Sec. 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study单剂量体内生物利用度或生物等效性研究指南 （a）Basic principles.（a）基本原则： (1) An in vivo bioavailability or bioequivalence study should be a single-dose comparison of the drug product to be tested and the appropriate reference material conducted in normal adults.（1）体内生物利用度或生物等效性研究应在正常成人体内将待测药品与参比制剂进行单剂量比较。 (2) The test product and the reference material should be administered to subjects in the fasting state, unless some other approach is more appropriate for valid scientific reasons.（2）受试者应在禁食状态下服用测试产品与参比制剂，除非有其他更有效的科学依据。 （b） Study design.（b）研究设计。 (1) A single
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