{"id":10930,"date":"2018-06-13T01:00:00","date_gmt":"2018-07-27T09:51:23","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/cde%ef%bc%9a%e3%80%8a%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e7%a0%94%e7%a9%b6%e7%9a%84%e7%bb%9f%e8%ae%a1%e5%ad%a6%e6%8c%87%e5%af%bc%e5%8e%9f%e5%88%99%ef%bc%88%e5%be%81%e6%b1%82%e6%84%8f\/"},"modified":"2018-07-27T17:51:23","modified_gmt":"2018-07-27T09:51:23","slug":"cde%ef%bc%9a%e3%80%8a%e7%94%9f%e7%89%a9%e7%ad%89%e6%95%88%e6%80%a7%e7%a0%94%e7%a9%b6%e7%9a%84%e7%bb%9f%e8%ae%a1%e5%ad%a6%e6%8c%87%e5%af%bc%e5%8e%9f%e5%88%99%ef%bc%88%e5%be%81%e6%b1%82%e6%84%8f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/10930\/","title":{"rendered":"CDE\uff1a\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u548c\u300a\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u3002"},"content":{"rendered":"
\n

\"CDE\uff1a\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u548c\u300a\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u3002\"<\/p>\n

\"CDE\uff1a\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u548c\u300a\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u3002\"<\/p>\n


<\/p>\n

\u9644\u4ef61\uff1a  <\/strong><\/span>      <\/strong><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219<\/span><\/strong> <\/strong> <\/strong><\/p>\n

(<\/strong>\u5f81\u6c42\u610f\u89c1\u7a3f<\/span><\/strong>)<\/strong> <\/strong><\/p>\n

\u4e8c\u3007\u4e00\u516b\u5e74\u516d\u6708<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n

\u4e00\u3001  <\/span>\u6982\u8ff0<\/span><\/h1>\n

\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>Bioequivalence, BE<\/span>\uff09\u7814\u7a76\u662f\u6bd4\u8f83\u53d7\u8bd5\u5236\u5242\uff08<\/span>T<\/span>\uff09\u4e0e\u53c2\u6bd4\u5236\u5242\uff08<\/span>R<\/span>\uff09\u7684\u5438\u6536\u901f\u5ea6\u548c\u5438\u6536\u7a0b\u5ea6\u5dee\u5f02\u662f\u5426\u5728\u53ef\u63a5\u53d7\u8303\u56f4\u5185\u7684\u7814\u7a76\uff0c\u53ef\u7528\u4e8e\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u7684\u4e0a\u5e02\u7533\u8bf7\uff0c\u4e5f\u53ef\u7528\u4e8e\u5df2\u4e0a\u5e02\u836f\u7269\u7684\u53d8\u66f4\uff08\u5982\u65b0\u589e\u89c4\u683c\u3001\u65b0\u589e\u5242\u578b\u3001\u65b0\u7684\u7ed9\u836f\u9014\u5f84\uff09\u7533\u8bf7\u3002<\/span><\/span><\/p>\n

\u76ee\u524d\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u901a\u5e38\u63a8\u8350\u4f7f\u7528\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>Average Bioequivalence, ABE<\/span>\uff09\u65b9\u6cd5\u3002\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u53ea\u6bd4\u8f83\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u5e73\u5747\u6c34\u5e73\uff0c\u672a\u8003\u8651\u4e2a\u4f53\u5185\u53d8\u5f02\u53ca\u4e2a\u4f53\u4e0e\u5236\u5242\u7684\u4ea4\u4e92\u4f5c\u7528\u5f15\u8d77\u7684\u53d8\u5f02\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u53ef\u80fd\u9700\u8981\u8003\u8651\u5176\u4ed6\u5206\u6790\u65b9\u6cd5\u3002\u4f8b\u5982\u6c14\u96fe\u5242\u7684\u4f53\u5916<\/span>BE<\/span>\u7814\u7a76\u53ef\u91c7\u7528\u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>Population Bioequivalence<\/span>\uff0c<\/span>PBE<\/span>\uff09\u65b9\u6cd5\uff0c\u4ee5\u8bc4\u4ef7\u5236\u5242\u95f4\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u5e73\u5747\u6c34\u5e73\u53ca\u4e2a\u4f53\u5185\u53d8\u5f02\u662f\u5426\u7b49\u6548\u3002<\/span><\/span><\/p>\n

\u672c\u6307\u5bfc\u539f\u5219\u65e8\u5728\u4e3a\u4ee5\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7814\u7a76\u8bbe\u8ba1\u3001\u6570\u636e\u5206\u6790\u548c\u7ed3\u679c\u62a5\u544a\u63d0\u4f9b\u6280\u672f\u6307\u5bfc\uff0c\u662f\u5bf9\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6570\u636e\u8d44\u6599\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\u7684\u4e00\u822c\u539f\u5219\u3002\u5728\u5f00\u5c55\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u65f6\uff0c\u9664\u53c2\u8003\u672c\u6307\u5bfc\u539f\u5219\u7684\u5185\u5bb9\u5916\uff0c\u5c1a\u5e94\u7efc\u5408\u53c2\u8003\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\u548c\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u7b49\u76f8\u5173<\/span>\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n

\u4e8c\u3001  <\/span>\u7814\u7a76\u8bbe\u8ba1<\/span><\/h1>\n

\uff08\u4e00\uff09\u603b\u4f53\u8bbe\u8ba1\u8003\u8651<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u53ef\u91c7\u7528\u4ea4\u53c9\u8bbe\u8ba1\u6216\u8005\u5e73\u884c\u7ec4\u8bbe\u8ba1\u3002<\/span><\/p>\n

1.<\/span>\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e00\u822c\u5efa\u8bae\u91c7\u7528\u4ea4\u53c9\u8bbe\u8ba1\u7684\u65b9\u6cd5\u3002\u4ea4\u53c9\u8bbe\u8ba1\u7684\u4f18\u52bf\u5305\u62ec\uff1a\u53ef\u4ee5\u6709\u6548\u51cf\u5c11\u4e2a\u4f53\u95f4\u53d8\u5f02\u7ed9\u8bd5\u9a8c\u8bc4\u4ef7\u5e26\u6765\u7684\u504f\u501a\uff1b\u5728\u6837\u672c\u91cf\u76f8\u7b49\u7684\u60c5\u51b5\u4e0b\uff0c\u4f7f\u7528\u4ea4\u53c9\u8bbe\u8ba1\u6bd4\u5e73\u884c\u7ec4\u8bbe\u8ba1\u5177\u6709\u66f4\u9ad8\u7684\u68c0\u9a8c\u6548\u80fd\u3002<\/span><\/p>\n

\u4e24\u5236\u5242\u3001\u4e24\u5468\u671f\u3001\u4e24\u5e8f\u5217\u4ea4\u53c9\u8bbe\u8ba1\u662f\u4e00\u79cd\u5e38\u89c1\u7684\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u89c1\u8868<\/span>1<\/span>\u3002<\/span><\/span><\/p>\n

\u8868<\/span>1<\/span>\u4e24\u5236\u5242\u3001\u4e24\u5468\u671f\u3001\u4e24\u5e8f\u5217\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n


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

\u5e8f\u5217<\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

2<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

R<\/span><\/p>\n<\/td>\n

\n

T<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/span>\u5982\u679c\u9700\u8981\u51c6\u786e\u4f30\u8ba1\u67d0\u4e00\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u53ef\u91c7\u7528\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u3002\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u5305\u62ec\u90e8\u5206\u91cd\u590d\uff08\u5982\u4e24\u5236\u5242\u3001\u4e09\u5468\u671f\u3001\u4e09\u5e8f\u5217\uff09\u6216\u8005\u5b8c\u5168\u91cd\u590d\uff08\u5982\u4e24\u5236\u5242\u3001\u56db\u5468\u671f\u3001\u4e24\u5e8f\u5217\uff09\uff0c\u89c1\u8868<\/span>2<\/span>\u548c\u8868<\/span>3<\/span>\u3002<\/span><\/span><\/p>\n

\u8868<\/span>2<\/span>\u4e24\u5236\u5242\u3001\u4e09\u5468\u671f\u3001\u4e09\u5e8f\u5217\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/strong><\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

       1<\/span><\/p>\n<\/td>\n

\n

       2<\/span><\/p>\n<\/td>\n

\n

      3<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

1<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

3<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

T<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u8868<\/span>3<\/span>\u4e24\u5236\u5242\u3001\u56db\u5468\u671f\u3001\u4e24\u5e8f\u5217\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/strong><\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

       1<\/span><\/p>\n<\/td>\n

\n

      2<\/span><\/p>\n<\/td>\n

\n

       3<\/span><\/p>\n<\/td>\n

\n

      4<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n<\/thead>\n
\n

1<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

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

\n

T<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

2.<\/span>\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5728\u67d0\u4e9b\u7279\u5b9a\u60c5\u51b5\u4e0b\uff08\u4f8b\u5982\u534a\u8870\u671f\u8f83\u957f\u7684\u836f\u7269\uff09\uff0c\u4e5f\u53ef\u4ee5\u4f7f\u7528\u5e73\u884c\u7ec4\u8bbe\u8ba1\u3002\u5e73\u884c\u7ec4\u8bbe\u8ba1\u56e0\u4e2a\u4f53\u95f4\u53d8\u5f02\u7ed9\u8bd5\u9a8c\u5e26\u6765\u7684\u5f71\u54cd\u8f83\u4ea4\u53c9\u8bbe\u8ba1\u5927\uff0c\u5e94\u6709\u66f4\u4e25\u683c\u7684\u53d7\u8bd5\u8005\u5165\u9009\u6761\u4ef6\uff0c\u5982\u5e74\u9f84\u3001\u6027\u522b\u3001\u4f53\u91cd\u3001\u75be\u75c5\u53f2\u7b49\uff0c\u4e14\u9700\u4f7f\u7528\u5408\u7406\u7684\u968f\u673a\u5316\u65b9\u6848\u786e\u4fdd\u7ec4\u95f4\u7684\u57fa\u7ebf\u6c34\u5e73\u5747\u8861\u4ee5\u5f97\u5230\u66f4\u597d\u7684\u7ec4\u95f4\u53ef\u6bd4\u6027\u3002<\/span><\/p>\n

