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Interval test for efficiency evaluation of new medicine
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- Author:
- No author available
- Journal Title:
- JOURNAL OF THE FOURTH MILITARY MEDICAL UNIVERSITY
- Issue:
- 24
- DOI:
- 10.3321/j.issn:1000-2790.2003.24.001
- Key Word:
- 生物等效性;临床试验;区间检验;生物统计;检验 效能
Abstract： 判定两组药物是否等效/非劣效/优效,传统的显著性检验方法是不妥的.区间假设检验对于保证受试药品(仿制药品)与参照药品等效/非劣效/优效,保证受试药品的有效性及安全性尤其重要.本文概要地介绍了区间假设检验的理论基础及一些相关的统计方面的问题,包括统计设计、检验方法、样本含量及检验效能的确定,特别介绍了有关个体等效与群体等效评价;总结了各种方法应该注意的事项并提出了一些目前区间假设检验依然存在的问题.无论是理论方面还是实际应用方面,这对于新药的审批具有一定的指导意义.
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