{"id":85656,"date":"2019-04-16T00:00:50","date_gmt":"2019-04-18T07:51:21","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/85656\/"},"modified":"2019-04-18T15:51:22","modified_gmt":"2019-04-18T07:51:22","slug":"202fd4c3a1","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/85656\/","title":{"rendered":"FDA\u5173\u4e8e\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u548c\u8bf4\u660e\u4e66\u5efa\u8bae\u7684\u6307\u5bfc\u539f\u5219\uff08\u8349\u6848\uff09"},"content":{"rendered":"
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\u70b9\u51fb\u4e0a\u65b9\u7684<\/span>  \u25b2<\/span> \u6dfb\u52a0\u5173\u6ce8<\/span><\/span><\/p>\n


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FDA\u4e8e2017\u5e749\u670828\u65e5\u53d1\u5e03\u4e86\u5173\u4e8e\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u548c\u8bf4\u660e\u4e66\u8981\u6c42\u7684\u5de5\u4e1a\u5316\u6280\u672f\u6307\u5357\u5f81\u6c42\u610f\u89c1\u7a3f\uff0c\u8bf7\u793e\u4f1a\u516c\u4f17\u572860\u5929\u5185\u63d0\u51fa\u4fee\u8ba2\u5efa\u8bae\u3002\u6211\u56fd\u76ee\u524d\u4e5f\u6709\u5927\u91cf\u6297\u80bf\u7624\u65b0\u836f\u5728\u6ce8\u518c\u7533\u8bf7\uff0c\u4e5f\u9762\u4e34\u7740\u540c\u6837\u7684\u6280\u672f\u95ee\u9898\u3002\u4e3a\u6b64\uff0c\u836f\u7406\u6bd2\u7406\u5b66\u90e8\u6df1\u5165\u5b66\u4e60\u4e86\u8be5\u6307\u5357\u5185\u5bb9\uff0c\u5e76\u6574\u7406\u4e86\u8be5\u6307\u5357\u7684\u4e2d\u6587\u7ffb\u8bd1\u7a3f\u3002\u540e\u7eed\u6211\u4eec\u5c06\u8fdb\u4e00\u6b65\u8ddf\u8e2a\u56fd\u5916\u76f8\u5173\u6280\u672f\u8981\u6c42\u8fdb\u5c55\uff0c\u6c47\u603b\u56fd\u5185\u6297\u80bf\u7624\u836f\u7269\u4e0a\u5e02\u7533\u8bf7\u4e2d\u7684\u751f\u6b96\u6bd2\u6027\u652f\u6301\u6570\u636e\u4fe1\u606f\uff0c\u5e76\u5f81\u6c42\u56fd\u5185\u884c\u4e1a\u7684\u610f\u89c1\u548c\u5efa\u8bae\uff0c\u660e\u786e\u6211\u56fd\u6297\u80bf\u7624\u836f\u7269\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u7684\u751f\u6b96\u6bd2\u6027\u98ce\u9669\u8bc4\u4ef7\u8981\u6c42\u3002
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1  \u7b80\u4ecb<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

       \u672c\u6307\u5bfc\u539f\u5219\u7684\u76ee\u7684\u662f\u5e2e\u52a9\u7533\u8bf7\u4eba\u8fdb\u884c\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96\u6bd2\u6027\u8bc4\u4f30[\u4e3b\u8981\u662f\u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u6bd2\u6027\uff08EFD\uff09]\uff0c\u5e76\u63a8\u8350\u5728\u8bf4\u660e\u4e66\u4e2d\u6807\u6ce8\u505c\u6b62\u6cbb\u7597\u540e\u7684\u907f\u5b55\u65f6\u95f4\uff0c\u4f7f\u5bf9\u80da\u80ce\/\u80ce\u513f\u53d1\u80b2\u7684\u6f5c\u5728\u98ce\u9669\u6700\u5c0f\u5316\u3002\u672c\u6307\u5bfc\u539f\u5219\u5c06\u5728\u4ee5\u4e0b\u65b9\u9762\u8fdb\u884c\u8ba8\u8bba\u3002
  \u25cf \u5404\u7c7b\u836f\u7269\u7684EFD\u6bd2\u6027\u8bc4\u4ef7\uff0c\u4ee5\u53ca\u4f55\u65f6\u4e0d\u9700\u8981\u8fdb\u884c\u8fd9\u4e9b\u8bd5\u9a8c\u3002
