{"id":66707,"date":"2018-10-16T01:00:00","date_gmt":"2018-12-07T04:04:41","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/0a34edcf40\/"},"modified":"2018-12-07T12:04:44","modified_gmt":"2018-12-07T04:04:44","slug":"0a34edcf40","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/66707\/","title":{"rendered":"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724"},"content":{"rendered":"
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\"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/section>\n
\u66f4\u591a\u7cbe\u5f69\uff0c\u8bf7\u70b9\u51fb\u4e0a\u65b9\u84dd\u5b57\u5173\u6ce8\u6211\u4eec\uff01<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n

<\/span><\/strong>
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<\/span><\/strong><\/p>\n

\u4e00\u3001\u57fa\u672c\u6982\u5ff5<\/span><\/strong>  <\/span>\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>bioequivalency , BE <\/span><\/span>\uff09\u662f\u6307\u5728\u540c\u6837\u8bd5\u9a8c\u6761\u4ef6\u4e0b\u8bd5\u9a8c\u5236\u5242\u548c\u5bf9\u7167\u6807\u51c6\u5236\u5242\u5728\u836f\u7269\u7684\u5438\u6536\u7a0b\u5ea6\u548c\u901f\u5ea6\u7684\u7edf\u8ba1\u5b66\u5dee\u5f02\u3002\u751f\u7269\u7b49\u6548\u6027\u7528\u4e8e\u8bc4\u4ef7\u4e24\u4e2a\u836f\u7269\u5bf9\u67d0\u75be\u75c5\u60a3\u8005\u7684\u6548\u5e94<\/span>(<\/span>\u5b89\u5168\u6027\u548c\u6709\u6548\u6027<\/span>)<\/span>\u662f\u5426\u76f8\u540c\u6216\u76f8\u8fd1\u3002\u4f8b\u5982\u4eff\u5236\u836f\u4e0e\u6807\u51c6\u836f<\/span>,<\/span>\u5929\u7136\u836f\u4e0e\u5316\u5b66\u836f\uff0c\u53e3\u670d\u836f\u4e0e\u9488\u5242\uff0c\u957f\u6548\u836f\u4e0e\u77ed\u6548\u836f\uff0c\u67d0\u836f\u4f4e\u5242\u91cf\u4e0e\u9ad8\u5242\u91cf\u7684\u6bd4\u8f83\u9700\u8981\u7528\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u6765\u8bc4\u4ef7\u3002<\/span>FDA <\/span><\/span>\u89c4\u5b9a<\/span>, <\/span><\/span>\u82e5\u4eff\u5236\u836f\u54c1\u4e0e\u6ce8\u518c\u836f\u54c1\u95f4\u5177\u6709\u751f\u7269\u7b49\u6548\u6027<\/span>,<\/span>\u7533\u62a5\u8fc7\u7a0b\u53ef\u6309\u7f29\u7565\u7533\u62a5\u7a0b\u5e8f<\/span>( abbreviated new drug application, ANDA)<\/span>\u8fdb\u884c\uff0c\u800c\u4e0d\u9700\u8981\u6309\u65b0\u836f\u7533\u62a5\u7a0b\u5e8f<\/span>( new drug application, NDA)<\/span>\u8fdb\u884c<\/span>,<\/span>\u907f\u514d\u4e86\u8017\u65f6\u3001\u6602\u8d35\u7684\u2160\u3001\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u6240\u4ee5\uff0c\u751f\u7269\u7b49\u6548\u6027\u68c0\u9a8c\u5728\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5360\u6709\u6781\u5176\u91cd\u8981\u7684\u5730\u4f4d\u3002<\/span><\/span><\/p>\n


<\/span><\/p>\n

