They describe both population and subject‐specific characteristics, represented as fixed parameters for population characteristics and random parameters for subjects. 1, 2, 3 NLMEM for continuous PK/PD data use nonlinear dynamic models that draw on physiological or pharmacological principles to provide a reasonable approximation of the dynamics of the drug in the body and of their effects. Nonlinear mixed effects models (NLMEMs) have been established as the state of the art methodology in pharmacometrics for analysis of longitudinal pharmacokinetic (PK) and pharmacodynamic (PD) measurements collected in preclinical and clinical studies, especially in drug development.
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