Regulations of Bioavailability and Bioequivalence Studies Article 20
Bioequivalence study between two products can be substituted with bioavailability and clinical studies. In principle, bioequivalence studies are preferred. If a substitute (i.e., the bioavailability combined with clinical studies) is preformed; the clinical trials should demonstrate with statistical significance.
中文原文 藥品生體可用率及生體相等性試驗作業準則第20條
二種藥品之生體相等性比較，得以生體可用率試驗連同臨床試驗替代。
但原則上以生體相等性試驗為優先。
如以生體可用率試驗連同臨床試驗替代者，所執行之臨床試驗，應具有統計顯著（StatisticalSignificance）之意義。
但原則上以生體相等性試驗為優先。
如以生體可用率試驗連同臨床試驗替代者，所執行之臨床試驗，應具有統計顯著（StatisticalSignificance）之意義。