\u4e8c\u3001\u4e3b\u8981\u53c2\u6570<\/span><\/strong>\u5728\u836f\u52a8\u5b66\u53c2\u6570\u4e2d\uff0c\u8868\u5f81\u5438\u6536\u7a0b\u5ea6\u548c\u901f\u5ea6\u7684\u53c2\u6570\u4e3b\u8981\u662f<\/span>AUC<\/span>\u3001<\/span>Tmax<\/span>\u548c<\/span>Cmax<\/span>\u3002\u56e0\u6b64\uff0c\u7528\u836f\u52a8\u5b66\u65b9\u6cd5\u8bc4\u4ef7\u5236\u5242\u95f4\u662f\u5426\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\uff0c\u5c31\u662f\u4ee5\u7edf\u8ba1\u5b66\u65b9\u6cd5\u8bc4\u4ef7\u8bd5\u9a8c\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u6d4b\u5f97\u7684<\/span>AUC<\/span>\u3001<\/span>Tmax<\/span>\u548c<\/span>Cmax<\/span>\u7b49\u6307\u6807\u662f\u5426\u6ee1\u8db3\u9884\u5148\u8bbe\u5b9a\u7684\u7b49\u6548\u6807\u51c6\u3002\u9884\u5148\u8bbe\u5b9a\u7684\u7b49\u6548\u6807\u51c6\u5982\u4f55\uff0c\u4e5f\u5c31\u6210\u4e3a\u5f71\u54cd<\/span>BE<\/span>\u8bc4\u4ef7\u7684\u5173\u952e\u56e0\u7d20\u4e4b\u4e00\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u4e09\u3001\u8bd5\u9a8c\u8bbe\u8ba1\u7c7b\u578b<\/span><\/strong> <\/span>1.<\/span>\u4e24\u5236\u5242\u3001\u5355\u8bcd\u7ed9\u836f\u3001\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1\uff1b<\/span>2.<\/span>\u4e24\u5236\u5242\u3001\u5355\u8bcd\u7ed9\u836f\u3001\u5e73\u884c\u8bd5\u9a8c\u8bbe\u8ba1\uff1b<\/span>3.<\/span>\u91cd\u590d\u8bd5\u9a8c\u8bbe\u8ba1\u3002\u5bf9\u4e8e\u4e00\u822c\u836f\u7269\uff0c\u63a8\u8350\u9009\u7528\u7b2c\u4e00\u79cd\u8bd5\u9a8c\u8bbe\u8ba1\u7eb3\u5165\u5065\u5eb7\u7537\u6027\u5fd7\u613f\u8005\u53c2\u4e0e\u7814\u7a76\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u56db\u3001\u7edf\u8ba1\u5206\u6790\u8981\u6c42<\/span><\/strong><\/p>\n

\uff08\u4e00\uff09  <\/span><\/span>\u5bf9\u6570\u8f6c\u6362\u8bc4\u4ef7<\/span>BE<\/span>\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570<\/span>AUC<\/span>\u548c<\/span>Cmax<\/span>\u5728\u7b49\u6548\u6027\u68c0\u9a8c\u524d\u987b\u4f5c\u5bf9\u6570\u8f6c\u6362\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09  <\/span><\/span>\u7b49\u6548\u5224\u65ad\u6807\u51c6\u7b2c\u4e00\u6b65\uff1a\u5bf9\u4e3b\u8981\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u68c0\u9a8c\u666e\u904d\u91c7\u7528\u5bf9\u6570\u8f6c\u6362\u540e\u4ee5\u591a\u56e0\u7d20\u65b9\u5dee\u5206\u6790\u8fdb\u884c\u5047\u8bbe\u68c0\u9a8c\uff0c\u68c0\u9a8c\u4e24\u79cd\u836f\u7269\u662f\u5426\u6709\u5dee\u5f02\uff0c\u68c0\u9a8c\u65b9\u5f0f\u4e3a\u662f\u6216\u5426\uff0c\u5728<\/span>p<0.05<\/span>\u65f6\u8ba4\u4e3a\u4e24\u8005\u5dee\u5f02\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\uff0c\u4f46\u4e0d\u4e00\u5b9a\u4e0d\u7b49\u6548\uff1b<\/span>p>0.05<\/span>\u65f6\u8ba4\u4e3a\u4e24\u8005\u5dee\u5f02\u65e0\u7edf\u8ba1\u5b66\u610f\u4e49\uff0c\u4f46\u7edd\u4e0d\u8ba4\u4e3a\u4e24\u8005\u76f8\u7b49\u6216\u76f8\u8fd1\u3002\u4ea4\u53c9\u8bd5\u9a8c\u4e2d\uff0c\u591a\u56e0\u7d20\u65b9\u5dee\u5206\u6790\u5224\u65ad\u836f\u7269\u5236\u5242\u95f4\u3001\u4e2a\u4f53\u95f4\u3001\u5468\u671f\u95f4\u548c\u670d\u836f\u987a\u5e8f\u95f4\u7684\u5dee\u5f02\uff0c\u800c