3.<\/span>\u5176\u4ed6\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5982\u679c\u91c7\u7528\u9002\u5e94\u6027\u8bbe\u8ba1\u7b49\u5176\u4ed6\u8bbe\u8ba1\u65b9\u6cd5\uff0c\u53ef\u53c2\u8003\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\uff0c\u4e14\u5e94\u4e8b\u5148\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u6837\u672c\u91cf<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u8bd5\u9a8c\u524d\u9700\u5145\u5206\u4f30\u8ba1\u6240\u9700\u7684\u6837\u672c\u91cf\uff0c\u4ee5\u4fdd\u8bc1\u8db3\u591f\u7684\u68c0\u9a8c\u6548\u80fd\uff0c\u5e76\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u8be6\u7ec6\u8bf4\u660e\u6837\u672c\u91cf\u4f30\u8ba1\u65b9\u6cd5\u548c\u7ed3\u679c\u3002\u4f7f\u7528<\/span>ABE<\/span>\u65b9\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u65f6\uff0c\u5e94\u57fa\u4e8e\u660e\u786e\u7684\u516c\u5f0f\u5408\u7406\u4f30\u8ba1\u6837\u672c\u91cf\u3002\u4e0d\u540c\u7684\u8bbe\u8ba1\uff0c\u5bf9\u5e94\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u516c\u5f0f\u4e0d\u540c\u3002<\/span><\/span><\/p>\n

\u4ea4\u53c9\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u9700\u8003\u8651\u7684\u56e0\u7d20\u5305\u62ec\uff1a\uff08<\/span>1<\/span>\uff09\u68c0\u9a8c\u6c34\u51c6<\/span>\u03b1<\/span>\uff0c\u901a\u5e38\u4e3a\u53cc\u4fa7<\/span>0.1<\/span>\uff1b\uff08<\/span>2<\/span>\uff09\u68c0\u9a8c\u6548\u80fd<\/span>1-\u03b2<\/span>\uff0c\u901a\u5e38\u4e3a<\/span>0.8<\/span>\u6216<\/span>0.9<\/span>\uff1b\uff08<\/span>3<\/span>\uff09\u4e2a\u4f53\u5185\u53d8\u5f02\uff08<\/span>Intra-subject coefficient of variation<\/span>\uff0c<\/span>CV%<\/span>\uff09\uff0c\u53ef\u57fa\u4e8e\u6587\u732e\u62a5\u9053\u6216\u9884\u8bd5\u9a8c\u7ed3\u679c\u8fdb\u884c\u4f30\u8ba1\uff1b\uff08<\/span>4<\/span>\uff09\u51e0\u4f55\u5747\u503c\u6bd4\uff08<\/span>Geometric mean ratio, GMR<\/span>\uff09\uff1b\uff08<\/span>5<\/span>\uff09\u7b49\u6548\u6027\u754c\u503c\u3002\u5e73\u884c\u7ec4\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u53ef\u53c2\u8003\u4e00\u822c\u8fde\u7eed\u578b\u53d8\u91cf\u7684\u6837\u672c\u91cf\u8ba1\u7b97\u516c\u5f0f\u3002<\/span><\/span><\/p>\n

\u5982\u679c\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u6ca1\u6709\u660e\u786e\u7684\u6837\u672c\u91cf\u8ba1\u7b97\u516c\u5f0f\uff0c\u4e5f\u53ef\u4ee5\u91c7\u7528\u8ba1\u7b97\u673a\u6a21\u62df\u7684\u65b9\u6cd5\u4f30\u8ba1\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u53d7\u8bd5\u8005\u8131\u843d<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u4e3a\u4e86\u907f\u514d\u7814\u7a76\u8fc7\u7a0b\u4e2d\u56e0\u53d7\u8bd5\u8005\u7684\u8131\u843d\u5bfc\u81f4\u6837\u672c\u91cf\u4e0d\u8db3\uff0c\u7533\u8bf7\u4eba\u5728\u8fdb\u884c\u6837\u672c\u91cf\u4f30\u8ba1\u65f6\u5e94\u8003\u8651\u9002\u5f53\u589e\u52a0\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u8bd5\u9a8c\u5f00\u59cb\u540e\u4e0d\u5e94\u518d\u8ffd\u52a0\u53d7\u8bd5\u8005\uff0c\u4e14\u4e0d\u5f97\u5728\u83b7\u53d6\u90e8\u5206\u53d7\u8bd5\u8005\u7684\u7ed3\u679c\u540e\u518d\u5165\u7ec4\u5176\u4ed6\u53d7\u8bd5\u8005\u3002\u5df2\u5206\u914d\u968f\u673a\u53f7\u7684\u53d7\u8bd5\u8005\u4e0d\u53ef\u4ee5\u88ab\u66ff\u4ee3\u3002<\/span><\/p>\n

\uff08\u56db\uff09\u6b8b\u7559\u6548\u5e94<\/span><\/strong><\/span><\/p>\n

\u4f7f\u7528\u4ea4\u53c9\u8bbe\u8ba1\u8fdb\u884c<\/span>BE<\/span>\u7814\u7a76\u901a\u8fc7\u6bcf\u4e2a\u53d7\u8bd5\u8005\u81ea\u8eab\u5bf9\u7167\u6765\u589e\u52a0\u6bd4\u8f83\u7684\u7cbe\u5ea6\uff0c\u5176\u57fa\u672c\u5047\u8bbe\u662f\u6240\u6bd4\u8f83\u7684\u5236\u5242\u5728\u4e0b\u4e00\u5468\u671f\u8bd5\u9a8c\u65f6\u5747\u4e0d\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u6216\u6b8b\u7559\u6548\u5e94\u76f8\u8fd1\u3002\u5982\u679c\u4ea4\u53c9\u8bbe\u8ba1\u4e2d\u5b58\u5728\u4e0d\u76f8\u7b49\u7684\u6b8b\u7559\u6548\u5e94\uff0c\u90a3\u4e48\u5bf9\u4e8e<\/span>GMR<\/span>\u7684\u4f30\u8ba1\u53ef\u80fd\u6709\u504f\u3002<\/span><\/span><\/p>\n

\u5982\u679c\u7814\u7a76\u8bbe\u8ba1\u65f6\u8ba4\u4e3a\u6709\u8bc1\u636e\u8bc1\u5b9e\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u7533\u8bf7\u4eba\u5e94\u5f53\u5728\u65b9\u6848\u4e2d\u63cf\u8ff0\u76f8\u5e94\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u5206\u6790\u65b9\u6cd5\u3002\u5982\u679c\u5728\u7edf\u8ba1\u5206\u6790\u65f6\u53d1\u73b0\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u7533\u8bf7\u4eba\u5e94\u5f53\u5206\u6790\u4ea7\u751f\u7684\u53ef\u80fd\u539f\u56e0\uff0c\u63d0\u4f9b\u76f8\u5e94\u7684\u5224\u65ad\u4f9d\u636e\uff0c\u8bc4\u4f30\u5176\u5bf9\u6700\u7ec8\u7ed3\u8bba\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u4e09\u3001  <\/span>\u6570\u636e\u5904\u7406\u548c\u5206\u6790<\/span><\/h1>\n

\uff08\u4e00\uff09\u6570\u636e\u96c6<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u7528\u4e8e\u7edf\u8ba1\u5206\u6790\u7684\u6570\u636e\u96c6\u4e8b\u5148\u9700\u8981\u5728\u65b9\u6848\u4e2d\u660e\u786e\u5b9a\u4e49\uff0c\u5305\u62ec\u5177\u4f53\u7684\u53d7\u8bd5\u8005\u6392\u9664\u6807\u51c6\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c<\/span>BE<\/span>\u7814\u7a76\u7684\u5206\u6790\u6570\u636e\u96c6\u5e94\u81f3\u5c11\u5305\u62ec\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u96c6\uff08<\/span>Pharmacokinetics Concentration Set<\/span>\uff0c<\/span>PKCS<\/span>\uff09\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6\uff08<\/span>Pharmacokinetics Parameter Set<\/span>\uff0c<\/span>PKPS<\/span>\uff09\u3001\u751f\u7269\u7b49\u6548\u6027\u96c6\uff08<\/span>Bioequivalence Set<\/span>\uff0c<\/span>BES<\/span>\uff09\u3001\u5b89\u5168\u96c6\uff08<\/span>Safety Set<\/span>\uff0c\u7b80\u79f0<\/span>SS<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u96c6\uff08<\/span>PKCS<\/span>\uff09\uff1a\u5305\u62ec\u6240\u6709\u968f\u673a\u5316\uff0c\u4e14\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u7814\u7a76\u836f\u7269\uff0c\u5e76\u6709\u81f3\u5c11\u4e00\u4e2a\u7528\u836f\u540e\u6709\u6548\u7684\u68c0\u6d4b\u6210\u5206\u6d53\u5ea6\u6570\u636e\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u4e3a\u63cf\u8ff0\u6027\u7edf\u8ba1\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u6570\u636e\u3002<\/span><\/span><\/p>\n

\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6\uff08<\/span>PKPS<\/span>\uff09\uff1a\u5305\u62ec\u6240\u6709\u968f\u673a\u5316\uff0c\u4e14\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u7814\u7a76\u836f\u7269\uff0c\u5e76\u6709\u81f3\u5c11\u4e00\u4e2a\u6709\u6548\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u5728\u4e8e\u63cf\u8ff0\u6027\u7edf\u8ba1\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u3002<\/span><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u96c6\uff08<\/span>BES<\/span>\uff09\uff1a\u5305\u62ec\u5b8c\u6210\u6240\u6709\u5468\u671f\u8bd5\u9a8c\u5e76\u63d0\u4f9b\u5b8c\u6574\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u662f\u63a8\u65ad\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u662f\u5426\u7b49\u6548\u7684\u4e3b\u8981\u6570\u636e\u96c6\u3002\u672c\u6570\u636e\u96c6\u5e94\u9488\u5bf9\u4e0d\u540c\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u8bbe\u5b9a\uff0c\u4f8b\u5982\u7814\u7a76\u9488\u5bf9<\/span>Cmax<\/sub><\/span>\u3001<\/span>AUC0-t<\/sub><\/span>\u548c<\/span>AUC0-<\/sub><\/span>\u221e<\/span><\/sub>\u4e09\u4e2a\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u8fdb\u884c\u5206\u6790\uff0c\u5219\u672c\u7814\u7a76\u5e94\u5305\u542b\u4e09\u4e2a<\/span>BES<\/span>\u3002<\/span><\/span><\/p>\n

