Regulations of Bioavailability and Bioequivalence Studies Article 22
Instruments and analytical methods used for dissolution profile comparison shall be documented for system suitability and analytical methods validation, respectively.
中文原文 藥品生體可用率及生體相等性試驗作業準則第22條
執行溶離曲線比對試驗所用之設備及分析方法，應檢具所用溶離裝置之系統適用性（SystemSuitability）及定量分析方法確效（AnalyticalMethodsValidation）之資料。