Kinetics (pharmacokinetics and pharmacodynamics)
Kinetics, in health research and drug development, refers to the study of rates of change over time: how quickly a drug is absorbed, distributed, metabolised and eliminated (pharmacokinetics, PK), how the concentration of the drug at its site of action translates into effect over time (pharmacodynamics, PD), and, in the underlying chemistry, the rate at which reactions such as enzymatic metabolism proceed. PK/PD modelling links these to identify dose regimens that achieve therapeutic exposure with acceptable toxicity.
Kinetic data is generated in Phase I trials through intensive blood sampling schedules, in later phases through sparse sampling analysed with population pharmacokinetic methods, and increasingly through model-informed drug development accepted by the EMA and FDA in place of some dedicated studies. Results feed the investigator's brochure, the IMPD and the clinical pharmacology section of the marketing application.
Kinetic datasets are individual-level health data: timed concentrations, body weight, renal and hepatic function, and frequently pharmacogenomic variants that explain metabolic differences. Samples are often analysed by a specialised bioanalytical laboratory acting as a processor, and residual samples may be banked for future assays. The associated data flows, retention of samples and future-use consent should be described in the DPIA and informed consent form like any other trial data.
Pharmacokinetics describes how drug concentrations change over time, while pharmacodynamics concerns the drug’s effects. Linking them helps assess how exposure relates to response. In a study dataset, accurate dose and sample times are therefore important alongside outcome measurements; a concentration value without its timing context can be difficult to interpret.
Request our booklet
See how we can help you via our comprehensive program,
set of tools and services.
