该评估有逾250名参与者证明Loop在血压、心率、氧饱和度、呼吸和二氧化碳监测等标准的临床等效性(clinical equivalence)。Spry Health已经向美国食品药品监督管理局(FDA)提交审核,希望在2018年初获准让Loop上市。
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结论这种方法适用于以治疗对照差临床意义研究或临床等效性为目的临床试验的设计。
Conclusion it is appropriate with the planning for clinical trials aimed at clinical significance of treatment-control difference or clinical equivalence. An example illustrates the methodology.
结论:对于以建立治疗-对照差临床意义或临床等效性为目的的分层两组临床试验,可用该检验进行分析。
Conclusion: the test can be applied to analyzing the data from the clinical trials for establishing the clinical significance of treatment-control difference or clinical equivalence.
生物等效性试验结果(在健康自愿者身上进行临床试验),除非放弃要求。
Results of bioequivalence tests (clinical trials conducted in healthy volunteers), unless waived.
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