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首页> 外国专利> TOOL FOR IN VITRO-IN VIVO CORRELATION

TOOL FOR IN VITRO-IN VIVO CORRELATION

机译：体外体内相关工具

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摘要

A biological modeling system and method for enhanced computer-aided analysis of biological response data provides information synthesized from immediate and extended release in vivo data and in vitro data. An executable model of a biological system is developed from information and structures based on the data. In a preferred embodiment, a two stage approach to modeling is used in the development of an IVIVC. The first stage of the procedure is deconvolution, where the percentage of drug absorbed is determined. In the second stage, the in vivo percentage absorbed data is correlated to the in vitro fraction or percentage dissolved data. This correlation then represents a point-to-point relationship between the in vitro dissolution and the in vivo input rate of the drug from the dosage form. In such a correlation, the in vitro dissolution and in vivo absorption profiles are either directly superimposable or may be made to be superimposable by the use of a scaling factor. Prior to the deconvolution stage, a unit impulse response function can be determined from immediate-release concentration-time data. This impulse response function is used in the deconvolution process to determine the in vivo percent absorbed for the extended release formulations. A nonlinear IVIVC model is developed that can incorporate time-scaling and time-shifting into the model if needed. After the two-stage modeling is completed, the predictability of the developed IVIVC model is evaluated by both internal and external validation.
机译：用于增强的计算机辅助生物反应数据分析的生物建模系统和方法可提供从即时和延长释放的体内数据和体外数据合成的信息。根据数据，从信息和结构中开发出生物系统的可执行模型。在优选实施例中，在IVIVC的开发中使用了两阶段建模方法。程序的第一阶段是反卷积，确定吸收的药物百分比。在第二阶段，体内吸收百分比数据与体外分数或溶解百分比数据相关。然后，该相关性代表药物从剂型的体外溶出度与药物的体内输入速率之间的点对点关系。以这种相关性，体外溶出度和体内吸收曲线可以直接叠加，也可以通过使用缩放因子使其叠加。在去卷积阶段之前，可以从速释浓度时间数据确定单位脉冲响应函数。在反卷积过程中使用此脉冲响应函数来确定缓释制剂的体内吸收百分比。开发了一个非线性IVIVC模型，可以在需要时将时标和时移纳入模型。两阶段建模完成后，将通过内部和外部验证来评估已开发的IVIVC模型的可预测性。

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