\u5b89\u5168\u96c6\uff08<\/span>SS<\/span>\uff09\uff1a\u5305\u62ec\u6240\u6709\u968f\u673a\u5316\u540e\u81f3\u5c11\u63a5\u53d7\u4e00\u6b21\u7814\u7a76\u836f\u7269\u4e14\u6709\u5b89\u5168\u6027\u8bc4\u4ef7\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u5728\u4e8e\u5206\u6790\u8bd5\u9a8c\u7684\u5b89\u5168\u6027\u3002<\/span><\/span><\/p>\n

\uff08\u4e8c\uff09\u6570\u636e\u8f6c\u6362<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5efa\u8bae\u5bf9\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\uff08\u5982<\/span>AUC<\/span>\u548c<\/span>Cmax<\/sub><\/span>\uff09\u4f7f\u7528\u81ea\u7136\u5bf9\u6570\u8fdb\u884c\u6570\u636e\u8f6c\u6362\u3002\u9009\u62e9\u7684\u5bf9\u6570\u8f6c\u6362\u65b9\u5f0f\u5e94\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u4fdd\u6301\u4e00\u81f4\uff0c\u4e14\u9700\u5728\u65b9\u6848\u4e2d\u6307\u660e\u3002\u5728\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\uff0c\u7531\u4e8e\u6837\u672c\u91cf\u8f83\u5c11\uff0c\u96be\u4ee5\u786e\u5b9a\u6570\u636e\u7684\u5206\u5e03\u3002\u56e0\u6b64\uff0c\u4e0d\u5efa\u8bae\u4ee5\u5bf9\u6570\u8f6c\u6362\u540e\u6570\u636e\u4e0d\u670d\u4ece\u6b63\u6001\u5206\u5e03\uff0c\u6216\u539f\u59cb\u6570\u636e\u670d\u4ece\u6b63\u6001\u5206\u5e03\u4e3a\u7531\uff0c\u800c\u4f7f\u7528\u539f\u59cb\u6570\u636e\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\u3002<\/span><\/span><\/p>\n

\uff08\u4e09\uff09\u7edf\u8ba1\u5047\u8bbe\u4e0e\u63a8\u65ad<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e73\u5747\u751f\u7269\u7b49\u6548\u8981\u6c42\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u5dee\u5f02\u5728\u4e00\u5b9a\u53ef\u63a5\u53d7\u8303\u56f4\u5185\uff0c\u901a\u8fc7\u4ee5\u4e0b\u5047\u8bbe\u68c0\u9a8c\u6765\u8fdb\u884c\u7edf\u8ba1\u63a8\u65ad\u3002<\/span><\/p>\n

\u539f\u5047\u8bbe<\/span>H<\/span><\/em>0<\/span><\/sub>\uff1a<\/span>                             <\/span><\/span><\/p>\n

\u5907\u62e9\u5047\u8bbe<\/span>H<\/span><\/em>1<\/span><\/sub>\uff1a<\/span><\/span><\/span><\/p>\n

\u5176\u4e2d<\/span>\u03bcT<\/sub><\/span><\/em>\u4e3a\u53d7\u8bd5\u5236\u5242\u5bf9\u6570\u53d8\u6362\u540e\u836f\u4ee3\u53c2\u6570\u603b\u4f53\u5747\u6570\uff0c<\/span>\u03bcR<\/sub><\/span><\/em>\u4e3a\u53c2\u6bd4\u5236\u5242\u5bf9\u6570\u53d8\u6362\u540e\u836f\u4ee3\u53c2\u6570\u603b\u4f53\u5747\u6570\uff0c\u03b8<\/em>\u4e3a\u751f\u7269\u7b49\u6548\u6027\u754c\u503c\u3002\u5728\u8bbe\u5b9a\u7684\u68c0\u9a8c\u6c34\u51c6\u4e0b\uff0c\u82e5\u62d2\u7edd\u539f\u5047\u8bbe<\/span>H<\/span><\/em>0<\/span><\/sub>\uff0c\u5219\u8868\u660e\u751f\u7269\u7b49\u6548\u3002\u4e00\u822c\u79f0<\/span><\/span>\u4e3a\u5e73\u5747\u751f\u7269\u7b49\u6548\u6807\u51c6\uff0c\u8be5\u6807\u51c6\u7b49\u4ef7\u4e8e<\/span>–\u03b8<\/em><\/span>\u2264\u03bc<\/span><\/em>T<\/span><\/sub><\/em>–<\/span><\/em>\u03bc<\/span><\/em>R<\/span><\/sub><\/em>\u2264<\/span><\/em>\u03b8<\/span><\/em>\u3002\u901a\u5e38\u8bbe\u5b9a<\/span>\u03b8<\/span><\/em>=ln(1.25)<\/span>\uff0c<\/span>–\u03b8<\/em>=ln(0.8)<\/span>\u3002\u8be5\u6807\u51c6\u540c\u65f6\u9002\u7528\u4e8e<\/span>Cmax<\/sub><\/span>\u548c<\/span>AUC<\/span>\u3002<\/span><\/span><\/p>\n

\u5bf9<\/span>Tmax<\/sub><\/span>\u7684\u5206\u6790\u901a\u5e38\u91c7\u7528\u975e\u53c2\u6570\u65b9\u6cd5\u8fdb\u884c\u5dee\u5f02\u6027\u68c0\u9a8c\u3002<\/span><\/span><\/p>\n

\uff08\u56db\uff09\u6570\u636e\u5206\u6790<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

1.<\/span>\u6982\u8ff0<\/span><\/span><\/p>\n

\u5bf9\u4e8e\u4e0a\u6587\u63d0\u5230\u7684\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\uff0c\u901a\u5e38\u662f\u6784\u5efa\u03bc<\/em><\/span>T<\/span><\/sub><\/em>–<\/span>\u03bc<\/span><\/em>R<\/span><\/sub><\/em>\u7684\u53cc\u4fa7<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\uff0c\u82e5\u6b64\u7f6e\u4fe1\u533a\u95f4\u843d\u5728\u533a\u95f4<\/span><\/span>\u5185\uff0c\u5219\u53ef\u63a8\u65ad\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u6ee1\u8db3\u751f\u7269\u7b49\u6548\u3002\u6b64\u65b9\u6cd5\u7b49\u4ef7\u4e8e\u5728<\/span>0.05<\/span>\u7684\u68c0\u9a8c\u6c34\u51c6\u4e0b\u8fdb\u884c\u53cc\u5355\u4fa7\u5047\u8bbe\u68c0\u9a8c\u3002\u5e94\u6839\u636e\u4e0d\u540c\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u9009\u62e9\u6070\u5f53\u7684\u7f6e\u4fe1\u533a\u95f4\u8ba1\u7b97\u65b9\u6cd5\u3002\u8ba1\u7b97\u51fa\u03bc<\/em><\/span>T<\/span><\/sub><\/em>–<\/span>\u03bc<\/span><\/em>R<\/span><\/sub><\/em>\u7684\u53cc\u4fa7<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u540e\uff0c\u53ef\u901a\u8fc7\u9006\u5bf9\u6570\u53d8\u6362\uff08\u6307\u6570\u53d8\u6362\uff09\u5f97\u5230\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u539f\u59cb\u6570\u636e\u7684<\/span>GMR<\/span>\u7684\u53cc\u4fa7<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u3002<\/span><\/span><\/p>\n

2.<\/span>\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5bf9\u4e8e\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u5efa\u8bae\u4f7f\u7528\u7ebf\u6027\u6df7\u5408\u6548\u5e94\u6a21\u578b\u8fdb\u884c\u5206\u6790\u8ba1\u7b97\u3002<\/span><\/p>\n

3.<\/span>\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5efa\u8bae\u91c7\u7528\u57fa\u4e8e\u6b63\u6001\u5206\u5e03\u5747\u6570\u5dee\u503c\u7684\u7f6e\u4fe1\u533a\u95f4\u6784\u5efa\u65b9\u6cd5\u3002<\/span><\/p>\n

\uff08\u4e94\uff09\u79bb\u7fa4\u6570\u636e\u5904\u7406<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

BE<\/span>\u7814\u7a76\u4e2d\u901a\u5e38\u4e0d\u5efa\u8bae\u5254<\/span><\/span>\u9664\u79bb\u7fa4\u503c\u3002<\/span><\/p>\n

\u5fc5\u8981\u65f6\u9700\u8981\u9488\u5bf9\u79bb\u7fa4\u503c\u8fdb\u884c\u654f\u611f\u6027\u5206\u6790\uff0c\u5373\u8bc4\u4ef7\u5254\u9664\u548c\u4e0d\u5254\u9664\u79bb\u7fa4\u503c\u5bf9\u751f\u7269\u7b49\u6548\u6027\u7ed3\u679c\u7684\u5f71\u54cd\u3002\u5982\u679c\u7ed3\u8bba\u4e0d\u4e00\u81f4\uff0c\u9700\u89e3\u91ca\u8bf4\u660e\u5e76\u5206\u6790\u539f\u56e0\u3002<\/span><\/p>\n

\uff08\u516d\uff09\u5176\u4ed6\u95ee\u9898<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5982\u679c\u4e00\u4e2a\u4ea4\u53c9\u8bbe\u8ba1\u662f\u5728\u4e24\u4e2a\u53ca\u4ee5\u4e0a\u7684\u4e2d\u5fc3\u8fdb\u884c\uff0c\u7edf\u8ba1\u6a21\u578b\u4e2d\u5e94\u8be5\u8003\u8651\u4e2d\u5fc3\u6548\u5e94\u3002\u6240\u7528\u6a21\u578b\u5e94\u8be5\u80fd\u4f30\u8ba1\u4e0d\u540c\u4e2d\u5fc3\u7684\u6548\u5e94\uff0c\u53cd\u6620\u4e0d\u540c\u4e2d\u5fc3\u7684\u5b9e\u9645\u60c5\u51b5\uff0c\u5e76\u8bf4\u660e\u6765\u81ea\u4e0d\u540c\u4e2d\u5fc3\u7684\u8bd5\u9a8c\u6570\u636e\u662f\u5426\u53ef\u4ee5\u5408\u5e76\u8fdb\u884c\u5206\u6790\u3002<\/span><\/p>\n

