Regulations of Bioavailability and Bioequivalence Studies Article 4
Pharmaceutical manufacturers must apply for the approval of the protocol from the central competent health authority before conducting bioavailability and bioequivalence studies. The content of studies should comply with the Guideline of Good Clinical Practices. However, the application of protocol for conducting bioavailability and bioequivalence studies of generic drugs can be waived.
中文原文 藥品生體可用率及生體相等性試驗作業準則第4條
執行生體可用率及生體相等性試驗之前，藥商應向中央衛生主管機關申請核定計畫，其試驗計畫書之內容，應符合藥品優良臨床試驗準則之規定。
但學名藥之生體可用率及生體相等性試驗計畫書，得免事先申請。
但學名藥之生體可用率及生體相等性試驗計畫書，得免事先申請。