\u670d\u836f\u987a\u5e8f\u548c\u4e2a\u4f53\u95f4\u662f\u4e00\u79cd\u5d4c\u5957\u5173\u7cfb\uff0c\u5373\u4e2a\u4f53\u95f4\u5d4c\u5957\u5728\u670d\u836f\u987a\u5e8f\u5185\uff0c\u56e0\u6b64\u5728\u670d\u836f\u987a\u5e8f\u7684\u6548\u5e94\u56e0\u4ee5\u4e2a\u4f53\u95f4\u8bef\u5dee\u4e3a\u5206\u6bcd\u3002\u65b9\u5dee\u5206\u6790\u672c\u8eab\u4e0d\u80fd\u80dc\u4efb\u7b49\u6548\u5224\u65ad\uff0c\u4f46\u5176\u7ed3\u679c\u4e3a\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8fdb\u884c\u53cc\u5355\u4fa7<\/span>t<\/span>\u68c0\u9a8c\u63d0\u4f9b\u989d\u57fa\u7840\u3002\u7b2c\u4e8c\u6b65\uff1a\u53cc\u5355\u4fa7<\/span>t<\/span>\u68c0\u9a8c\u548c\u8ba1\u7b97<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u7684\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5\u6765\u8bc4\u4ef7\u548c\u5224\u65ad\u836f\u7269\u95f4\u7684\u751f\u7269\u7b49\u6548\u6027\u3002\u53cc\u5355\u4fa7<\/span>t<\/span>\u68c0\u9a8c\uff08<\/span>TOST<\/span>\uff09\u548c<\/span>100*<\/span>\uff08<\/span>1-2<\/span>\u03b1<\/span>\uff09<\/span>%<\/span>\u7f6e\u4fe1\u533a\u95f4\u662f\u76ee\u524d\u751f\u7269\u7b49\u6548\u68c0\u9a8c\u7684\u6700\u5e38\u7528\u4e14<\/span>\u516c\u8ba4\u7684\u65b9\u6cd5\u3002\u53cc\u5355\u4fa7<\/span>t\u68c0\u9a8c\u662f\u7b49\u6548\u6027\u68c0\u9a8c\uff0c\u96f6\u5047\u8bbe\u4e3a\u4e24\u836f\u4e0d\u7b49\u6548\uff0c\u53d7\u8bd5\u5236\u5242\u5728\u53c2\u6bd4\u5236\u5242\u4e00\u5b9a\u8303\u56f4\u4e4b\u5916\uff0c\u82e5\u53d6\u03b1=0.05\uff0c\u5219p<0.05\u65f6\u8bf4\u660e\u53d7\u8bd5\u5236\u5242\u6ca1\u6709\u8d85\u8fc7\u89c4\u5b9a\u7684\u53c2\u6bd4\u5236\u5242\u7684\u9ad8\u9650\u548c\u4f4e\u9650\uff0c\u62d2\u7edd\u96f6\u5047\u8bbe\uff0c\u53ef\u8ba4\u4e3a\u4e24\u836f\u7b49\u6548\u3002\u53cd\u4e4b\u4ea6\u7136\u3002\u540c\u65f6\u4e5f\u53ef\u4ee5\u4ece\u53c2\u6570\u4f30\u8ba1\u4e0a\u4f9d\u636e100\uff081-2\u03b1\uff09%\u7f6e\u4fe1\u533a\u95f4\u8fdb\u884c\u5224\u65ad\u3002\u6211\u56fd2016\u5e74\u53d1\u5e03\u7684\u300a\u4ee5\u836f\u52a8\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u5efa\u8bae\u4e3b\u8981\u836f\u52a8\u5b66\u53c2\u6570AUC\u548cCmax\u4e00\u822c\u60c5\u51b5\u4e0b\u51e0\u4f55\u5747\u503c\u6bd4\u503c90%\u7f6e\u4fe1\u533a\u95f4\u6570\u503c\u5e94\u4e0d\u4f4e\u4e8e80.00%\uff0c\u4e14\u4e0d\u8d85\u8fc7125.00%,\u4e14\u4e0d\u80fd\u901a\u8fc7\u56db\u820d\u4e94\u5165\u7684\u65b9\u6cd5\u8fbe\u5230\u8981\u6c42\u3002\u53cc\u5355\u4fa7\u68c0\u9a8c\u5047\u8bbe\u53ca\u7edf\u8ba1\u91cf\u516c\u5f0f\uff1a<\/span><\/p>\n

<\/span><\/p>\n

\"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n