  \u25cf \u9488\u5bf9\u7279\u5b9a\u4eba\u7fa4\u836f\u7269\u7684EFD\u6bd2\u6027\u8bc4\u4ef7\u3002
  \u25cf \u4f7f\u7528\u975e\u4e34\u5e8a\u4fe1\u606f\uff08\u5982\u9057\u4f20\u6bd2\u6027\u548c\u4e00\u822c\u6bd2\u6027\u8bd5\u9a8c\u7684\u7ed3\u679c\uff09\uff0c\u8bc4\u4f30\u8fdb\u884c\u4e13\u95e8\u7684EFD\u8bd5\u9a8c\u7684\u7684\u5fc5\u8981\u6027\u3002
  \u25cf \u8bf4\u660e\u4e66\u4e2d\u5173\u4e8eEFD\u8bd5\u9a8c\u548c\u4eba\u4f53\u53d1\u80b2\u4e0d\u826f\u7ed3\u679c\u6f5c\u5728\u98ce\u9669\uff08\u8bf4\u660e\u4e66\u4e2d\u598a\u5a20\u90e8\u5206\uff09\u7684\u5efa\u8bae\uff0c\u4ee5\u53ca\u5173\u4e8e\u60a3\u8005\u907f\u5b55\u4ee5\u6700\u5c0f\u5316\u80da\u80ce\/\u80ce\u513f\uff08\u8bf4\u660e\u4e66\u4e2d\u7537\u5973\u751f\u6b96\u6f5c\u529b\u90e8\u5206\uff09\u53d1\u80b2\u98ce\u9669\u7684\u5efa\u8bae\u3002
      \u672c\u6307\u5bfc\u539f\u5219\u7684\u836f\u7269\u662f\u6307\u5c0f\u5206\u5b50\u3001\u6cbb\u7597\u6027\u86cb\u767d\u3001\u6297\u4f53\u548c\u76f8\u5173\u5236\u54c1\u5982\u5076\u8054\u4ea7\u54c1\u3002\u672c\u6307\u5bfc\u539f\u5219\u4e0d\u9610\u8ff0\u751f\u7269\u7c7b\u4f3c\u836f\u3001\u53ef\u4e92\u6362\u836f\u7269\u3001\u653e\u5c04\u6027\u836f\u7269\u3001\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u3001\u764c\u75c7\u75ab\u82d7\u7684\u98ce\u9669\u3002\u672f\u8bed\u201c\u81f4\u7578\u6027\u201d\u662f\u6307\u5bf9\u6b63\u5e38\u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u7684\u5e72\u6270\u4ece\u800c\u53ef\u80fd\u5bfc\u81f4\u7578\u5f62\u548c\u6b7b\u4ea1\u7684\u4e8b\u4ef6\u3002\u7136\u800c\uff0c\u67d0\u4e9b\u7c7b\u578b\u836f\u7269\uff08\u4f8b\u5982\u80bf\u7624\u514d\u75ab\uff09\u7684\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\u53ef\u80fd\u4e0d\u662f\u7531\u4e8e\u836f\u7269\u5bf9\u80ce\u4ed4\u7684\u76f4\u63a5\u4f5c\u7528\u6240\u81f4\uff0c\u800c\u662f\u7531\u4e8e\u514d\u75ab\u6392\u65a5\uff0c\u5e76\u4e0d\u5177\u6709\u660e\u663e\u7684\u81f4\u7578\u6027\u3002\u56e0\u6b64\uff0c\u672c\u6307\u5bfc\u539f\u5219\u4e2d\u7684\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\u5305\u62ec\u6240\u6709\u539f\u56e0\u5f15\u8d77\u7684\u6b7b\u4ea1\uff0c\u4e0d\u7ba1\u662f\u5426\u5b58\u5728\u7578\u5f62\u3002
      \u672c\u6307\u5bfc\u539f\u5219\u4e0d\u6d89\u53ca\u66b4\u9732\u91cf\u6216\u5242\u91cf\u7684\u5b89\u5168\u8303\u56f4\u3002\u5f88\u591a\u6297\u80bf\u7624\u836f\u7269\u7279\u522b\u662f\u672c\u6307\u5bfc\u539f\u5219\u6240\u6d89\u53ca\u7684\u5c0f\u5206\u5b50\u836f\u7269\uff0c\u672a\u786e\u5b9a\u5b89\u5168\u5242\u91cf\u8303\u56f4\uff08\u5373\u5728\u4e0e\u4eba\u4f53\u63a8\u8350\u5242\u91cf\u76f8\u5f53\u6216\u4f4e\u4e8e\u4eba\u4f53\u63a8\u8350\u5242\u91cf\u7684\u66b4\u9732\u65f6\uff0c\u5728\u52a8\u7269\u4e2d\u89c2\u5bdf\u5230\u80da\u80ce-\u80ce\u4ed4\u6bd2\u6027\uff09\u3002\u80da\u80ce-\u80ce\u513f\u7684\u53d1\u80b2\u98ce\u9669\u662f\u5728\u60a3\u8005\u4e2d\u4e3b\u8981\u62c5\u5fe7\u7684\u95ee\u9898\uff0c\u4e5f\u662f\u8fdb\u884cEFD\u8bd5\u9a8c\u7684\u539f\u56e0\uff0c\u4ee5\u4fbf\u53ef\u80fd\u5728\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u5305\u62ec\u5173\u4e8e\u907f\u5b55\u7684\u5408\u9002\u5efa\u8bae\u3002\u7136\u800c\uff0c\u672c\u6307\u5bfc\u539f\u5219\u4e0d\u6d89\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u80da\u80ce-\u80ce\u513f\u7684\u6f5c\u5728\u98ce\u9669\uff0c\u56e0\u4e3a\u76f8\u5173\u7684\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u9700\u8981\u91c7\u53d6\u8db3\u591f\u7684\u907f\u5b55\u63aa\u65bd\u3002\u867d\u7136\u5bf9\u4e8e\u665a\u671f\u80bf\u7624\u9002\u5e94\u75c7\u7684\u4e0a\u5e02\u7533\u8bf7\u4e00\u822c\u4e0d\u9700\u8981\u751f\u80b2\u529b\u8bd5\u9a8c\u548c\u56f4\u4ea7\u671f\u8bd5\u9a8c\uff0c\u672c\u6307\u5bfc\u539f\u5219\u5305\u542b\u4e86\u5728\u975e\u665a\u671f\u80bf\u7624\u9002\u5e94\u75c7\u4e2d\u8ba8\u8bba\u4e86\u4ee5\u4e0a\u4e24\u65b9\u9762\u7684\u4e00\u4e9b\u5185\u5bb9\u3002
       \u672c\u6307\u5bfc\u539f\u5219\u662fICH S9\uff08\u6297\u80bf\u7624\u836f\u7269\u7684\u975e\u4e34\u5e8a\u8bc4\u4ef7\uff09\u7684\u8865\u5145\u3002ICH S5\uff08\u836f\u7269\u751f\u6b96\u6bd2\u6027\u548c\u96c4\u6027\u751f\u80b2\u529b\u6bd2\u6027\u68c0\u6d4b\uff09\u548cICH S6(R1)\uff08\u751f\u7269\u5236\u54c1\u7684\u4e34\u5e8a\u524d\u8bc4\u4ef7\uff09\u9610\u8ff0\u4e86\u751f\u6b96\u6bd2\u6027\u8bc4\u4ef7\u7684\u7279\u6b8a\u8bd5\u9a8c\u8bbe\u8ba1\u3002\u672c\u6307\u5bfc\u539f\u5219\u63d0\u4f9b\u4e86\u4e00\u4e9b\u76ee\u524dS9\u6ca1\u6709\u63cf\u8ff0\u7684\u548cS6\u4ec5\u7b80\u5355\u8ba8\u8bba\u7684\u66ff\u4ee3\u6027\u8bc4\u4ef7\u7684\u6848\u4f8b\u3002\u672c\u6307\u5bfc\u539f\u5219\u8fd8\u63d0\u4f9b\u4e86\u4e5f\u63d0\u4f9b\u4e86\u76ee\u524dS9\u672a\u6d89\u53ca\u7684\u5173\u4e8e\u836f\u7269\u6f5c\u5728\u751f\u6b96\u6bd2\u6027\u98ce\u9669\u548c\u907f\u5b55\u7684\u975e\u4e34\u5e8a\u5efa\u8bae\u3002
       \u4e00\u822c\u6765\u8bf4\uff0cFDA\u6307\u5bfc\u539f\u5219\u6587\u4ef6\u4e0d\u5177\u5907\u5f3a\u5236\u7684\u6cd5\u5f8b\u6548\u5e94\u3002\u6307\u5bfc\u539f\u5219\u4ee3\u8868\u76ee\u524dFDA\u5bf9\u4e8e\u8be5\u4e3b\u9898\u7684\u8003\u8651\uff0c\u5e94\u8be5\u88ab\u89c6\u4f5c\u4ec5\u4e3a\u5efa\u8bae\uff0c\u9664\u975e\u6ce8\u660e\u4e3a\u7279\u522b\u7684\u76d1\u7ba1\u6216\u6cd5\u89c4\u8981\u6c42\u3002\u76d1\u7ba1\u673a\u6784\u7684\u6307\u5bfc\u539f\u5219\u4e2d\u7684\u201c\u5e94\uff08should\uff09\u201d\u6307\u7684\u662f\u5efa\u8bae\u6216\u63a8\u8350\uff0c\u800c\u4e0d\u662f\u8981\u6c42\u3002
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2 \u80cc\u666f<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

        ICH S9\u63a8\u8350\u4e86\u6297\u80bf\u7624\u836f\u7269IND\u7533\u8bf7\u548c\u540e\u7eed\u5f00\u53d1\u7684\u975e\u4e34\u5e8a\u7814\u7a76\u6240\u9700\u7c7b\u578b\u548c\u65f6\u95f4\u5b89\u6392\u3002\u5bf9\u4e8eS9\u8303\u56f4\u7c7b\u7684\u836f\u7269\uff0c\u8be5\u6307\u5bfc\u539f\u5219\u5efa\u8bae\uff0c\u5728\u65b0\u836f\u7533\u8bf7\u4e0a\u5e02\uff08NDA\uff09\u6216\u65b0\u751f\u7269\u5236\u54c1\u7533\u8bf7\u4e0a\u5e02\u65f6\u63d0\u4ea4EFD\u8bd5\u9a8c\u7ed3\u679c\u3002
