PK/PD modeling (pharmacokinetic/pharmacodynamic modeling) (alternatively abbreviated as PKPD [1] or PK-PD [2] modeling) is a technique that combines the two classical pharmacologic disciplines of pharmacokinetics and pharmacodynamics. [3] It integrates a pharmacokinetic and a pharmacodynamic model component into one set of mathematical expressions that allows the description of the time course of effect intensity in response to administration of a drug dose. PK/PD modeling is related to the field of pharmacometrics.
Central to PK/PD models is the concentration-effect or exposure-response relationship. [4] A variety of PK/PD modeling approaches exist to describe exposure-response relationships. PK/PD relationships can be described by simple equations such as linear model, Emax model or sigmoid Emax model. [5] However, if a delay is observed between the drug administration and the drug effect, a temporal dissociation needs to be taken into account and more complex models exist: [6] [7]
PK/PD modeling has its importance at each step of the drug development [9] [10] and it has shown its usefulness in many diseases. [11] The Food and Drug Administration also provides guidances for Industry to recommend how exposure-response studies should be performed. [12]
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