`<\/span>xT<\/sub> ,<\/span>`<\/span>xR<\/sub> <\/span>\u5206\u522b\u4e3a\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684<\/span>PK<\/span>\u53c2\u6570\u7684\u5bf9\u6570\u5747\u503c\uff0c\u5728\u53cc\u4ea4\u53c9\u4e2d\u4e3a\u6700\u5c0f\u4e8c\u4e58\u6cd5\u5747\u6570\uff0c<\/span>r1,r2<\/span>\u5206\u522b\u4e3a\u7ba1\u7406\u90e8\u95e8\u5b9a\u51fa\u7684\u751f\u7269\u7b49\u6548\u6027\u7684\u4f4e\u9ad8\u4fa7\u754c\u9650\uff0c\u4e00\u822c\u4e3a<\/span>0.8<\/span>\u548c<\/span>1.25<\/span>\uff1b<\/span>S<\/span>\u4e3a\u539f\u6570\u636e\u81ea\u7136\u5bf9\u6570\u8f6c\u6362\u540e\u7ecf\u65b9\u5dee\u5206\u6790\u5f97\u51fa\u7684\u6837\u672c\u8bef\u5dee\u5747\u65b9\u7684\u5e73\u65b9\u6839\uff1b<\/span>n<\/span>\u4e3a\u8bd5\u9a8c\u4e2a\u6570\uff0c\u5373\u53ef\u7528\u4e8e\u5206\u6790\u751f\u7269\u7b49\u6548\u6027\u7684\u53d7\u8bd5\u8005\u4eba\u6570\uff1b<\/span>`<\/span>xT<\/sub> ,<\/span>`<\/span>xR<\/sub><\/span>\u548c<\/span>S<\/span>\u5747\u901a\u8fc7\u65b9\u5dee\u5206\u6790\u5f97\u5230\u3002<\/span><\/p><\/pre>\n
100<\/span>\uff08<\/span>1-<\/span>2\u03b1<\/span>\uff09\u7f6e\u4fe1\u533a\u95f4\u8ba1\u7b97\u516c\u5f0f<\/span>`<\/span>\u3002

<\/span><\/p><\/pre>\n
\u4e94\u3001SAS<\/span>\u5b9e\u73b0\u4ee5\u53cc\u4ea4\u53c9\u8bd5\u9a8c\u8bbe\u8ba1<\/span>AUC<\/span>\u6d4b\u5b9a\u503c\u4e3a\u4f8b\u3002<\/span><\/strong><\/p>\n
\uff08\u4e00\uff09  <\/span>\u65b9\u5dee\u5206\u6790<\/span><\/span><\/p>\n
I <\/span><\/span>\u901a\u5e38\u53ef\u4ee5<\/span>proc glm<\/span>\u548c<\/span>proc mixed<\/span>\u4e24\u4e2a\u6a21\u578b\u5b9e\u73b0\u3002\u7a0b\u5e8f\u5982\u4e0b\uff1a<\/span><\/p>\n
*<\/span>\u8bd5\u9a8c\u6570\u636e\uff0c<\/span>subjid<\/span>\u53d7\u8bd5\u8005<\/span>ID,seq<\/span>\u8bd5\u9a8c\u987a\u5e8f\uff0c<\/span>period<\/span>\u8bd5\u9a8c\u5468\u671f\uff0c<\/span>drug<\/span>\uff1a\u5904\u7406\u56e0\u7d20\uff08\u836f\u7269\uff09<\/span>;<\/span><\/p>\n
data<\/span><\/strong> <\/span>test;<\/span><\/p>\n
input<\/span> <\/span>subjid <\/span><\/span>$3. <\/span>seq <\/span><\/span>$4.<\/span> <\/span>period drug <\/span><\/span>$1.<\/span> <\/span>auc;<\/span><\/p>\n
*<\/span>\u5bf9<\/span>PK<\/span>\u53c2\u6570\u53d6\u5bf9\u6570\u518d\u8fdb\u884c\u5206\u6790<\/span>;<\/span><\/p>\n
log=log(auc);<\/span><\/p>\n
cards<\/span>;<\/span><\/p>\n
1  R-T 1 R 838<\/span><\/p>\n
2  R-T 1 R 749<\/span><\/p>\n
3  R-T 1 R 953<\/span><\/p>\n
4  R-T 1 R 637<\/span><\/p>\n
5  R-T 1 R 867<\/span><\/p>\n
6  R-T 1 R 960<\/span><\/p>\n
7  R-T 1 R 455<\/span><\/p>\n
8  R-T 1 R 819<\/span><\/p>\n
9  R-T 1 R 400<\/span><\/p>\n
10  R-T 1 R 800<\/span><\/p>\n
1  R-T 2 T 1225<\/span><\/p>\n
2  R-T 2 T 757<\/span><\/p>\n
3  R-T 2 T 826<\/span><\/p>\n
4  R-T 2 T 532<\/span><\/p>\n
5  R-T 2 T 793<\/span><\/p>\n
6  R-T 2 T 1027<\/span><\/p>\n
7  R-T 2 T 1112<\/span><\/p>\n
8  R-T 2 T 840<\/span><\/p>\n
9  R-T 2 T 1000<\/span><\/p>\n
10 R-T 2 T800<\/span><\/p>\n
11 T-R 1 T783<\/span><\/p>\n
12 T-R 1 T960<\/span><\/p>\n
13 T-R 1 T947<\/span><\/p>\n
14 T-R 1 T780<\/span><\/p>\n
15 T-R 1 T932<\/span><\/p>\n
16 T-R 1 T 929<\/span><\/p>\n
17 T-R 1 T889<\/span><\/p>\n
18 T-R 1 T846<\/span><\/p>\n
