Koehne-Voss Stephan, Pigeot Iris
Novartis Pharma AG, Basel, Switzerland.
Biom J. 2009 Feb;51(1):146-58. doi: 10.1002/bimj.200710498.
Procedures for deconvolution of pharmacokinetic data are routinely used in the pharmaceutical industry to determine drug release and absorption which is essential in designing optimized drug formulations. Although these procedures are described extensively in the pharmacokinetic literature, they have been studied less from a statistical point of view and variance estimation has not been addressed. We discuss the statistical properties of a numerical procedure for deconvolution. Based on a point-area deconvolution method we define an estimator for the function that describes the time course of drug release from a drug formulation. Asymptotic distributions are derived and several methods of variance and interval estimation are compared.
药代动力学数据反卷积程序在制药行业中经常用于确定药物释放和吸收情况,这对于设计优化药物制剂至关重要。尽管这些程序在药代动力学文献中有广泛描述,但从统计学角度对其研究较少,且尚未涉及方差估计问题。我们讨论了一种反卷积数值程序的统计特性。基于点面积反卷积方法,我们定义了一个用于描述药物制剂中药物释放时间过程的函数的估计量。推导了渐近分布,并比较了几种方差和区间估计方法。