Methods Inf Med - Limited sampling strategies to estimate the area under the concentration-time curve. Biases and a proposed more accurate method.


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CKGROUND: Over 100 limited sampling strategies (LSSs) have been proposed to reduce the number of blood samples necessary to estimate the area under the concentration-time curve (AUC). The conditions under which these strategies succeed or fail remain to be clarified.OBJECTIVES: We investigated the accuracy of existing LSSs both theoretically and numerically by Monte Carlo simulation. We also proposed two new methods for more accurate AUC estimations.METHODS: We evaluated the following existing methods theoretically: i) nonlinear curve fitting algorithm (NLF), ii) the trapezium rule with exponential curve approximation (TZE), and iii) multiple linear regression (MLR). Taking busulfan (BU) as a test drug, we generated a set of theoretical concentration-time curves based on the identified distribution of pharmacokinetic parameters of BU and re-evaluated the existing LSSs using these virtual validation profiles. Based on the evaluation results, we improved the TZE so that unrealistic parameter values were not used. We also proposed a new estimation method in which the most likely curve was selected from a set of pre-generated theoretical concentration-time curves.RESULTS: Our evaluation, based on clinical profiles and a virtual validation set, revealed: i) NLF sometimes overestimated the absorption rate constant Ka, ii) TZE overestimated AUC over 280% when Ka is small, and iii) MLR underestimated AUC over 30% when the elimination rate constant Ke is small. These results were consistent with our mathematical evaluations for these methods. In contrast, our two new methods had little bias and good precision.CONCLUSIONS: Our investigation revealed that existing LSSs induce different but specific biases in the estimation of AUC. Our two new LSSs, a modified TZE and one using model concentration-time curves, provided accurate and precise estimations of AUC.

Resumo Limpo

ckground limit sampl strategi lsss propos reduc number blood sampl necessari estim area concentrationtim curv auc condit strategi succeed fail remain clarifiedobject investig accuraci exist lsss theoret numer mont carlo simul also propos two new method accur auc estimationsmethod evalu follow exist method theoret nonlinear curv fit algorithm nlf ii trapezium rule exponenti curv approxim tze iii multipl linear regress mlr take busulfan bu test drug generat set theoret concentrationtim curv base identifi distribut pharmacokinet paramet bu reevalu exist lsss use virtual valid profil base evalu result improv tze unrealist paramet valu use also propos new estim method like curv select set pregener theoret concentrationtim curvesresult evalu base clinic profil virtual valid set reveal nlf sometim overestim absorpt rate constant ka ii tze overestim auc ka small iii mlr underestim auc elimin rate constant ke small result consist mathemat evalu method contrast two new method littl bias good precisionconclus investig reveal exist lsss induc differ specif bias estim auc two new lsss modifi tze one use model concentrationtim curv provid accur precis estim auc

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