19 T-R 1 T695<\/span><\/p>\n
20 T-R 1 T746<\/span><\/p>\n
11 T-R 2 R560<\/span><\/p>\n
12 T-R 2 R734<\/span><\/p>\n
13 T-R 2 R1227<\/span><\/p>\n
14 T-R 2 R198<\/span><\/p>\n
15 T-R 2 R1071<\/span><\/p>\n
16 T-R 2 R900<\/span><\/p>\n
17 T-R 2 R772<\/span><\/p>\n
18 T-R 2 R897<\/span><\/p>\n
19 T-R 2 R707<\/span><\/p>\n
20 T-R 2 R1293<\/span><\/p>\n
;<\/span><\/p>\n
run<\/span><\/strong>;<\/span><\/p>\n
*<\/span>\u591a\u56e0\u7d20\u65b9\u5dee\u5206\u6790<\/span>;<\/span><\/p>\n
*Method 1<\/span><\/strong>\uff1a<\/span><\/strong>glm;<\/span><\/strong><\/p>\n
proc <\/span><\/strong>glm <\/span><\/strong>data<\/span>=test;<\/span><\/p>\n
class<\/span> <\/span>seq subjid drug period;<\/span><\/p>\n
*subjid(seq)<\/span>\u6307\u5b9a<\/span>subjid<\/span>\u5d4c\u5957\u5728<\/span>seq<\/span>\u5185<\/span>;<\/span><\/p>\n
model<\/span> <\/span>log=seq subjid(seq) period drug;<\/span><\/p>\n
*random<\/span>\u6307\u5b9a<\/span>subjid(seq)<\/span>\u4e3a\u968f\u673a\u6548\u5e94\uff0c<\/span>test<\/span>\u5bf9\u968f\u673a\u6548\u5e94\u8fdb\u884c\u68c0\u9a8c<\/span>,<\/span>\u5373\u6307\u5b9a<\/span>subjid(seq)<\/span>\u4e3a<\/span>seq<\/span>\u7684\u8bef\u5dee\u9879\uff0c\u5728\u8ba1\u7b97\u8bef\u5dee\u9879\u65f6\u4e0d\u9700\u8981\u8be5\u8bed\u53e5<\/span>;<\/span><\/p>\n
random<\/span> <\/span>subjid(seq)\/<\/span>test<\/span>;<\/span><\/p>\n
*<\/span>\u6c42\u51e0\u4f55\u5e73\u5747\u503c\u6bd4<\/span>;<\/span><\/p>\n
estimate <\/span>“T VS. R”<\/span>  drug  <\/span>1<\/span><\/strong> <\/span>–<\/span>1<\/span><\/strong>;<\/span><\/p>\n
*test<\/span>\u6307\u5b9a<\/span>seq<\/span>\u7684\u8bef\u5dee\u9879\u4e3a<\/span>subjid(seq);<\/span><\/p>\n
testh<\/span>=seq <\/span>e<\/span>=subjid(seq);<\/span><\/p>\n
*<\/span>\u6c42\u6700\u5c0f\u4e8c\u4e58\u6cd5\u5747\u503c<\/span>;<\/span><\/p>\n
lsmeans<\/span> <\/span>drug;<\/span><\/p>\n
run<\/span><\/strong>;<\/span><\/p>\n
*Method 2:mixed;<\/span><\/strong><\/p>\n
proc <\/span><\/strong>mixed <\/span><\/strong>data<\/span>=test;<\/span><\/p>\n
class<\/span> <\/span>seq subjid period drug;<\/span><\/p>\n
*ddfm=<\/span>\u6307\u5b9a\u5206\u6bcd\u81ea\u7531\u5ea6\u8ba1\u7b97\u65b9\u6cd5<\/span>;<\/span><\/p>\n
model<\/span> <\/span>log = seq period drug\/<\/span>htype<\/span>=<\/span>1<\/span><\/strong>  <\/span><\/span>ddfm<\/span>=satterth;<\/span><\/p>\n
*<\/span>\u6307\u5b9a\u622a\u8ddd\u4f5c\u4e3a\u968f\u673a\u6548\u5e94\uff0c<\/span>subject=<\/span>\u6307\u5b9a<\/span>subject,<\/span>\u53cc\u4ea4\u53c9<\/span>subject<\/span>\u5d4c\u5957\u5728\u8bd5\u9a8c\u5e8f\u5217\u4e2d<\/span>;<\/span><\/p>\n
random<\/span> <\/span>intercept \/ <\/span><\/span>subject<\/span>=subjid(seq);<\/span><\/p>\n
*<\/span>\u8ba1\u7b97\u51e0\u4f55\u5e73\u5747\u503c\u6bd4\u548c<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4<\/span>;<\/span><\/p>\n