\u5982\u679c\u5b58\u5728\u591a\u79cd\u53d7\u8bd5\u5236\u5242\u548c<\/span>\/<\/span>\u6216\u591a\u79cd\u53c2\u6bd4\u5236\u5242\uff0c\u901a\u5e38\u4f1a\u6709\u591a\u4e2a\u751f\u7269\u7b49\u6548\u7684\u5047\u8bbe\u68c0\u9a8c\u3002\u82e5\u8bd5\u9a8c\u8981\u6c42\u8fbe\u5230\u5168\u90e8\u751f\u7269\u7b49\u6548\uff0c\u5219\u65e0\u9700\u8fdb\u884c<\/span>I<\/span>\u7c7b\u9519\u8bef\u7684\u8c03\u6574\uff1b\u82e5\u8bd5\u9a8c\u4e0d\u8981\u6c42\u8fbe\u5230\u5168\u90e8\u751f\u7269\u7b49\u6548\uff0c\u5219\u9700\u5bf9<\/span>I<\/span>\u7c7b\u9519\u8bef\u8fdb\u884c\u8c03\u6574\uff0c\u8c03\u6574\u7684\u65b9\u6cd5\u6709<\/span>Bonferroni<\/span>\u6cd5\u3001<\/span>Hochberg<\/span>\u6cd5\u7b49\u3002<\/span><\/span><\/p>\n

\u56db\u3001  <\/span>\u7ed3\u679c\u62a5\u544a<\/span><\/h1>\n

\u7ed3\u679c\u62a5\u544a\u4e2d\u5e94\u5bf9\u4ee5\u4e0b\u5185\u5bb9\u8fdb\u884c\u8be6\u7ec6\u8bf4\u660e\u3002<\/span><\/p>\n

\uff08\u4e00\uff09\u968f\u673a\u5316<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e94\u5177\u4f53\u8bf4\u660e\u8bd5\u9a8c\u7528\u7684\u968f\u673a\u5316\u7cfb\u7edf\u548c\u968f\u673a\u5316\u65b9\u6848\uff0c\u5305\u62ec\u968f\u673a\u5316\u63a7\u5236\u7684\u56e0\u7d20\u3001\u533a\u7ec4\u3001\u79cd\u5b50\u6570\u7b49\uff0c\u5e76\u9644\u6709\u968f\u673a\u5316\u6570\u5b57\u8868\u3002<\/span><\/p>\n

\u968f\u673a\u5316\u7684\u7ed3\u679c\u5e94\u7528\u8868\u683c\u63cf\u8ff0\uff0c\u5176\u4e2d\u5305\u542b\u53d7\u8bd5\u8005\u7f16\u53f7\u3001\u6bcf\u4e00\u5468\u671f\u7684\u7528\u836f\u60c5\u51b5\uff0c\u4ee5\u53ca\u968f\u673a\u5316\u63a7\u5236\u7684\u56e0\u7d20\u7b49\u3002\u968f\u673a\u5316\u7ed3\u679c\u53ef\u5728\u9644\u5f55\u4e2d\u5c55\u73b0\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u7edf\u8ba1\u5b66\u65b9\u6cd5<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e94\u8bf4\u660e\u6240\u91c7\u7528\u7684\u7edf\u8ba1\u5b66\u65b9\u6cd5\uff0c\u5305\u62ec\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u8ba1\u7b97\u65b9\u6cd5\u3001\u5206\u6790\u6a21\u578b\u548c\u7b49\u6548\u6027\u68c0\u9a8c\u65b9\u6cd5\u3001\u5bf9\u6570\u8f6c\u6362\u7b49\u5185\u5bb9\u3002\u8fd8\u9700\u8bf4\u660e\u4f7f\u7528\u8f6f\u4ef6\u7684\u540d\u79f0\u4e0e\u7248\u672c\u53f7\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u7edf\u8ba1\u5206\u6790\u7ed3\u679c<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e94\u63d0\u4f9b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7ed9\u836f\u540e\u7684\u68c0\u6d4b\u6210\u5206\u6d53\u5ea6\u68c0\u6d4b\u7ed3\u679c\uff0c\u4f7f\u7528\u539f\u59cb\u6570\u636e\u5c55\u73b0\u3002\u5728\u9644\u5f55\u4e2d\u5e94\u540c\u65f6\u7ed9\u51fa\u7b97\u6570\u5750\u6807\u4ee5\u53ca\u5bf9\u6570\u5750\u6807\u4e0b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7ed9\u836f\u540e\u7684\u836f\u65f6\u66f2\u7ebf\u3001\u4e0d\u540c\u836f\u7269\u5236\u5242\u7684\u5e73\u5747\u836f\u65f6\u66f2\u7ebf\u3002<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7ed3\u679c\uff0c\u4e5f\u5e94\u4f7f\u7528\u539f\u59cb\u6570\u636e\u5c55\u73b0\u3002\u5bf9\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u63cf\u8ff0\u5e94\u5305\u62ec\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u7b97\u672f\u5747\u503c\u3001\u51e0\u4f55\u5747\u503c\u3001\u6807\u51c6\u5dee\u548c\u53d8\u5f02\u7cfb\u6570\u3002<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u5305\u542b\u5e8f\u5217\u5185\u5d4c\u5957\u53d7\u8bd5\u8005\u3001\u5e8f\u5217\u3001\u5468\u671f\u548c\u5236\u5242\u56e0\u7d20\u7684\u6df7\u5408\u6548\u5e94\u6a21\u578b\u7ed3\u679c\u3002\u82e5\u5b58\u5728\u5176\u4ed6\u8fd8\u9700\u8003\u8651\u7684\u56e0\u7d20\uff0c\u4e5f\u5e94\u5305\u542b\u5728\u6a21\u578b\u4e2d\u3002<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u51e0\u4f55\u5747\u503c\u6bd4\u53ca\u5176\u7f6e\u4fe1\u533a\u95f4\u4f30\u8ba1\u7ed3\u679c\u3002<\/span><\/p>\n

\u4e94\u3001  <\/span>\u6570\u636e\u7ba1\u7406<\/span><\/h1>\n

\u4ee5\u6ce8\u518c\u4e0a\u5e02\u4e3a\u76ee\u7684\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u6570\u636e\u7ba1\u7406\u8981\u6c42\u5e94\u4e0e\u4e00\u822c\u4e34\u5e8a\u8bd5\u9a8c\u76f8\u540c\uff0c\u53ef\u53c2\u8003\u300a\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u5de5\u4f5c\u6280\u672f\u6307\u5357\u300b\u3002<\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u751f\u7269\u6837\u672c\u5206\u6790\u7b49\u6570\u636e\u4e3a\u5916\u90e8\u6570\u636e\uff0c\u5728\u68c0\u6d4b\u548c\u4f20\u8f93\u8fc7\u7a0b\u4e2d\u5e94\u4fdd\u6301\u76f2\u6001\u5e76\u6309\u7167\u63d0\u524d\u5236\u5b9a\u7684\u4f20\u8f93\u534f\u8bae\u8fdb\u884c\u6570\u636e\u4f20\u8f93\u3002\u8bd5\u9a8c\u6d89\u53ca\u5230\u7684\u751f\u7269\u6837\u672c\u68c0\u6d4b\u3001\u4e34\u5e8a\u6570\u636e\u4f20\u8f93\u548c\u7edf\u8ba1\u5206\u6790\u76f8\u5173\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u5e94\u7ecf\u8fc7\u9a8c\u8bc1\u5e76\u4fdd\u6301\u9a8c\u8bc1\u72b6\u6001\u3002<\/span><\/p>\n

\u516d\u3001  <\/span>\u672f\u8bed\u8868<\/span><\/h1>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u82f1\u6587\u5168\u79f0<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u82f1\u6587\u7f29\u5199<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u4e2d\u6587\u5168\u79f0<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<\/thead>\n

\n

Bioequivalence<\/span><\/p>\n<\/td>\n

\n

BE<\/span><\/p>\n<\/td>\n

\n

\u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Average Bioequivalence<\/span><\/p>\n<\/td>\n

\n

ABE<\/span><\/p>\n<\/td>\n

\n

\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Population Bioequivalence<\/span><\/p>\n<\/td>\n

\n

PBE<\/span><\/p>\n<\/td>\n

\n

\u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Geometric mean ratio<\/span><\/p>\n<\/td>\n

\n

GMR<\/span><\/p>\n<\/td>\n

\n

\u51e0\u4f55\u5747\u503c\u6bd4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Intra-subject coefficient of variation<\/span><\/p>\n<\/td>\n

\n

CV%<\/span><\/p>\n<\/td>\n

\n

\u4e2a\u4f53\u5185\u53d8\u5f02<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Bioequivalence Set<\/span><\/p>\n<\/td>\n

\n

BES<\/span><\/p>\n<\/td>\n

\n

\u751f\u7269\u7b49\u6548\u6027\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pharmacokinetics Concentration Set<\/span><\/p>\n<\/td>\n

\n

PKCS<\/span><\/p>\n<\/td>\n

\n

\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pharmacokinetics Parameter Set<\/span><\/p>\n<\/td>\n

\n

PKPS<\/span><\/p>\n<\/td>\n

\n

\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Safety Set<\/span><\/p>\n<\/td>\n

\n

SS<\/span><\/p>\n<\/td>\n

\n

\u5b89\u5168\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Subject nested in sequence<\/span><\/p>\n<\/td>\n

\n

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

\n

\u5e8f\u5217\u5185\u5d4c\u5957\u53d7\u8bd5\u8005<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u9644\u4ef62\uff1a      <\/strong><\/span>    <\/strong><\/p>\n

 <\/strong><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219<\/span><\/strong> <\/strong><\/p>\n

(<\/strong>\u5f81\u6c42\u610f\u89c1\u7a3f<\/span><\/strong>)<\/strong> <\/strong><\/p>\n

\u4e8c\u3007\u4e00\u516b\u5e74\u516d\u6708<\/span><\/strong> <\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n


