Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
}
TY - JOUR
T1 - Non-compartmental estimation of pharmacokinetic parameters in serial sampling designs.
AU - Wolfsegger, Martin J.
AU - Jaki, Thomas
PY - 2009/10
Y1 - 2009/10
N2 - Pharmacokinetic studies are commonly analyzed using a two-stage approach where the first stage involves estimation of pharmacokinetic parameters for each subject separately and the second stage uses the individual parameter estimates for statistical inference. This two-stage approach is not applicable in sparse sampling situations where only one sample is available per subject. Nonlinear models are often applied to analyze pharmacokinetic data assessed in such serial sampling designs. Modelling approaches are suitable provided that the form of the true model is known, which is rarely the case in early stages of drug development. This paper presents an alternative approach to estimate pharmacokinetic parameters based on non-compartmental and asymptotic theory in the case of serial sampling when a drug is given as an intravenous bolus. The statistical properties of the estimators of the pharmacokinetic parameters are investigated and evaluated using Monte Carlo simulations.
AB - Pharmacokinetic studies are commonly analyzed using a two-stage approach where the first stage involves estimation of pharmacokinetic parameters for each subject separately and the second stage uses the individual parameter estimates for statistical inference. This two-stage approach is not applicable in sparse sampling situations where only one sample is available per subject. Nonlinear models are often applied to analyze pharmacokinetic data assessed in such serial sampling designs. Modelling approaches are suitable provided that the form of the true model is known, which is rarely the case in early stages of drug development. This paper presents an alternative approach to estimate pharmacokinetic parameters based on non-compartmental and asymptotic theory in the case of serial sampling when a drug is given as an intravenous bolus. The statistical properties of the estimators of the pharmacokinetic parameters are investigated and evaluated using Monte Carlo simulations.
KW - Asymptotic - Non-compartmental - Pharmacokinetics - PK parameters - Serial sampling - Sparse sampling
U2 - 10.1007/s10928-009-9133-9
DO - 10.1007/s10928-009-9133-9
M3 - Journal article
VL - 36
SP - 479
EP - 494
JO - Journal of Pharmacokinetics and Pharmacodynamics
JF - Journal of Pharmacokinetics and Pharmacodynamics
SN - 1573-8744
IS - 5
ER -