estimate<\/span>“T VS. R”<\/span> <\/span>drug <\/span><\/span>1<\/span><\/strong> <\/span>–<\/span>1<\/span><\/strong> <\/span>\/<\/span>clalpha<\/span>=<\/span>0.1<\/span><\/strong>;<\/span><\/p>\n
*<\/span>\u6c42\u6700\u5c0f\u4e8c\u4e58\u6cd5\u5747\u503c<\/span>;<\/span><\/p>\n
lsmeans<\/span> <\/span>drug;<\/span><\/p>\n
run<\/span><\/strong>;<\/span><\/p>\n
<\/span><\/p>\n
II \u4e24\u79cd\u65b9\u6cd5\u5173\u952e\u70b9\u7684\u6bd4\u8f83\uff1a<\/span><\/p>\n
    \n
  1. \n
    \u53d7\u8bd5\u8005\u56e0\u7d20<\/span><\/strong>GLM\u6a21\u578b\u9700\u8981\u5728model\u8bed\u53e5\u91cc\u6307\u5b9asubjid(seq)\uff0c\u56e0\u4e3atest\u8bed\u53e5\u6307\u5b9asubjid(seq)\u4e3aseq\u7684\u8bef\u5dee\u9879\uff0ctest\u8bed\u53e5\u4e2d\u7684effects\u9700\u8981\u5728model\u8bed\u53e5\u91cc\u51fa\u73b0\u3002MIXED\u6a21\u578b\u4e0d\u9700\u8981\u5199\u5165subjid(seq)\uff0c\u5982\u679c\u9700\u8981\u68c0\u9a8csubjid(seq)\uff0c\u9700\u8981\u5c06random\u8bed\u53e5\u5f15\u53bb\uff0c\u5728model\u8bed\u53e5\u91cc\u52a0\u5165subjid(seq)\u56e0\u7d20\u3002<\/span><\/p>\n<\/li>\n
  2. \n
    \u51e0\u4f55\u5747\u503c\u6bd4\u7684<\/span>90%<\/span><\/strong>\u533a\u95f4<\/span><\/strong> <\/span>GLM<\/span>\u4e0d\u80fd\u8f93\u51fa\u51e0\u4f55\u5747\u503c\u6bd4\u7684<\/span>90%<\/span>\u533a\u95f4\uff0c\u8fd9\u4e2a\u9700\u8981\u901a\u8fc7\u6a21\u578b\u8ba1\u7b97\u51fa\u8bef\u5dee\u9879\u5747\u65b9\u7684\u5e73\u65b9\u6839\uff08<\/span>S<\/span>\uff09\uff0c\u901a\u8fc7\u516c\u5f0f\u8ba1\u7b97\u51fa\u4e24\u4e2a\u9650\u503c\u3002<\/span>MIXED<\/span>\u6a21\u578b\u53ef\u4ee5\u901a\u8fc7\u8bbe\u7f6e<\/span>clalpha<\/span>\u4e24\u4e2a\u9009\u9879\u8f93\u51fa\u9650\u503c\u3002<\/span><\/p>\n<\/li>\n
  3. \n
    \u5904\u7406\u987a\u5e8f\u56e0\u7d20\u7684\u68c0\u9a8c<\/span><\/strong>\u5728<\/span>glm<\/span>\u6a21\u578b\u4e2d<\/span>model<\/span>\u8bed\u53e5\u91cc\u7528<\/span>random<\/span>\u6307\u5b9a<\/span>seq<\/span>\u7684\u8bef\u5dee\u9879\u5373\u53ef\uff1b\u5728<\/span>mixed<\/span>\u6a21\u578b\u76f8\u5bf9\u590d\u6742\u70b9\uff0c\u4e2d\u4e5f\u9700\u8981<\/span>random<\/span>\u6307\u5b9a<\/span>seq<\/span>\u7684\u8bef\u5dee\u9879\u540e\u53ef\u5f97\u3002<\/span><\/p>\n<\/li>\n
  4. \n
    \u6837\u672c\u8bef\u5dee\u503c<\/span> <\/span>mixed<\/span><\/strong>\u6a21\u578b\u9700\u5c06<\/span>random<\/span><\/strong>\u8bed\u53e5\u5f15\u53bb\u540e\u6a21\u578b\u6c42\u7684\u503c<\/span><\/strong><\/p>\n<\/li>\n<\/ol>\n
    III<\/span>\u6a21\u578b\u5173\u952e\u7ed3\u679c\u89e3\u8bfb\uff1a<\/span><\/p>\n
    <\/span><\/p>\n
    1\u3001\u6837\u672c\u8bef\u5dee\u503c<\/span><\/p>\n
    <\/span><\/p>\n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n
    2\u3001<\/span>\u56db\u4e2a\u56e0\u7d20\u7684\u68c0\u9a8c<\/span><\/p>\n