      \u6709\u4e9b\u60c5\u51b5\u53ef\u80fd\u4e0d\u9700\u8981EFD\u6bd2\u6027\u8bd5\u9a8c\u3002\u4f8b\u5982\uff0c\u5177\u6709\u9057\u4f20\u6bd2\u6027\u4e14\u4e00\u822c\u6bd2\u6027\u8bd5\u9a8c\u786e\u5b9a\u9776\u5411\u4e8e\u8fc5\u901f\u5206\u5316\u7ec6\u80de\u7684\u836f\u7269\uff08ICH S9\uff09\uff0c\u4e00\u822c\u8ba4\u4e3a\u53ef\u5f15\u8d77\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u6b7b\u4ea1\u3002\u5728\u53e6\u5916\u4e00\u4e9b\u60c5\u51b5\u4e0b\uff0c\u4f5c\u4e3aEFD\u8bd5\u9a8c\u7684\u66ff\u4ee3\uff0c\u53ef\u63d0\u4f9b\u66ff\u4ee3\u6027\u7684\u98ce\u9669\u8bc4\u4f30\u3002\u81eaICH S9\u53d1\u5e03\u4ee5\u6765\uff0cFDA\u5df2\u7ecf\u83b7\u5f97\u4e86\u6297\u80bf\u7624\u836f\u7269\u66ff\u4ee3\u52a8\u7269\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u8fdb\u884c\u751f\u6b96\u6bd2\u6027\u8bc4\u4f30\u7684\u66ff\u4ee3\u65b9\u6cd5\u7684\u7ecf\u9a8c\u3002
       \u76ee\u524dICH\u6216FDA\u6307\u5bfc\u539f\u5219\u5bf9\u6297\u80bf\u7624\u836f\u7269\u6ca1\u6709\u5305\u62ec\u907f\u5b55\u7684\u5efa\u8bae\u3002\u7531\u4e8e\u6297\u80bf\u7624\u836f\u7269\u7684\u6bd2\u6027\u7279\u70b9\uff0c\u6709\u5fc5\u8981\u91c7\u7528\u907f\u5b55\u63aa\u65bd\u6765\u6700\u5c0f\u5316\u53d1\u80b2\u4e2d\u80da\u80ce\u66b4\u9732\u98ce\u9669\u3002
     <\/span><\/p>\n

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3 \u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u6bd2\u6027\u8bc4\u4ef7<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

3.1 \u4e00\u822c\u5efa\u8bae
      \u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u5f53\u91cd\u70b9\u62c5\u5fe7\u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u6bd2\u6027\u65f6\uff0c\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u5e94\u9075\u5faaICH S9\u7684\u5efa\u8bae\u3002EFD\u8bd5\u9a8c\u5e94\u8be5\u5728\u4e24\u4e2a\u52a8\u7269\u79cd\u5c5e\u4e2d\u8fdb\u884c\uff0c\u4e00\u822c\u4e3a\u5927\u9f20\uff08\u6216\u5c0f\u9f20\uff09\u548c\u5154\uff0c\u9664\u975e\u5728\u4e00\u4e2a\u52a8\u7269\u79cd\u5c5e\u4e2d\u5177\u6709\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u6b7b\u4ea1\u4e3a\u9633\u6027\uff0c\u8fd9\u65f6\u53ef\u80fd\u4e0d\u9700\u8981\u8fdb\u884c\u7b2c\u4e8c\u4e2a\u79cd\u5c5e\u8bd5\u9a8c\u3002\u5728\u4e00\u4e9b\u60c5\u51b5\u4e0b\uff0c\u975eGLP\u521d\u6b65\u8bd5\u9a8c\u660e\u786e\u5730\u8868\u660e\u5b58\u5728\u80da\u80ce-\u80ce\u4ed4\u6b7b\u4ea1\u6216\u81f4\u7578\u98ce\u9669\u65f6\uff0c\u53ef\u80fd\u4e0d\u9700\u8981\u786e\u8bc1\u6027\u7684GLP\u8bd5\u9a8c\u3002
3.2 \u7ec6\u80de\u6bd2\u7c7b\u836f\u7269