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

\u4e00\u3001  <\/span>\u6982\u8ff0<\/span><\/h1>\n

\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>Bioequivalence, BE<\/span>\uff09\u7814\u7a76\u662f\u6bd4\u8f83\u53d7\u8bd5\u5236\u5242\uff08<\/span>T<\/span>\uff09\u4e0e\u53c2\u6bd4\u5236\u5242\uff08<\/span>R<\/span>\uff09\u7684\u5438\u6536\u901f\u5ea6\u548c\u5438\u6536\u7a0b\u5ea6\u5dee\u5f02\u662f\u5426\u5728\u53ef\u63a5\u53d7\u8303\u56f4\u5185\u7684\u7814\u7a76\uff0c\u53ef\u7528\u4e8e\u5316\u5b66\u836f\u7269\u4eff\u5236\u836f\u7684\u4e0a\u5e02\u7533\u8bf7\uff0c\u4e5f\u53ef\u7528\u4e8e\u5df2\u4e0a\u5e02\u836f\u7269\u7684\u53d8\u66f4\uff08\u5982\u65b0\u589e\u89c4\u683c\u3001\u65b0\u589e\u5242\u578b\u3001\u65b0\u7684\u7ed9\u836f\u9014\u5f84\uff09\u7533\u8bf7\u3002<\/span><\/span><\/p>\n

\u76ee\u524d\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u901a\u5e38\u63a8\u8350\u4f7f\u7528\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>Average Bioequivalence, ABE<\/span>\uff09\u65b9\u6cd5\u3002\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027\u65b9\u6cd5\u53ea\u6bd4\u8f83\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u5e73\u5747\u6c34\u5e73\uff0c\u672a\u8003\u8651\u4e2a\u4f53\u5185\u53d8\u5f02\u53ca\u4e2a\u4f53\u4e0e\u5236\u5242\u7684\u4ea4\u4e92\u4f5c\u7528\u5f15\u8d77\u7684\u53d8\u5f02\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u53ef\u80fd\u9700\u8981\u8003\u8651\u5176\u4ed6\u5206\u6790\u65b9\u6cd5\u3002\u4f8b\u5982\u6c14\u96fe\u5242\u7684\u4f53\u5916<\/span>BE<\/span>\u7814\u7a76\u53ef\u91c7\u7528\u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027\uff08<\/span>Population Bioequivalence<\/span>\uff0c<\/span>PBE<\/span>\uff09\u65b9\u6cd5\uff0c\u4ee5\u8bc4\u4ef7\u5236\u5242\u95f4\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u5e73\u5747\u6c34\u5e73\u53ca\u4e2a\u4f53\u5185\u53d8\u5f02\u662f\u5426\u7b49\u6548\u3002<\/span><\/span><\/p>\n

\u672c\u6307\u5bfc\u539f\u5219\u65e8\u5728\u4e3a\u4ee5\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u4e3a\u7ec8\u70b9\u8bc4\u4ef7\u6307\u6807\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7814\u7a76\u8bbe\u8ba1\u3001\u6570\u636e\u5206\u6790\u548c\u7ed3\u679c\u62a5\u544a\u63d0\u4f9b\u6280\u672f\u6307\u5bfc\uff0c\u662f\u5bf9\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6570\u636e\u8d44\u6599\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\u7684\u4e00\u822c\u539f\u5219\u3002\u5728\u5f00\u5c55\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u65f6\uff0c\u9664\u53c2\u8003\u672c\u6307\u5bfc\u539f\u5219\u7684\u5185\u5bb9\u5916\uff0c\u5c1a\u5e94\u7efc\u5408\u53c2\u8003\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\u548c\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\u7b49\u76f8\u5173\u6307\u5bfc\u539f\u5219\u3002<\/span><\/p>\n

\u4e8c\u3001  <\/span>\u7814\u7a76\u8bbe\u8ba1<\/span><\/h1>\n

\uff08\u4e00\uff09\u603b\u4f53\u8bbe\u8ba1\u8003\u8651<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u53ef\u91c7\u7528\u4ea4\u53c9\u8bbe\u8ba1\u6216\u8005\u5e73\u884c\u7ec4\u8bbe\u8ba1\u3002<\/span><\/p>\n

1.<\/span>\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e00\u822c\u5efa\u8bae\u91c7\u7528\u4ea4\u53c9\u8bbe\u8ba1\u7684\u65b9\u6cd5\u3002\u4ea4\u53c9\u8bbe\u8ba1\u7684\u4f18\u52bf\u5305\u62ec\uff1a\u53ef\u4ee5\u6709\u6548\u51cf\u5c11\u4e2a\u4f53\u95f4\u53d8\u5f02\u7ed9\u8bd5\u9a8c\u8bc4\u4ef7\u5e26\u6765\u7684\u504f\u501a\uff1b\u5728\u6837\u672c\u91cf\u76f8\u7b49\u7684\u60c5\u51b5\u4e0b\uff0c\u4f7f\u7528\u4ea4\u53c9\u8bbe\u8ba1\u6bd4\u5e73\u884c\u7ec4\u8bbe\u8ba1\u5177\u6709\u66f4\u9ad8\u7684\u68c0\u9a8c\u6548\u80fd\u3002<\/span><\/p>\n

\u4e24\u5236\u5242\u3001\u4e24\u5468\u671f\u3001\u4e24\u5e8f\u5217\u4ea4\u53c9\u8bbe\u8ba1\u662f\u4e00\u79cd\u5e38\u89c1\u7684\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u89c1\u8868<\/span>1<\/span>\u3002<\/span><\/span><\/p>\n

\u8868<\/span>1<\/span>\u4e24\u5236\u5242\u3001\u4e24\u5468\u671f\u3001\u4e24\u5e8f\u5217\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

2<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span><\/p>\n<\/td>\n

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

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

\n

T<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u5982\u679c\u9700\u8981\u51c6\u786e\u4f30\u8ba1\u67d0\u4e00\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u53ef\u91c7\u7528\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u3002\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1\u5305\u62ec\u90e8\u5206\u91cd\u590d\uff08\u5982\u4e24\u5236\u5242\u3001\u4e09\u5468\u671f\u3001\u4e09\u5e8f\u5217\uff09\u6216\u8005\u5b8c\u5168\u91cd\u590d\uff08\u5982\u4e24\u5236\u5242\u3001\u56db\u5468\u671f\u3001\u4e24\u5e8f\u5217\uff09\uff0c\u89c1\u8868<\/span>2<\/span>\u548c\u8868<\/span>3<\/span>\u3002<\/span><\/span><\/p>\n

\u8868<\/span>2<\/span>\u4e24\u5236\u5242\u3001\u4e09\u5468\u671f\u3001\u4e09\u5e8f\u5217\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/strong><\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

       1<\/span><\/p>\n<\/td>\n

\n

        2<\/span><\/p>\n<\/td>\n

\n

        3<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

1<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

3<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

T<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u8868<\/span>3<\/span>\u4e24\u5236\u5242\u3001\u56db\u5468\u671f\u3001\u4e24\u5e8f\u5217\u91cd\u590d\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5e8f\u5217<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u5468\u671f<\/span><\/strong><\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

        1<\/span><\/p>\n<\/td>\n

\n

        2<\/span><\/p>\n<\/td>\n

\n

         3<\/span><\/p>\n<\/td>\n

\n

      4<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n<\/thead>\n
\n

1<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

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

\n

R<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

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

\n

T<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

2.<\/span>\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5728\u67d0\u4e9b\u7279\u5b9a\u60c5\u51b5\u4e0b\uff08\u4f8b\u5982\u534a\u8870\u671f\u8f83\u957f\u7684\u836f\u7269\uff09\uff0c\u4e5f\u53ef\u4ee5\u4f7f\u7528\u5e73\u884c\u7ec4\u8bbe\u8ba1\u3002\u5e73\u884c\u7ec4\u8bbe\u8ba1\u56e0\u4e2a\u4f53\u95f4\u53d8\u5f02\u7ed9\u8bd5\u9a8c\u5e26\u6765\u7684\u5f71\u54cd\u8f83\u4ea4\u53c9\u8bbe\u8ba1\u5927\uff0c\u5e94\u6709\u66f4\u4e25\u683c\u7684\u53d7\u8bd5\u8005\u5165\u9009\u6761\u4ef6\uff0c\u5982\u5e74\u9f84\u3001\u6027\u522b\u3001\u4f53\u91cd\u3001\u75be\u75c5\u53f2\u7b49\uff0c\u4e14\u9700\u4f7f\u7528\u5408\u7406\u7684\u968f\u673a\u5316\u65b9\u6848\u786e\u4fdd\u7ec4\u95f4\u7684\u57fa\u7ebf\u6c34\u5e73\u5747\u8861\u4ee5\u5f97\u5230\u66f4\u597d\u7684\u7ec4\u95f4\u53ef\u6bd4\u6027\u3002<\/span><\/p>\n

3.<\/span>\u5176\u4ed6\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5982\u679c\u91c7\u7528\u9002\u5e94\u6027\u8bbe\u8ba1\u7b49\u5176\u4ed6\u8bbe\u8ba1\u65b9\u6cd5\uff0c\u53ef\u53c2\u8003\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\u751f\u7269\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\u300b\uff0c\u4e14\u5e94\u4e8b\u5148\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u6837\u672c\u91cf<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u8bd5\u9a8c\u524d\u9700\u5145\u5206\u4f30\u8ba1\u6240\u9700\u7684\u6837\u672c\u91cf\uff0c\u4ee5\u4fdd\u8bc1\u8db3\u591f\u7684\u68c0\u9a8c\u6548\u80fd\uff0c\u5e76\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u8be6\u7ec6\u8bf4\u660e\u6837\u672c\u91cf\u4f30\u8ba1\u65b9\u6cd5\u548c\u7ed3\u679c\u3002\u4f7f\u7528<\/span>ABE<\/span>\u65b9\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u65f6\uff0c\u5e94\u57fa\u4e8e\u660e\u786e\u7684\u516c\u5f0f\u5408\u7406\u4f30\u8ba1\u6837\u672c\u91cf\u3002\u4e0d\u540c\u7684\u8bbe\u8ba1\uff0c\u5bf9\u5e94\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u516c\u5f0f\u4e0d\u540c\u3002<\/span><\/span><\/p>\n