    MIXED\u6a21\u578b\u5728\u68c0\u9a8c\u5904\u7406\u56e0\u7d20\u65f6\uff0crandom\u6307\u5b9asubjid(seq)\uff0c\u6c42\u53d7\u8bd5\u8005\u56e0\u7d20\u5047\u8bbe\u68c0\u9a8c\u7ed3\u679c\u65f6\u9700\u5f15\u53bbrandom\u8bed\u53e5\u3002<\/span><\/p>\n
    <\/span><\/p>\n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n
    <\/span>3\u3001\u6700\u5c0f\u4e8c\u4e58\u6cd5\u5747\u503c Lsmeans\u8bed\u53e5\u6307\u5b9a\u5904\u7406\u56e0\u7d20\u3002<\/span><\/p>\n
    <\/span><\/p>\n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n
    <\/span>4\u3001\u51e0\u4f55\u5747\u503c\u6bd4\u548c<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u3002<\/span>Glm<\/span>\u6a21\u578b\u7684\u7f6e\u4fe1\u533a\u95f4\u9700\u8981\u901a\u8fc7\u516c\u5f0f\u8ba1\u7b97\uff0c\u5982\u4e0b\uff0c<\/span>r1,r2<\/span>\u4e3a\u7b49\u6548\u6807\u51c6\uff0c<\/span>r1<\/span>\u4e00\u822c\u53d6<\/span>0.8,r2<\/span>\u53d6<\/span>1.25<\/span>\u3002<\/span>S<\/span>\u539f\u6570\u636e\u8f6c\u6362\u540e\u7ecf\u65b9\u5dee\u5206\u6790\u5f97\u51fa\u7684\u6837\u672c\u8bef\u5dee\u5747\u65b9\u7684\u5e73\u65b9\u6839\u3002<\/span><\/p>\n
    LT<\/sub><\/span>\u548c<\/span>LR<\/sub><\/span>\u5206\u522b\u4e3a\u539f\u59cb\u6570\u636e\u8f6c\u6362\u540e\u7684\u7b97\u672f\u5747\u6570\u3002<\/span>Mixed<\/span>\u6a21\u578b\u53ef\u4ee5\u76f4\u63a5\u5f97\u51fa\u76f8\u5e94\u7684\u7ed3\u679c\u3002<\/span><\/span><\/p>\n
    <\/span><\/p>\n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n
    \u51e0\u4f55\u5747\u503c\uff0c\u6807\u51c6\u5dee\uff0c\u51e0\u4f55\u5747\u503c\u6bd4\u5747\u9700\u8981<\/span>EXP<\/span>\u8f6c\u56de\u53bb\u3002<\/span><\/p>\n
    \uff08\u4e8c\uff09  <\/span>\u53cc\u5355\u4fa7\u68c0\u9a8c<\/span><\/p>\n
    \u7b2c\u4e00\u6b65\uff1a\u6839\u636e\u65b9\u5dee\u5206\u6790\u8f93\u51fa<\/span>`<\/span>xT<\/sub> <\/span>,<\/span>`<\/span>xR <\/span><\/sub>,S<\/span>\uff0c\u7528\u4e8e\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u5bf9\u8c61\u6570<\/span>n<\/span>\u7684\u7ed3\u679c\uff0c<\/span>r1<\/span>\u7b49\u4e8e<\/span>0.8,r2<\/span>\u7b49\u4e8e<\/span>1.25<\/span>\uff0c<\/span>S<\/span>\u4e3a\u6837\u672c\u8bef\u5dee\u503c\u7684\u5e73\u65b9\u6839\uff0c\u5c06\u8fd9\u51e0\u4e2a\u503c\u5e26\u5165\u516c\u5f0f\u8ba1\u7b97\u68c0\u9a8c\u7edf\u8ba1\u91cf<\/span>T1<\/span>\u548c<\/span>T2<\/span>\uff1b<\/span><\/p>\n
    <\/span><\/p>\n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"<\/p>\n
    \u7b2c\u4e8c\u6b65\uff1a\u6c42p\u503c  \u8fd9\u91cc\u8bef\u5dee\u7684\u81ea\u7531\u5ea6\u6839\u636e\u65b9\u5dee\u5206\u6790\u8f93\u51fa\uff0c\u6216\u8005n=n-2\uff0cp\u503c\u8ba1\u7b97\u516c\u5f0fp=(1-probt(ABS(t_value),n))\u3002<\/span><\/p>\n

    <\/span><\/p>\n
    <\/span><\/p>\n
     <\/span>\u6ce8\u610f\uff1a\u65b9\u5dee\u5206\u6790\u9700\u8981\u8f93\u51fa\u4e00\u4e9b\u7ed3\u679c\u53ef\u4ee5\u901a\u8fc7<\/span>ods output<\/span>\u5230\u6307\u5b9a\u7684\u6570\u636e\u96c6\u4e2d\uff0c\u7136\u540e\u8c03\u7528\u3002<\/span><\/p>\n
