For several years now, PopPK has taken an essential place in the drug development program and can be applied at all phases of drug development, adapting each time to clinical constraints. The agencies encourage more and more the use of popPK modelling to inform drug development and use. Indeed, The US Food and Drug Administration (FDA) released new draft guidance on Population Pharmacokinetics (PopPK) in July of 2019.
Population pharmacokinetics (PopPK) modeling is a part of the major expertise activities at PhinC Development and consists of describing the behavior of a drug not at the individual level but in the overall population and allows to quantify the variability that may exist between individuals in the same population or from one population to another and to identify the source of this variability.
This sophisticated analysis gathering all your clinical data and using statistical algorithms allows you to consider all subjects and all timing points.
PopPK allows accurate estimates in:
- Various subject groups, e.g. body, weight, gender, impaired organs, etc.
- Source variability, e.g. food, co-med, time of the day, etc.
- Special population analysis, e.g. elderly, obese, hepatic impairment, renal insufficiency, children, etc.
Using these tools in targeted exposure will lead to:
- Identifying relevant covariates in patients
- Simulating exposure, predicting therapeutic dose, anticipating activity for special populations
- Saving you dedicated studies in special populations
- Coverage of proper dose range
- Phases II and III dose selection rational strength for regulatory authorities