      \u5177\u6709\u9057\u4f20\u6bd2\u6027\u4e14\u4e00\u822c\u6bd2\u6027\u8bd5\u9a8c\u786e\u5b9a\u9776\u5411\u4e8e\u8fc5\u901f\u5206\u5316\u7ec6\u80de\u7684\u836f\u7269\uff0c\u4e00\u822c\u8ba4\u4e3a\u5177\u6709\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\u3002\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0cEFD\u8bd5\u9a8c\u88ab\u8ba4\u4e3a\u662f\u4e0d\u5fc5\u8981\u7684\u3002\u5728\u786e\u5b9aEFD\u8bd5\u9a8c\u5fc5\u8981\u6027\u65f6\uff0c\u5fc5\u987b\u81f3\u5c11\u4e24\u79cd\u9057\u4f20\u6bd2\u6027\u8bd5\u9a8c\u7684\u7ed3\u679c\u4e3a\u9633\u6027\u624d\u80fd\u4f5c\u4e3a\u8be5\u836f\u7269\u5177\u6709\u9057\u4f20\u6bd2\u6027\u7684\u5224\u65ad\u3002
3.3 \u751f\u7269\u5236\u54c1
      \u53c2\u7167ICH S9\uff0c\u5e94\u5728\u4e00\u79cd\u836f\u7406\u5b66\u76f8\u5173\u52a8\u7269\u79cd\u5c5e\u4e2d\u8fdb\u884cEFD\u8bd5\u9a8c\u3002\u5f53\u836f\u7406\u5b66\u76f8\u5173\u79cd\u5c5e\u662f\u975e\u4eba\u7075\u957f\u7c7b\u65f6\uff0c\u5e94\u8003\u8651ICH S6(R1)\u6240\u63cf\u8ff0\u7684\u589e\u5f3a\u6027\u56f4\u4ea7\u671f\u6bd2\u6027\u8bd5\u9a8c\uff08ePPND\uff09\uff0c\u8bd5\u9a8c\u8bbe\u8ba1\u53c2\u8003ICH S6(R1)\u3002\u5f53\u5bf9\u4e8e\u8be5\u4e34\u5e8a\u5019\u9009\u7269\u6ca1\u6709\u836f\u7406\u5b66\u76f8\u5173\u52a8\u7269\u79cd\u5c5e\u65f6\uff0c\u53ef\u8003\u8651\u4f7f\u7528\u826f\u597d\u8868\u5f81\u548c\u751f\u7269\u76f8\u5173\u7684\u66ff\u4ee3\u4ea7\u54c1\uff08\u5982\u679c\u6709\uff09\u3002\u7136\u800c\uff0c\u4e00\u822c\u4e0d\u5fc5\u4ec5\u4e3a\u4e86EFD\u8bd5\u9a8c\u800c\u5355\u72ec\u5236\u5907\u66ff\u4ee3\u4ea7\u54c1\u3002
      \u5f53EFD\u8bd5\u9a8c\u4e0d\u5fc5\u8981\u65f6\uff0c\u5e94\u8be5\u5b8c\u6210\u66ff\u4ee3\u8bc4\u4f30\u3002\u8bc4\u4f30\u5e94\u5305\u62ec\u4ee5\u4e0b\u4fe1\u606f\u6216\u6570\u636e\uff1a
  \u25cf \u6587\u732e\u8bc4\u4f30\u3002\u8bc4\u4f30\u5e94\u5305\u62ec\u4ee5\u4e0b\u8d44\u6599\u548c\u4fe1\u606f\uff1a
  \u2014 \u63cf\u8ff0\u80da\u80ce-\u80ce\u4ed4\u4e2d\u7684\u9776\u70b9\u8868\u8fbe\u3002
  \u2014 \u63cf\u8ff0\u5206\u5b50\u9776\u70b9\u5728\u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u4e2d\u7684\u4f5c\u7528\u3002
  \u2014 \u5982\u679c\u53ef\u83b7\u5f97\uff0c\u5305\u62ec\u6765\u6e90\u4e8e\u57fa\u56e0\u6572\u9664\u3001\u8f6c\u57fa\u56e0\u52a8\u7269\u6216\u7a81\u53d8\u57fa\u56e0\u52a8\u7269\u7684\u6570\u636e\uff08\u5f53\u5408\u9002\u65f6\uff09\u3002
  \u2014 \u57fa\u4e8e\u524d\u9762\u5217\u51fa\u7684\u76ee\u6807\u9879\uff0c\u63cf\u8ff0\u53d7\u8bd5\u7269\u7684\u5f71\u54cd\uff0c\u5982\u598a\u5a20\u7684\u4e22\u5931\u6216\u5b50\u4ee3\u4e2d\u7684\u8868\u578b\u7279\u5f81\u3002
  \u25cf \u4f53\u5916\u7814\u7a76\u5982\u900f\u8fc7\u80ce\u76d8\u5c4f\u969c\u7684\u80fd\u529b\uff08\u5982\u679c\u672a\u77e5\uff09\u3001\u4e0e\u80da\u80ce-\u80ce\u4ed4\u7ec4\u7ec7\u7684\u4ea4\u53c9\u53cd\u5e94\u3002\u8bc4\u4f30\u5e94\u63cf\u8ff0\u7531\u4e8e\u9776\u7ed3\u5408\u800c\u5f15\u8d77\u7684\u5bf9\u53d1\u80b2\u7684\u6f5c\u5728\u5f71\u54cd\u3002
       \u867d\u7136\u672c\u90e8\u5206\u5185\u5bb9\u662f\u5bf9\u751f\u7269\u5236\u54c1\u800c\u8a00\uff0c\u4f46\u5408\u9002\u65f6\u4e5f\u9002\u7528\u4e8e\u5c0f\u5206\u5b50\u836f\u7269\u3002<\/span><\/p>\n

