allucent has an expert team of pharmacometricians who take complex population PK analyses and distill them into the critical insights that drive common-sense drug development. Population PK analysis can be completed during early to mid-stage clinical development or at later stages of development to fit your program needs.
What is Population PK?
Population pharmacokinetics, also referred to as population PK or popPK, is used to understand the variability in drug concentrations among individuals in a group of interest (the “population”). Patient characteristics (“covariates”), such as age, disease state, demographics, sex, concomitant medications, or presence of renal or hepatic impairment, can affect a drug’s pharmacokinetics (PK) and pharmacodynamics (PD). Understanding this variability can help establish a robust PK/PD profile and inform safe and effective dosing regimens.
PopPK analysis involves collecting sparse PK samples (i.e., drug concentration data) from many patients and often across multiple clinical studies, and then building mathematical models to describe those data. Using sparse PK sampling, only a limited number of samples are taken from any given patient. With appropriate sampling design and model selection, the resulting PK data can be pooled and analyzed to support conclusions about PK variability and the influence of covariates.
Population PK Services:
- Expert advice on study design, including protocol and analysis plan development
- NONMEM datasets
- Population PK model generation, development, and refinement
- Identification & confirmation of predictive covariates
- Modeling & simulation to support population PK/PD
- Parallel NONMEM to decrease run time for complex models
- Dose selection and justification
- Exposure-response analysis
- Concentration QT (cQT) modeling
- Submission-ready population PK report writing