\u4ea4\u53c9\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u9700\u8003\u8651\u7684\u56e0\u7d20\u5305\u62ec\uff1a\uff08<\/span>1<\/span>\uff09\u68c0\u9a8c\u6c34\u51c6<\/span>\u03b1<\/span>\uff0c\u901a\u5e38\u4e3a\u53cc\u4fa7<\/span>0.1<\/span>\uff1b\uff08<\/span>2<\/span>\uff09\u68c0\u9a8c\u6548\u80fd<\/span>1-\u03b2<\/span>\uff0c\u901a\u5e38\u4e3a<\/span>0.8<\/span>\u6216<\/span>0.9<\/span>\uff1b\uff08<\/span>3<\/span>\uff09\u4e2a\u4f53\u5185\u53d8\u5f02\uff08<\/span>Intra-subject coefficient of variation<\/span>\uff0c<\/span>CV%<\/span>\uff09\uff0c\u53ef\u57fa\u4e8e\u6587\u732e\u62a5\u9053\u6216\u9884\u8bd5\u9a8c\u7ed3\u679c\u8fdb\u884c\u4f30\u8ba1\uff1b\uff08<\/span>4<\/span>\uff09\u51e0\u4f55\u5747\u503c\u6bd4\uff08<\/span>Geometric mean ratio, GMR<\/span>\uff09\uff1b\uff08<\/span>5<\/span>\uff09\u7b49\u6548\u6027\u754c\u503c\u3002\u5e73\u884c\u7ec4\u8bbe\u8ba1\u7684\u6837\u672c\u91cf\u4f30\u8ba1\u53ef\u53c2\u8003\u4e00\u822c\u8fde\u7eed\u578b\u53d8\u91cf\u7684\u6837\u672c\u91cf\u8ba1\u7b97\u516c\u5f0f\u3002<\/span><\/span><\/p>\n

\u5982\u679c\u4f7f\u7528\u7684\u5206\u6790\u65b9\u6cd5\u6ca1\u6709\u660e\u786e\u7684\u6837\u672c\u91cf\u8ba1\u7b97\u516c\u5f0f\uff0c\u4e5f\u53ef\u4ee5\u91c7\u7528\u8ba1\u7b97\u673a\u6a21\u62df\u7684\u65b9\u6cd5\u4f30\u8ba1\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u53d7\u8bd5\u8005\u8131\u843d<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u4e3a\u4e86\u907f\u514d\u7814\u7a76\u8fc7\u7a0b\u4e2d\u56e0\u53d7\u8bd5\u8005\u7684\u8131\u843d\u5bfc\u81f4\u6837\u672c\u91cf\u4e0d\u8db3\uff0c\u7533\u8bf7\u4eba\u5728\u8fdb\u884c\u6837\u672c\u91cf\u4f30\u8ba1\u65f6\u5e94\u8003\u8651\u9002\u5f53\u589e\u52a0\u6837\u672c\u91cf\u3002<\/span><\/p>\n

\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u8bd5\u9a8c\u5f00\u59cb\u540e\u4e0d\u5e94\u518d\u8ffd\u52a0\u53d7\u8bd5\u8005\uff0c\u4e14\u4e0d\u5f97\u5728\u83b7\u53d6\u90e8\u5206\u53d7\u8bd5\u8005\u7684\u7ed3\u679c\u540e\u518d\u5165\u7ec4\u5176\u4ed6\u53d7\u8bd5\u8005\u3002\u5df2\u5206\u914d\u968f\u673a\u53f7\u7684\u53d7\u8bd5\u8005\u4e0d\u53ef\u4ee5\u88ab\u66ff\u4ee3\u3002<\/span><\/p>\n

\uff08\u56db\uff09\u6b8b\u7559\u6548\u5e94<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u4f7f\u7528\u4ea4\u53c9\u8bbe\u8ba1\u8fdb\u884c<\/span>BE<\/span>\u7814\u7a76\u901a\u8fc7\u6bcf\u4e2a\u53d7\u8bd5\u8005\u81ea\u8eab\u5bf9\u7167\u6765\u589e\u52a0\u6bd4\u8f83\u7684\u7cbe\u5ea6\uff0c\u5176\u57fa\u672c\u5047\u8bbe\u662f\u6240\u6bd4\u8f83\u7684\u5236\u5242\u5728\u4e0b\u4e00\u5468\u671f\u8bd5\u9a8c\u65f6\u5747\u4e0d\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u6216\u6b8b\u7559\u6548\u5e94\u76f8\u8fd1\u3002\u5982\u679c\u4ea4\u53c9\u8bbe\u8ba1\u4e2d\u5b58\u5728\u4e0d\u76f8\u7b49\u7684\u6b8b\u7559\u6548\u5e94\uff0c\u90a3\u4e48\u5bf9\u4e8e<\/span>GMR<\/span>\u7684\u4f30\u8ba1\u53ef\u80fd\u6709\u504f\u3002<\/span><\/span><\/p>\n

\u5982\u679c\u7814\u7a76\u8bbe\u8ba1\u65f6\u8ba4\u4e3a\u6709\u8bc1\u636e\u8bc1\u5b9e\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u7533\u8bf7\u4eba\u5e94\u5f53\u5728\u65b9\u6848\u4e2d\u63cf\u8ff0\u76f8\u5e94\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u5206\u6790\u65b9\u6cd5\u3002\u5982\u679c\u5728\u7edf\u8ba1\u5206\u6790\u65f6\u53d1\u73b0\u5b58\u5728\u6b8b\u7559\u6548\u5e94\uff0c\u7533\u8bf7\u4eba\u5e94\u5f53\u5206\u6790\u4ea7\u751f\u7684\u53ef\u80fd\u539f\u56e0\uff0c\u63d0\u4f9b\u76f8\u5e94\u7684\u5224\u65ad\u4f9d\u636e\uff0c\u8bc4\u4f30\u5176\u5bf9\u6700\u7ec8\u7ed3\u8bba\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u4e09\u3001  <\/span>\u6570\u636e\u5904\u7406\u548c\u5206\u6790<\/span><\/h1>\n

\uff08\u4e00\uff09\u6570\u636e\u96c6<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u7528\u4e8e\u7edf\u8ba1\u5206\u6790\u7684\u6570\u636e\u96c6\u4e8b\u5148\u9700\u8981\u5728\u65b9\u6848\u4e2d\u660e\u786e\u5b9a\u4e49\uff0c\u5305\u62ec\u5177\u4f53\u7684\u53d7\u8bd5\u8005\u6392\u9664\u6807\u51c6\u3002\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c<\/span>BE<\/span>\u7814\u7a76\u7684\u5206\u6790\u6570\u636e\u96c6\u5e94\u81f3\u5c11\u5305\u62ec\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u96c6\uff08<\/span>Pharmacokinetics Concentration Set<\/span>\uff0c<\/span>PKCS<\/span>\uff09\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6\uff08<\/span>Pharmacokinetics Parameter Set<\/span>\uff0c<\/span>PKPS<\/span>\uff09\u3001\u751f\u7269\u7b49\u6548\u6027\u96c6\uff08<\/span>Bioequivalence Set<\/span>\uff0c<\/span>BES<\/span>\uff09\u3001\u5b89\u5168\u96c6\uff08<\/span>Safety Set<\/span>\uff0c\u7b80\u79f0<\/span>SS<\/span>\uff09\u3002<\/span><\/span><\/p>\n

\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u96c6\uff08<\/span>PKCS<\/span>\uff09\uff1a\u5305\u62ec\u6240\u6709\u968f\u673a\u5316\uff0c\u4e14\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u7814\u7a76\u836f\u7269\uff0c\u5e76\u6709\u81f3\u5c11\u4e00\u4e2a\u7528\u836f\u540e\u6709\u6548\u7684\u68c0\u6d4b\u6210\u5206\u6d53\u5ea6\u6570\u636e\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u4e3a\u63cf\u8ff0\u6027\u7edf\u8ba1\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u6570\u636e\u3002<\/span><\/span><\/p>\n

\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6\uff08<\/span>PKPS<\/span>\uff09\uff1a\u5305\u62ec\u6240\u6709\u968f\u673a\u5316\uff0c\u4e14\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u7814\u7a76\u836f\u7269\uff0c\u5e76\u6709\u81f3\u5c11\u4e00\u4e2a\u6709\u6548\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u5728\u4e8e\u63cf\u8ff0\u6027\u7edf\u8ba1\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u3002<\/span><\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u96c6\uff08<\/span>BES<\/span>\uff09\uff1a\u5305\u62ec\u5b8c\u6210\u6240\u6709\u5468\u671f\u8bd5\u9a8c\u5e76\u63d0\u4f9b\u5b8c\u6574\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u6570\u636e\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u662f\u63a8\u65ad\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u662f\u5426\u7b49\u6548\u7684\u4e3b\u8981\u6570\u636e\u96c6\u3002\u672c\u6570\u636e\u96c6\u5e94\u9488\u5bf9\u4e0d\u540c\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u8bbe\u5b9a\uff0c\u4f8b\u5982\u7814\u7a76\u9488\u5bf9<\/span>Cmax<\/sub><\/span>\u3001<\/span>AUC0-t<\/sub><\/span>\u548c<\/span>AUC0-<\/sub><\/span>\u221e<\/span><\/sub>\u4e09\u4e2a\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u8fdb\u884c\u5206\u6790\uff0c\u5219\u672c\u7814\u7a76\u5e94\u5305\u542b\u4e09\u4e2a<\/span>BES<\/span>\u3002<\/span><\/span><\/p>\n

\u5b89\u5168\u96c6\uff08<\/span>SS<\/span>\uff09\uff1a\u5305\u62ec\u6240\u6709\u968f\u673a\u5316\u540e\u81f3\u5c11\u63a5\u53d7\u4e00\u6b21\u7814\u7a76\u836f\u7269\u4e14\u6709\u5b89\u5168\u6027\u8bc4\u4ef7\u7684\u53d7\u8bd5\u8005\u3002\u672c\u6570\u636e\u96c6\u7684\u4f5c\u7528\u5728\u4e8e\u5206\u6790\u8bd5\u9a8c\u7684\u5b89\u5168\u6027\u3002<\/span><\/span><\/p>\n

