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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Ignorability and parameter estimation in longitudinal pharmacokinetic studies.
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Ignorability and parameter estimation in longitudinal pharmacokinetic studies.

机译：纵向药代动力学研究中的不可知性和参数估计。

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摘要

In the analysis of longitudinal pharmacokinetic data, both balanced (equal number of samples per subject) and unbalanced data are used. It is implicitly assumed that the process that caused the missing data can be ignored. A simulation study was performed to determine the effect of ignoring the missing data (i.e., "ignorability") on the accuracy and precision of parameter estimation in longitudinal pharmacokinetic studies. A two-compartment model with multiple intravenous bolus inputs was assumed. Subjects with balanced data sets had six samples, and those with unbalanced data had 1 to 5 samples missing (i.e., supplied in a decreasing order from 5 to 1 samples). The proportion of subjects with 1 to 5 samples missing varied from 25% to 75% in a fixed sample size of 100. The effect of ignorability was studied at intersubject variability ranging from 15% to 60% for a drug assumed to be dosed at its elimination half-life. One hundred replicate data sets of 100 subjects each were simulated for each missing data scenario. The accuracy of parameter estimation was not significantly affected by the amount of ignorable missing data at any given level of variability. However, the precision of parameter estimation was affected by the degree of "missingness."
机译：在纵向药代动力学数据的分析中，使用了平衡（每个受试者的样本数量相等）和不平衡数据。隐式假定可以忽略导致丢失数据的过程。进行模拟研究以确定忽略缺失数据（即“可忽略性”）对纵向药代动力学研究中参数估计的准确性和精确性的影响。假设有多室静脉推注输入的两室模型。具有平衡数据集的受试者有六个样本，而具有不平衡数据的受试者则缺少1-5个样本（即以从5到1个样本的降序排列）。在固定样本量为100的情况下，缺少1至5个样本的受试者比例从25％到75％不等。对于假定以其剂量给药的药物，受试者间变异性在15％至60％的范围内研究了可燃性的影响。消除半衰期。针对每种丢失的数据场景，模拟了100个主题分别为100个的重复数据集。在任何给定的可变性水平下，参数估计的准确性不受可忽略的缺失数据量的显着影响。但是，参数估计的精度受“缺失”程度的影响。

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