    Tmax<\/sub><\/span>\u548c<\/span>T1\/2<\/sub><\/span>\u7684\u65b9\u5dee\u5206\u6790\u53ef\u53c2\u89c1\u6587\u732e\u300a<\/span>Hodges-Lehmann confidence intervals for ashift in location using SAS\u00ae procedure SQL<\/span>\u300b\u3002<\/span><\/p>\n

    <\/p>\n
    \u3010\u8f6c\u81ea\uff1asas\u5e94\u7528\u5206\u6790\u3011<\/strong><\/span><\/p>\n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \"\u4e34\u5e8a\u8bd5\u9a8c\u751f\u7269\u7b49\u6548\u6027\u7edf\u8ba1\u5206\u6790-SAS\u5b9e\u73b0\u65b9\u6cd5\u603b\u7ed3\u2014\u2014\u57f9\u4f18BE\u7cfb\u521724\"
    <\/p>\n<\/section>\n<\/section>\n<\/section>\n
    \n
    \n
    \n
    <\/section>\n<\/section>\n<\/section>\n<\/section>\n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \n
    \u514d\u8d23\u58f0\u660e\uff1a<\/span><\/p>\n
    \u672c\u6587\u4fe1\u606f\u90e8\u5206\u5185\u5bb9\u6765\u81ea\u7f51\u7edc\u6587\u7ae0\uff0c\u4e0d\u4fdd\u8bc1\u6240\u6709\u4fe1\u606f\u3001\u6587\u672c\u3001\u56fe\u5f62\u3001\u94fe\u63a5\u53ca\u5176\u4ed6\u9879\u76ee\u7684\u7edd\u5bf9\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\uff0c\u6545\u4ec5\u4f9b\u8bbf\u95ee\u8005\u53c2\u7167\u9002\u7528\u3002\u5982\u60a8\uff08\u5355\u4f4d\u6216\u4e2a\u4eba\uff09\u8ba4\u4e3a\u672c\u6587\u67d0\u90e8\u5206\u5185\u5bb9\u6709\u4fb5\u6743\u5acc\u7591\uff0c\u656c\u8bf7\u7acb\u5373\u901a\u77e5\u6211\u4eec\uff0c\u6211\u4eec\u5c06\u5728\u7b2c\u4e00\u65f6\u95f4\u4e88\u4ee5\u66f4\u6b63\u6216\u5220\u9664\u3002\u4ee5\u4e0a\u58f0\u660e\u4e4b\u89e3\u91ca\u6743\u5f52\u672c\u516c\u4f17\u53f7\u6240\u6709\u3002\u6cd5\u5f8b\u4e0a\u6709\u76f8\u5173\u89e3\u91ca\u7684\uff0c\u4ee5\u4e2d\u56fd\u6cd5\u5f8b\u4e4b\u89e3\u91ca\u4e3a\u57fa\u51c6\u3002\u5982\u6709\u4e89\u8bae\u9650\u5728\u6211\u65b9\u6240\u5728\u5730\u53f8\u6cd5\u90e8\u95e8\u89e3\u51b3\u3002\u8c22\u8c22\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

    <\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"
    \u66f4\u591a\u7cbe\u5f69\uff0c\u8bf7\u70b9\u51fb\u4e0a\u65b9\u84dd\u5b57\u5173\u6ce8\u6211\u4eec\uff01 \u4e00\u3001\u57fa\u672c\u6982\u5ff5  \u751f\u7269\u7b49\u6548\u6027\uff08bioequivalenc […]<\/p>\n","protected":false},"author":1,"featured_media":66708,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66707"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=66707"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66707\/revisions"}],"predecessor-version":[{"id":66720,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66707\/revisions\/66720"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/66708"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=66707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=66707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=66707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}