\uff08\u4e8c\uff09\u6570\u636e\u8f6c\u6362<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5efa\u8bae\u5bf9\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\uff08\u5982<\/span>AUC<\/span>\u548c<\/span>Cmax<\/sub><\/span>\uff09\u4f7f\u7528\u81ea\u7136\u5bf9\u6570\u8fdb\u884c\u6570\u636e\u8f6c\u6362\u3002\u9009\u62e9\u7684\u5bf9\u6570\u8f6c\u6362\u65b9\u5f0f\u5e94\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u4fdd\u6301\u4e00\u81f4\uff0c\u4e14\u9700\u5728\u65b9\u6848\u4e2d\u6307\u660e\u3002\u5728\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\uff0c\u7531\u4e8e\u6837\u672c\u91cf\u8f83\u5c11\uff0c\u96be\u4ee5\u786e\u5b9a\u6570\u636e\u7684\u5206\u5e03\u3002\u56e0\u6b64\uff0c\u4e0d\u5efa\u8bae\u4ee5\u5bf9\u6570\u8f6c\u6362\u540e\u6570\u636e\u4e0d\u670d\u4ece\u6b63\u6001\u5206\u5e03\uff0c\u6216\u539f\u59cb\u6570\u636e\u670d\u4ece\u6b63\u6001\u5206\u5e03\u4e3a\u7531\uff0c\u800c\u4f7f\u7528\u539f\u59cb\u6570\u636e\u8fdb\u884c\u7edf\u8ba1\u5206\u6790\u3002<\/span><\/span><\/p>\n

\uff08\u4e09\uff09\u7edf\u8ba1\u5047\u8bbe\u4e0e\u63a8\u65ad<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e73\u5747\u751f\u7269\u7b49\u6548\u8981\u6c42\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u5dee\u5f02\u5728\u4e00\u5b9a\u53ef\u63a5\u53d7\u8303\u56f4\u5185\uff0c\u901a\u8fc7\u4ee5\u4e0b\u5047\u8bbe\u68c0\u9a8c\u6765\u8fdb\u884c\u7edf\u8ba1\u63a8\u65ad\u3002<\/span><\/p>\n

\u539f\u5047\u8bbe<\/span>H<\/span><\/em>0<\/span><\/sub>\uff1a<\/span>                             <\/span><\/span><\/p>\n

\u5907\u62e9\u5047\u8bbe<\/span>H<\/span><\/em>1<\/span><\/sub>\uff1a<\/span><\/span><\/span><\/p>\n

\u5176\u4e2d<\/span>\u03bcT<\/sub><\/span><\/em>\u4e3a\u53d7\u8bd5\u5236\u5242\u5bf9\u6570\u53d8\u6362\u540e\u836f\u4ee3\u53c2\u6570\u603b\u4f53\u5747\u6570\uff0c<\/span>\u03bcR<\/sub><\/span><\/em>\u4e3a\u53c2\u6bd4\u5236\u5242\u5bf9\u6570\u53d8\u6362\u540e\u836f\u4ee3\u53c2\u6570\u603b\u4f53\u5747\u6570\uff0c\u03b8<\/em>\u4e3a\u751f\u7269\u7b49\u6548\u6027\u754c\u503c\u3002\u5728\u8bbe\u5b9a\u7684\u68c0\u9a8c\u6c34\u51c6\u4e0b\uff0c\u82e5\u62d2\u7edd\u539f\u5047\u8bbe<\/span>H<\/span><\/em>0<\/span><\/sub>\uff0c\u5219\u8868\u660e\u751f\u7269\u7b49\u6548\u3002\u4e00\u822c\u79f0<\/span><\/span>\u4e3a\u5e73\u5747\u751f\u7269\u7b49\u6548\u6807\u51c6\uff0c\u8be5\u6807\u51c6\u7b49\u4ef7\u4e8e<\/span>–\u03b8<\/em><\/span>\u2264\u03bc<\/span><\/em>T<\/span><\/sub><\/em>–<\/span><\/em>\u03bc<\/span><\/em>R<\/span><\/sub><\/em>\u2264<\/span><\/em>\u03b8<\/span><\/em>\u3002\u901a\u5e38\u8bbe\u5b9a<\/span>\u03b8<\/span><\/em>=ln(1.25)<\/span>\uff0c<\/span>–\u03b8<\/em>=ln(0.8)<\/span>\u3002\u8be5\u6807\u51c6\u540c\u65f6\u9002\u7528\u4e8e<\/span>Cmax<\/sub><\/span>\u548c<\/span>AUC<\/span>\u3002<\/span><\/span><\/p>\n

\u5bf9<\/span>Tmax<\/sub><\/span>\u7684\u5206\u6790\u901a\u5e38\u91c7\u7528\u975e\u53c2\u6570\u65b9\u6cd5\u8fdb\u884c\u5dee\u5f02\u6027\u68c0\u9a8c\u3002<\/span><\/span><\/p>\n

\uff08\u56db\uff09\u6570\u636e\u5206\u6790<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

1.<\/span>\u6982\u8ff0<\/span><\/span><\/p>\n

\u5bf9\u4e8e\u4e0a\u6587\u63d0\u5230\u7684\u751f\u7269\u7b49\u6548\u6027\u6807\u51c6\uff0c\u901a\u5e38\u662f\u6784\u5efa\u03bc<\/em><\/span>T<\/span><\/sub><\/em>–<\/span>\u03bc<\/span><\/em>R<\/span><\/sub><\/em>\u7684\u53cc\u4fa7<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\uff0c\u82e5\u6b64\u7f6e\u4fe1\u533a\u95f4\u843d\u5728\u533a\u95f4<\/span><\/span>\u5185\uff0c\u5219\u53ef\u63a8\u65ad\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u6ee1\u8db3\u751f\u7269\u7b49\u6548\u3002\u6b64\u65b9\u6cd5\u7b49\u4ef7\u4e8e\u5728<\/span>0.05<\/span>\u7684\u68c0\u9a8c\u6c34\u51c6\u4e0b\u8fdb\u884c\u53cc\u5355\u4fa7\u5047\u8bbe\u68c0\u9a8c\u3002\u5e94\u6839\u636e\u4e0d\u540c\u7684\u8bd5\u9a8c\u8bbe\u8ba1\u9009\u62e9\u6070\u5f53\u7684\u7f6e\u4fe1\u533a\u95f4\u8ba1\u7b97\u65b9\u6cd5\u3002\u8ba1\u7b97\u51fa\u03bc<\/em><\/span>T<\/span><\/sub><\/em>–<\/span>\u03bc<\/span><\/em>R<\/span><\/sub><\/em>\u7684\u53cc\u4fa7<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u540e\uff0c\u53ef\u901a\u8fc7\u9006\u5bf9\u6570\u53d8\u6362\uff08\u6307\u6570\u53d8\u6362\uff09\u5f97\u5230\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u539f\u59cb\u6570\u636e\u7684<\/span>GMR<\/span>\u7684\u53cc\u4fa7<\/span>90%<\/span>\u7f6e\u4fe1\u533a\u95f4\u3002<\/span><\/span><\/p>\n

2.<\/span>\u4ea4\u53c9\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5bf9\u4e8e\u4ea4\u53c9\u8bbe\u8ba1\uff0c\u5efa\u8bae\u4f7f\u7528\u7ebf\u6027\u6df7\u5408\u6548\u5e94\u6a21\u578b\u8fdb\u884c\u5206\u6790\u8ba1\u7b97\u3002<\/span><\/p>\n

3.<\/span>\u5e73\u884c\u7ec4\u8bbe\u8ba1<\/span><\/span><\/p>\n

\u5efa\u8bae\u91c7\u7528\u57fa\u4e8e\u6b63\u6001\u5206\u5e03\u5747\u6570\u5dee\u503c\u7684\u7f6e\u4fe1\u533a\u95f4\u6784\u5efa\u65b9\u6cd5\u3002<\/span><\/p>\n

\uff08\u4e94\uff09\u79bb\u7fa4\u6570\u636e\u5904\u7406<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

BE<\/span>\u7814\u7a76\u4e2d\u901a\u5e38\u4e0d\u5efa\u8bae\u5254\u9664\u79bb\u7fa4\u503c\u3002<\/span><\/span><\/p>\n

\u5fc5\u8981\u65f6\u9700\u8981\u9488\u5bf9\u79bb\u7fa4\u503c\u8fdb\u884c\u654f\u611f\u6027\u5206\u6790\uff0c\u5373\u8bc4\u4ef7\u5254\u9664\u548c\u4e0d\u5254\u9664\u79bb\u7fa4\u503c\u5bf9\u751f\u7269\u7b49\u6548\u6027\u7ed3\u679c\u7684\u5f71\u54cd\u3002\u5982\u679c\u7ed3\u8bba\u4e0d\u4e00\u81f4\uff0c\u9700\u89e3\u91ca\u8bf4\u660e\u5e76\u5206\u6790\u539f\u56e0\u3002<\/span><\/p>\n

\uff08\u516d\uff09\u5176\u4ed6\u95ee\u9898<\/span><\/strong><\/span><\/p>\n

\u5982\u679c\u4e00\u4e2a\u4ea4\u53c9\u8bbe\u8ba1\u662f\u5728\u4e24\u4e2a\u53ca\u4ee5\u4e0a\u7684\u4e2d\u5fc3\u8fdb\u884c\uff0c\u7edf\u8ba1\u6a21\u578b\u4e2d\u5e94\u8be5\u8003\u8651\u4e2d\u5fc3\u6548\u5e94\u3002\u6240\u7528\u6a21\u578b\u5e94\u8be5\u80fd\u4f30\u8ba1\u4e0d\u540c\u4e2d\u5fc3\u7684\u6548\u5e94\uff0c\u53cd\u6620\u4e0d\u540c\u4e2d\u5fc3\u7684\u5b9e\u9645\u60c5\u51b5\uff0c\u5e76\u8bf4\u660e\u6765\u81ea\u4e0d\u540c\u4e2d\u5fc3\u7684\u8bd5\u9a8c\u6570\u636e\u662f\u5426\u53ef\u4ee5\u5408\u5e76\u8fdb\u884c\u5206\u6790\u3002<\/span><\/p>\n