3.4 \u5076\u8054\u836f\u7269
       \u5bf9\u4e8e\u5305\u542b\u6709\u751f\u7269\u5236\u54c1\u90e8\u5206\u548c\u5c0f\u5206\u5b50\u90e8\u5206\u7684\u5076\u8054\u836f\u7269\uff0cEFD\u8bd5\u9a8c\u7684\u8bbe\u8ba1\u53d6\u51b3\u4e8e\u591a\u79cd\u56e0\u7d20\uff0c\u5982\u751f\u7269\u5236\u54c1\u90e8\u5206\u5bf9\u9776\u70b9\u7684\u7ed3\u5408\u3001\u5c0f\u5206\u5b50\u91ca\u653e\u7684\u53ef\u80fd\u3001\u5c0f\u5206\u5b50\u7684\u6027\u8d28\uff08\u4f8b\u5982\u4f5c\u7528\u673a\u5236\u548c\u7ec6\u80de\u6bd2\u6027\uff09\u3001\u5bf9\u6bd2\u6027\u6765\u6e90\u7684\u8ba4\u77e5\uff08\u6765\u6e90\u4e8e\u751f\u7269\u5236\u54c1\u90e8\u5206\u8fd8\u662f\u5c0f\u5206\u5b50\u90e8\u5206\uff09\u3002\u4f8b\u5982\u6297\u4f53\u5076\u8054\uff08ADC\uff09\u836f\u7269\uff0c\u5f53\u5c0f\u5206\u5b50\u90e8\u5206\u662f\u7ec6\u80de\u6bd2\u7c7b\u836f\u7269\uff08\u9057\u4f20\u6bd2\u6027\u548c\u9776\u5411\u4e8e\u8fc5\u901f\u5206\u5316\u7ec6\u80de\uff09\u65f6\uff0c\u4e0d\u9700\u8981\u8fdb\u884cEFD\u8bd5\u9a8c\uff08\u89c1\u7b2c3.2\u9879\u76ee\u90e8\u5206\uff09\u3002\u5f53ADC\u836f\u7269\u9700\u8981\u8fdb\u884cEFD\u8bd5\u9a8c\u65f6\uff0c\u5982\u679cADC\u836f\u7269\u7684\u6bd2\u6027\u6765\u81ea\u4e8e\u5c0f\u5206\u5b50\uff0c\u800c\u6297\u4f53\u90e8\u5206\u4e0d\u4e0e\u52a8\u7269\u79cd\u5c5e\u4e2d\u7684\u9776\u70b9\u7ed3\u5408\uff0c\u90a3\u4e48\u8be5EFD\u8bd5\u9a8c\u53ef\u4ee5\u7528\u5c0f\u5206\u5b50\u8fdb\u884c\u3002\u5f53\u5076\u8054\u836f\u7269\u751f\u7269\u5236\u54c1\u90e8\u5206\u4e0e\u52a8\u7269\u79cd\u5c5e\u4e2d\u7684\u9776\u70b9\u7ed3\u5408\u65f6\uff0c\u901a\u5e38\u63a8\u8350\u7528\u5076\u8054\u836f\u7269\u8fdb\u884c\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u3002
3.5 \u8054\u5408\u7528\u836f
       \u5f53\u4e24\u79cd\u836f\u7269\u9700\u8981\u8054\u5408\u5e94\u7528\uff08\u598221CFR 3.2\uff09\u65f6\uff08\u8be5\u4e24\u79cd\u836f\u7269\u5bf9\u4e8e\u8fbe\u5230\u62df\u5b9a\u5e94\u7528\u3001\u9002\u5e94\u75c7\u6216\u7597\u6548\u5747\u5fc5\u9700\uff09\uff0cEFD\u8bd5\u9a8c\u65f6\u4e5f\u8054\u5408\u5e94\u7528\u3002\u5982\u679c\u4e00\u79cd\u836f\u7269\u5df2\u7ecf\u6709EFD\u6570\u636e\uff0c\u4e14\u663e\u793a\u5177\u6709\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\u65f6\uff0c\u4e0d\u5fc5\u8981\u518d\u8fdb\u884c\u989d\u5916\u7684\u8054\u5408\u5e94\u7528\u7684EFD\u8bd5\u9a8c\u3002
3.6 \u8102\u8d28\u4f53\u4ea7\u54c1
       \u901a\u5e38\u8102\u8d28\u4f53\u5236\u5242\u6539\u53d8\u4e86\u6d3b\u6027\u836f\u7269\u6210\u5206\uff08API\uff09\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\uff08\u5982\u589e\u52a0\u66b4\u9732\u91cf\uff09\u3002\u5982\u679c\u672a\u5305\u5c01\u836f\u7269\u4ee5\u524d\u8fdb\u884c\u4e86EFD\u8bd5\u9a8c\uff0c\u4e14\u53ef\u89c1\u81f4\u7578\u6027\u548c\/\u6216\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\uff0c\u90a3\u4e48\u53ef\u80fd\u4e0d\u5fc5\u518d\u8fdb\u884c\u5355\u72ec\u7684\u8102\u8d28\u4f53\u5236\u5242EFD\u8bd5\u9a8c\u3002\u4f46\u662f\uff