Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Crossover Experiments
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioequivalence studies: Biowaivers
Bioequivalence: Overview
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David Hinds1, Stella Grosser1, Wanjie Sun1
1Center for Drug Evaluation and Research, Silver Spring, MD, USA.
本研究引入了用于控制仿制药生物等价性 (BE) 测试中的统计学意义的改进方法. 修订后的Bonferroni,Holm和Hochberg方法在三向交叉BE研究中提高了功率并减少了样本大小.
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