Regulations of Bioavailability and Bioequivalence Studies Article 2
The execution of bioavailability and bioequivalence and their related studies shall comply with the provisions of the Regulation. Matters not provided for herein should be governed by the Guidelines of Good Clinical Practice, the Regulation for Registration of Medicinal Products, and other relevant laws and regulations.
中文原文 藥品生體可用率及生體相等性試驗作業準則第2條
藥品生體可用率與生體相等性及有關試驗之執行，應符合本準則之規定；本準則未規定者，依藥品優良臨床試驗準則、藥品查驗登記審查準則及其他有關法令之規定。