0c\u5f53API\u672a\u89c1\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\u65f6\uff0c\u9700\u8981\u8fdb\u884c\u8102\u8d28\u4f53\u5236\u5242EFD\u8bd5\u9a8c\uff0c\u56e0\u4e3a\u8102\u8d28\u4f53\u5236\u5242\u589e\u52a0\u7684\u66b4\u9732\u91cf\u548c\u8102\u8d28\u4f53\u5236\u5242\u4e2d\u65b0\u7684\u6210\u5206\u53ef\u80fd\u4f1a\u5f71\u54cd\u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u3002\u7533\u8bf7\u4eba\u8003\u8651\u7b2c3\u9879\u76ee\u4e0b\u9002\u7528\u60c5\u51b5\u65f6\u53d6\u51b3\u4e8e\u8102\u8d28\u4f53\u5305\u5c01\u7684\u6027\u8d28\u3002\u4f8b\u5982\uff0c\u5f53\u8102\u8d28\u4f53\u5305\u5c01\u7ec6\u80de\u6bd2\u7c7b\u836f\u7269\u65f6\uff0c\u7533\u8bf7\u4eba\u5e94\u8003\u8651\u53c2\u7167\u7b2c3.2\u9879\u76ee\u7684\u7ec6\u80de\u6bd2\u7c7b\u90e8\u5206\u7684\u8981\u6c42\u3002
<\/span><\/p>\n

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\n
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4 \u751f\u80b2\u529b\u8bc4\u4ef7<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

        ICH S9\u4e2d\u7684\u6cbb\u7597\u665a\u671f\u764c\u75c7\u60a3\u8005\u7684\u836f\u7269\u4e00\u822c\u4e0d\u5fc5\u8fdb\u884c\u5355\u72ec\u7684\u751f\u80b2\u529b\u548c\u65e9\u671f\u80da\u80ce\u6bd2\u6027\u7814\u7a76\u3002\u4e00\u822c\u6bd2\u6027\u8bd5\u9a8c\u4e2d\u5bf9\u96c4\u6027\u548c\u96cc\u6027\u751f\u6b96\u5668\u5b98\u7684\u8bc4\u4ef7\uff0c\u4ee5\u53ca\u5176\u5b83\u76f8\u5173\u7ec8\u70b9\uff08\u4f8b\u5982\u6027\u6fc0\u7d20\u7684\u6539\u53d8\uff09\uff0c\u5728\u8bc4\u4f30\u836f\u7269\u5bf9\u751f\u80b2\u529b\u6f5c\u5728\u4f5c\u7528\u65f6\u5e94\u4e88\u8003\u8651\u3002\u4ece\u8fd9\u4e9b\u89c2\u5bdf\u4e2d\u6240\u786e\u5b9a\u7684\u751f\u80b2\u529b\u98ce\u9669\u5e94\u63cf\u8ff0\u5728\u8bf4\u660e\u4e66\u7684\u201c\u81f4\u764c\u6027\u3001\u81f4\u7a81\u53d8\u6027\u3001\u751f\u80b2\u529b\u635f\u4f24\u201d\u90e8\u5206\uff0c\u5e76\u603b\u7ed3\u5728\u8bf4\u660e\u4e66\u7684\u201c\u7537\u6027\u548c\u5973\u6027\u751f\u6b96\u6f5c\u5728\u5f71\u54cd\u201c\u7684\u90e8\u5206\u3002
       \u5f53\u9002\u5e94\u75c7\u4e0d\u662f\u665a\u671f\u80bf\u7624\u65f6\uff0c\u4e00\u822c\u9700\u8981\u8fdb\u884c\u5355\u72ec\u7684\u751f\u80b2\u529b\u8bd5\u9a8c\u3002\u57fa\u4e8e\u603b\u4f53\u6570\u636e\u5206\u6790\uff0c\u5982\u679c\u5355\u72ec\u7684\u751f\u80b2\u529b\u8bd5\u9a8c\u4e0d\u4f1a\u63d0\u4f9b\u6709\u7528\u7684\u4fe1\u606f\uff0c\u90a3\u4e48\u4e0d\u5fc5\u8981\u8fdb\u884c\u5355\u72ec\u7684\u751f\u80b2\u529b\u8bd5\u9a8c\u3002\u4f8b\u5982\uff0c\u7528\u4e8e\u65e9\u671f\u524d\u5217\u817a\u764c\u60a3\u8005\u7684\u836f\u7269\uff0c\u6291\u5236\u96c4\u6027\u6fc0\u7d20\u8fbe\u5230\u53bb\u52bf\u6c34\u5e73\uff0c\u4e0d\u9700\u8981\u8fdb\u884c\u96c4\u6027\u52a8\u7269\uff08\u56e0\u4e3a\u836f\u7269\u88ab\u8ba4\u4e3a\u4f1a\u5bfc\u81f4\u4e0d\u80b2\uff09\u6216\u96cc\u6027\u52a8\u7269\uff08\u56e0\u4e3a\u662f\u96c4\u6027\u4e13\u7528\u836f\uff09\u7684\u751f\u80b2\u529b\u8bd5\u9a8c\u3002\u6b64\u5916\uff0c\u5982\u679c\u4e00\u822c\u6bd2\u6027\u8bd5\u9a8c\u53d1\u73b0\u63d0\u793a\u4e86\u5bf9\u751f\u80b2\u529b\u7684\u4e0d\u826f\u5f71\u54cd\uff08\u4f8b\u5982\u7cbe\u5b50\u6570\u51cf\u5c11\u6216\u8005\u5375\u6ce1\u4e22\u5931\uff09\uff0c\u901a\u5e38\u4e0d\u9700\u8981\u518d\u8fdb\u884c\u5355\u72ec\u7684\u751f\u80b2\u529b\u8bd5\u9a8c\u3002
