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TOOL FOR IN VITRO-IN VIVO CORRELATION

机译:体外体内相关工具

摘要

A kind of biological response data in the system and method computer-assisted analysis of biological modelling enhancing provide information synthesis from immediately with extend the data with release in vitro data in vivo. The information of eXecute UML and the data that basis is developed from biosystem. In a preferred embodiment, two stage approach is to modeling for developing IVIVC. The first stage of the process is deconvolution, is determined in the percentage of drug absorption. In second stage, by data and body absorption percentage associated score or percentage and dissolution in vitro data. The correlation then indicate point-to-point between relationship and In Vitro Dissolution and internal input rate drug from dosage form, this correlation, In Vitro Dissolution and body absorption section or directly stackable or the stackable use ratio factor can be made. It deconvolutes before the stage, concentration-data can be released immediately from unit impulse response function. This impulse response function determines the extended release formulation of body absorption percentage for the Method of Deconvolution. Nonlinear IV IVC models are developed, and that can incorporate time-scaling into own forces and the time is transferred into model, if necessary. Two-stage modeling in such a way is completed, and prediction exploitation IVIVC assessment models are by verifying inside and outside two.
机译:该系统中的一种生物响应数据和计算机辅助生物建模分析的方法增强了从扩展数据到体内释放体外数据的即时信息合成。 eXecute UML的信息和依据的数据是从生物系统开发的。在优选实施例中,两阶段方法是建模以开发IVIVC。该过程的第一阶段是反卷积,取决于药物吸收的百分比。在第二阶段,通过数据与人体吸收百分比相关的分数或体外溶出百分比数据。然后,该相关性指示剂型与体外溶出度和药物内部输入速率之间的关系之间的点对点关系,该相关性,体外溶出度和人体吸收部分或可直接堆叠或可堆叠使用比率因子均可制成。它可以在阶段之前进行解卷积,可以立即从单位脉冲响应功能中释放浓度数据。该脉冲响应函数确定了反卷积方法的人体吸收百分比的延长释放形式。开发了非线性IV IVC模型,可以将时间标度合并到自己的力中,如果需要,可以将时间转移到模型中。这样完成了两阶段建模,并且通过对两个内部和外部进行验证来进行预测开发IVIVC评估模型。

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