等效检验与非劣效检验（课堂PPT）

1、1等效检验与非劣效检验等效检验与非劣效检验2主要内容主要内容3一、两样本率的等效检验一、两样本率的等效检验 (equivalence test)4506方法方法71. u检验检验8 10121112:HH20122112:HH91012121()ppppu =S12122()ppppu =S1112112212(1)(1)ppppppSnn12132. 可信区间法LUC ,C（）LU- C C 141516 101211120.:10.10.025HH单侧201221120.1:0.10.025HH单侧1712112212(1)(1)0.9000(1 0.9000)0.8647(1 0.864

2、7)2002070.0319ppppppnSn本例本例 国产组 p1=0.9000，n1=200 进口组 p2=0.8647，n2=2071812121()(0.90000.8647)0.14.24140.0319ppppu =S12122()(0.90000.8647)0.12.02820.0319pppp=Su 1912)0.0250.025PtP (，查可得，界值表，2012120.05/2()(0.90000.8674) 1.96 0.0319(-0.027 0.098)pppuSp，效果等价21注意事项注意事项2223242/21122212() (1)(1) 2()uuN25二、两

3、均数的等效检验二、两均数的等效检验 26 10121112:/2HH单侧20122112:/2:HH单侧1. 假设检验法假设检验法2712122()XXXXt =S12121()XXXXt =S28122211221212(1)(1) 11()2XXSnSnSnnnn29302. 可信区间法LUCC（ , ）LU-d C C d3132表表3.5 3.5 厄贝沙坦与氯沙坦的厄贝沙坦与氯沙坦的4 4周降压效果周降压效果(kPa)(kPa)33 101211120.670.670.025:HH单侧201221120.67:0.670.025HH单侧3412221122121222(1)(1) 11

4、()21.89 (119 1) 1.40 (120 1)11()119 12021191200.215XXSnSnSnnnn 3512121()(1.912.21)0.671.720.215XXXXt =S12122()(1.912.21)0.674.510.215XXXXt =S 237212011923721201193612)0.0250.025PtP (，查可得，界值表，371212/2()(1.912.21) 1.96 0.215-0.721 0.121XXXXtS，（，）38注意事项注意事项3922221222/22212222/22211)()()()()()(1uuSkSNuu

5、SkSkN402222/21)()(2SuuNN411222/2122122222()()2 (1.645 1.645)8154(12 15)uuNN例42三、非劣效性检验三、非劣效性检验0431. 统计推断方法统计推断方法44假设检验法假设检验法0121121:HH ）12()2）dppu=S45可信区间法可信区间法120.05LppCduS464748012112:0.1436:0.1436HH 05. 0492）计算检验统计量）计算检验统计量1212()(0.89290.9571)0.14362.5440.0312ppppu=S120.8929(1-0.8929)0.9571(1-0.9571)0.0312140140pp=S50)0.05tP (，查 界值表可得51二、可信区间法二、可信区间法12120.05()(0.89290.9571) 1.64