DDSolver:一款用于药物溶出曲线建模和比较的插件程序。
DDSolver: an add-in program for modeling and comparison of drug dissolution profiles.
机构信息
Department of Pharmaceutics, China Pharmaceutical University, No. 24, Tongjiaxiang, 210009 Nanjing, China.
出版信息
AAPS J. 2010 Sep;12(3):263-71. doi: 10.1208/s12248-010-9185-1. Epub 2010 Apr 6.
In recent years, several mathematical models have been developed for analysis of drug dissolution data, and many different mathematical approaches have been proposed to assess the similarity between two drug dissolution profiles. However, until now, no computer program has been reported for simplifying the calculations involved in the modeling and comparison of dissolution profiles. The purposes of this article are: (1) to describe the development of a software program, called DDSolver, for facilitating the assessment of similarity between drug dissolution data; (2) to establish a model library for fitting dissolution data using a nonlinear optimization method; and (3) to provide a brief review of available approaches for comparing drug dissolution profiles. DDSolver is a freely available program which is capable of performing most existing techniques for comparing drug release data, including exploratory data analysis, univariate ANOVA, ratio test procedures, the difference factor f (1), the similarity factor f (2), the Rescigno indices, the 90% confidence interval (CI) of difference method, the multivariate statistical distance method, the model-dependent method, the bootstrap f (2) method, and Chow and Ki's time series method. Sample runs of the program demonstrated that the results were satisfactory, and DDSolver could be served as a useful tool for dissolution data analysis.
近年来,已经开发了几种用于分析药物溶出数据的数学模型,并且提出了许多不同的数学方法来评估两种药物溶出曲线之间的相似性。然而,到目前为止,还没有报道用于简化建模和比较溶出曲线所涉及的计算的计算机程序。本文的目的是:(1) 描述一种名为 DDSolver 的软件程序的开发,用于促进药物溶出数据相似性的评估;(2) 建立一个使用非线性优化方法拟合溶出数据的模型库;(3) 简要回顾比较药物溶出曲线的现有方法。DDSolver 是一个免费提供的程序,能够执行比较药物释放数据的大多数现有技术,包括探索性数据分析、单变量方差分析、比率检验程序、差异因子 f(1)、相似因子 f(2)、Rescigno 指数、差异方法的 90%置信区间 (CI)、多变量统计距离方法、基于模型的方法、自举 f(2)方法和 Chow 和 Ki 的时间序列方法。程序的示例运行表明结果令人满意,DDSolver 可以作为溶出数据分析的有用工具。