\u5982\u679c\u5b58\u5728\u591a\u79cd\u53d7\u8bd5\u5236\u5242\u548c<\/span>\/<\/span>\u6216\u591a\u79cd\u53c2\u6bd4\u5236\u5242\uff0c\u901a\u5e38\u4f1a\u6709\u591a\u4e2a\u751f\u7269\u7b49\u6548\u7684\u5047\u8bbe\u68c0\u9a8c\u3002\u82e5\u8bd5\u9a8c\u8981\u6c42\u8fbe\u5230\u5168\u90e8\u751f\u7269\u7b49\u6548\uff0c\u5219\u65e0\u9700\u8fdb\u884c<\/span>I<\/span>\u7c7b\u9519\u8bef\u7684\u8c03\u6574\uff1b\u82e5\u8bd5\u9a8c\u4e0d\u8981\u6c42\u8fbe\u5230\u5168\u90e8\u751f\u7269\u7b49\u6548\uff0c\u5219\u9700\u5bf9<\/span>I<\/span>\u7c7b\u9519\u8bef\u8fdb\u884c\u8c03\u6574\uff0c\u8c03\u6574\u7684\u65b9\u6cd5\u6709<\/span>Bonferroni<\/span>\u6cd5\u3001<\/span>Hochberg<\/span>\u6cd5\u7b49\u3002<\/span><\/span><\/p>\n

\u56db\u3001  <\/span>\u7ed3\u679c\u62a5\u544a<\/span><\/h1>\n

\u7ed3\u679c\u62a5\u544a\u4e2d\u5e94\u5bf9\u4ee5\u4e0b\u5185\u5bb9\u8fdb\u884c\u8be6\u7ec6\u8bf4\u660e\u3002<\/span><\/p>\n

\uff08\u4e00\uff09\u968f\u673a\u5316<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e94\u5177\u4f53\u8bf4\u660e\u8bd5\u9a8c\u7528\u7684\u968f\u673a\u5316\u7cfb\u7edf\u548c\u968f\u673a\u5316\u65b9\u6848\uff0c\u5305\u62ec\u968f\u673a\u5316\u63a7\u5236\u7684\u56e0\u7d20\u3001\u533a\u7ec4\u3001\u79cd\u5b50\u6570\u7b49\uff0c\u5e76\u9644\u6709\u968f\u673a\u5316\u6570\u5b57\u8868\u3002<\/span><\/p>\n

\u968f\u673a\u5316\u7684\u7ed3\u679c\u5e94\u7528\u8868\u683c\u63cf\u8ff0\uff0c\u5176\u4e2d\u5305\u542b\u53d7\u8bd5\u8005\u7f16\u53f7\u3001\u6bcf\u4e00\u5468\u671f\u7684\u7528\u836f\u60c5\u51b5\uff0c\u4ee5\u53ca\u968f\u673a\u5316\u63a7\u5236\u7684\u56e0\u7d20\u7b49\u3002\u968f\u673a\u5316\u7ed3\u679c\u53ef\u5728\u9644\u5f55\u4e2d\u5c55\u73b0\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u7edf\u8ba1\u5b66\u65b9\u6cd5<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e94\u8bf4\u660e\u6240\u91c7\u7528\u7684\u7edf\u8ba1\u5b66\u65b9\u6cd5\uff0c\u5305\u62ec\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u8ba1\u7b97\u65b9\u6cd5\u3001\u5206\u6790\u6a21\u578b\u548c\u7b49\u6548\u6027\u68c0\u9a8c\u65b9\u6cd5\u3001\u5bf9\u6570\u8f6c\u6362\u7b49\u5185\u5bb9\u3002\u8fd8\u9700\u8bf4\u660e\u4f7f\u7528\u8f6f\u4ef6\u7684\u540d\u79f0\u4e0e\u7248\u672c\u53f7\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u7edf\u8ba1\u5206\u6790\u7ed3\u679c<\/span><\/strong><\/span><\/strong><\/span><\/p>\n

\u5e94\u63d0\u4f9b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7ed9\u836f\u540e\u7684\u68c0\u6d4b\u6210\u5206\u6d53\u5ea6\u68c0\u6d4b\u7ed3\u679c\uff0c\u4f7f\u7528\u539f\u59cb\u6570\u636e\u5c55\u73b0\u3002\u5728\u9644\u5f55\u4e2d\u5e94\u540c\u65f6\u7ed9\u51fa\u7b97\u6570\u5750\u6807\u4ee5\u53ca\u5bf9\u6570\u5750\u6807\u4e0b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7ed9\u836f\u540e\u7684\u836f\u65f6\u66f2\u7ebf\u3001\u4e0d\u540c\u836f\u7269\u5236\u5242\u7684\u5e73\u5747\u836f\u65f6\u66f2\u7ebf\u3002<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7ed3\u679c\uff0c\u4e5f\u5e94\u4f7f\u7528\u539f\u59cb\u6570\u636e\u5c55\u73b0\u3002\u5bf9\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u63cf\u8ff0\u5e94\u5305\u62ec\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u7b97\u672f\u5747\u503c\u3001\u51e0\u4f55\u5747\u503c\u3001\u6807\u51c6\u5dee\u548c\u53d8\u5f02\u7cfb\u6570\u3002<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u5305\u542b\u5e8f\u5217\u5185\u5d4c\u5957\u53d7\u8bd5\u8005\u3001\u5e8f\u5217\u3001\u5468\u671f\u548c\u5236\u5242\u56e0\u7d20\u7684\u6df7\u5408\u6548\u5e94\u6a21\u578b\u7ed3\u679c\u3002\u82e5\u5b58\u5728\u5176\u4ed6\u8fd8\u9700\u8003\u8651\u7684\u56e0\u7d20\uff0c\u4e5f\u5e94\u5305\u542b\u5728\u6a21\u578b\u4e2d\u3002<\/span><\/p>\n

\u5e94\u63d0\u4f9b\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u51e0\u4f55\u5747\u503c\u6bd4\u53ca\u5176\u7f6e\u4fe1\u533a\u95f4\u4f30\u8ba1\u7ed3\u679c\u3002<\/span><\/p>\n

\u4e94\u3001  <\/span>\u6570\u636e\u7ba1\u7406<\/span><\/h1>\n

\u4ee5\u6ce8\u518c\u4e0a\u5e02\u4e3a\u76ee\u7684\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u6570\u636e\u7ba1\u7406\u8981\u6c42\u5e94\u4e0e\u4e00\u822c\u4e34\u5e8a\u8bd5\u9a8c\u76f8\u540c\uff0c\u53ef\u53c2\u8003\u300a\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u5de5\u4f5c\u6280\u672f\u6307\u5357\u300b\u3002<\/span><\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\u751f\u7269\u6837\u672c\u5206\u6790\u7b49\u6570\u636e\u4e3a\u5916\u90e8\u6570\u636e\uff0c\u5728\u68c0\u6d4b\u548c\u4f20\u8f93\u8fc7\u7a0b\u4e2d\u5e94\u4fdd\u6301\u76f2\u6001\u5e76\u6309\u7167\u63d0\u524d\u5236\u5b9a\u7684\u4f20\u8f93\u534f\u8bae\u8fdb\u884c\u6570\u636e\u4f20\u8f93\u3002\u8bd5\u9a8c\u6d89\u53ca\u5230\u7684\u751f\u7269\u6837\u672c\u68c0\u6d4b\u3001\u4e34\u5e8a\u6570\u636e\u4f20\u8f93\u548c\u7edf\u8ba1\u5206\u6790\u76f8\u5173\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u5e94\u7ecf\u8fc7\u9a8c\u8bc1\u5e76\u4fdd\u6301\u9a8c\u8bc1\u72b6\u6001\u3002<\/span><\/p>\n

\u516d\u3001  <\/span>\u672f\u8bed\u8868<\/span><\/h1>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u82f1\u6587\u5168\u79f0<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u82f1\u6587\u7f29\u5199<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u4e2d\u6587\u5168\u79f0<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n<\/thead>\n

\n

Bioequivalence<\/span><\/p>\n<\/td>\n

\n

BE<\/span><\/p>\n<\/td>\n

\n

\u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Average Bioequivalence<\/span><\/p>\n<\/td>\n

\n

ABE<\/span><\/p>\n<\/td>\n

\n

\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Population Bioequivalence<\/span><\/p>\n<\/td>\n

\n

PBE<\/span><\/p>\n<\/td>\n

\n

\u7fa4\u4f53\u751f\u7269\u7b49\u6548\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Geometric mean ratio<\/span><\/p>\n<\/td>\n

\n

GMR<\/span><\/p>\n<\/td>\n

\n

\u51e0\u4f55\u5747\u503c\u6bd4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Intra-subject coefficient of variation<\/span><\/p>\n<\/td>\n

\n

CV%<\/span><\/p>\n<\/td>\n

\n

\u4e2a\u4f53\u5185\u53d8\u5f02<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Bioequivalence Set<\/span><\/p>\n<\/td>\n

\n

BES<\/span><\/p>\n<\/td>\n

\n

\u751f\u7269\u7b49\u6548\u6027\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pharmacokinetics Concentration Set<\/span><\/p>\n<\/td>\n

\n

PKCS<\/span><\/p>\n<\/td>\n

\n

\u836f\u4ee3\u52a8\u529b\u5b66\u6d53\u5ea6\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pharmacokinetics Parameter Set<\/span><\/p>\n<\/td>\n

\n

PKPS<\/span><\/p>\n<\/td>\n

\n

\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Safety Set<\/span><\/p>\n<\/td>\n

\n

SS<\/span><\/p>\n<\/td>\n

\n

\u5b89\u5168\u96c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Subject nested in sequence<\/span><\/p>\n<\/td>\n

\n

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

\n

\u5e8f\u5217\u5185\u5d4c\u5957\u53d7\u8bd5\u8005<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

\"CDE\uff1a\u300a\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u548c\u300a\u9ad8\u53d8\u5f02\u836f\u7269\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\u3002\"<\/p>\n<\/p>\n

\u672c\u671f\u7f16\u8f91\uff1a\u6211\u7231\u5403\u6787\u6777\u3002<\/span><\/p>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u54c1\u5708 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u9644\u4ef61\uff1a         \u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u7edf\u8ba1\u5b66\u6307\u5bfc\u539f\u5219 & […]<\/p>\n","protected":false},"author":1,"featured_media":10931,"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\/10930"}],"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=10930"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/10930\/revisions"}],"predecessor-version":[{"id":10935,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/10930\/revisions\/10935"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/10931"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=10930"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=10930"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=10930"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}