控释制剂中体内外相关性研究的两种方法

Two Technique of In Vitro/In Vivo Correlation for Controlled Release Dosage Form

制剂的体内外相关性研究对制剂开发特别是控释制剂的开发极为重要。对得到较高水平的相关性参数的方法——统计矩分析及线性系统分析进行了论述,着重论述了卷积法在相关性研究中的应用。

Search for an in vitro/in vivo correlation of Pharmaceuticals is an important and challenging task in formulation development, especially for controlled-release dosage form. In this paper, the methods of obtaining parameters for high levels of correlation are presented with emphasis on linear system analysis.