      \u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u777e\u4e38\u6bd2\u6027\u7684\u8bc4\u4ef7\uff08\u5982FDA\u201c\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u777e\u4e38\u6bd2\u6027\u8bc4\u4ef7\u6307\u5bfc\u539f\u5219\u8349\u6848\u201d\u6240\u63d0\u5230\u7684\uff09\u4e0d\u662f\u5fc5\u9700\u7684\u3002\u56e0\u4e3a\u7531\u4e8e\u6297\u80bf\u7624\u836f\u7269\u7684\u6bd2\u6027\uff0c\u5176\u4e34\u5e8a\u8bd5\u9a8c\u4e00\u822c\u4e0d\u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u4e2d\u8fdb\u884c\uff0c\u6240\u63a8\u8350\u7684\u8bd5\u9a8c\u8bd5\u9a8c\u5728\u80bf\u7624\u60a3\u8005\u4e2d\u7279\u522b\u4e0d\u53ef\u884c\u3002<\/span><\/p>\n

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\n
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5  \u56f4\u4ea7\u671f\u6bd2\u6027\u8bc4\u4ef7<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

        ICH S9\u4e2d\u7684\u6cbb\u7597\u665a\u671f\u764c\u75c7\u60a3\u8005\u7684\u836f\u7269\u53ef\u80fd\u4e0d\u9700\u8fdb\u884c\u56f4\u4ea7\u671f\u6bd2\u6027\u8bd5\u9a8c\u3002\u7136\u800c\uff0c\u5f53\u56f4\u4ea7\u671f\u8bd5\u9a8c\u88ab\u8ba4\u4e3a\u662f\u5fc5\u8981\u65f6\uff08\u57fa\u4e8e\u9002\u5e94\u75c7\uff09\uff0c\u5e94\u8003\u8651\u8fd9\u79cd\u8bd5\u9a8c\u662f\u5426\u80fd\u4e3a\u60a3\u8005\u6216\u533b\u5e08\u63d0\u4f9b\u4fe1\u606f\u3002\u5982\u4ee5\u4e0b\u6848\u4f8b\uff1a
  \u25cf \u81f4\u7578\u6027\u836f\u7269\u53ef\u80fd\u4e0d\u9700\u8fdb\u884c\u56f4\u4ea7\u671f\u6bd2\u6027\u8bd5\u9a8c\u3002\u8fd9\u79cd\u836f\u7269\u9884\u671f\u4f1a\u5bf9\u751f\u5b58\u548c\u4e00\u822c\u5065\u5eb7\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd\uff0c\u5305\u62ec\u540e\u4ee3\u7684\u751f\u957f\u548c\u53d1\u80b2\uff0c\u4e14\u8fd9\u79cd\u98ce\u9669\u5e94\u8be5\u5728\u8bf4\u660e\u4e66\u7684\u201c\u598a\u5a20\u201d\u90e8\u5206\u8fdb\u884c\u63cf\u8ff0\u3002
  \u25cf \u5bf9\u4e8e\u5f15\u8d77\u80da\u80ce-\u80ce\u4ed4\u6b7b\u4ea1\u7684\u836f\u7269\uff0c\u5e94\u8003\u8651\u662f\u5426\u6709\u8db3\u591f\u6570\u91cf\u7684\u5b50\u4ee3\u6765\u8bc4\u4ef7\u5bf9\u53d1\u80b2\u7684\u5f71\u54cd\u3002\u5bf9\u4e8e\u5f15\u8d77\u80da\u80ce-\u80ce\u4ed4\u6b7b\u4ea1\u7684\u836f\u7269\uff0c\u53ef\u80fd\u9700\u8003\u8651\u6539\u826f\u7684\u56f4\u4ea7\u671f\u8bd5\u9a8c\u4ee5\u589e\u52a0\u6d3b\u80ce\u6570\uff0c\u6bd4\u5982\u77ed\u65f6\u95f4\u7a97\u5185\u7ed9\u836f\u3002\u8bd5\u9a8c\u8ba1\u5212\u7684\u4fee\u6539\u4e0d\u5e94\u6539\u53d8\u56f4\u4ea7\u671f\u8bd5\u9a8c\u7684\u76ee\u7684\uff08\u4f8b\u5982\uff0c\u5728\u51fa\u751f\u540e\u5f00\u59cb\u7ed9\u836f\u5c06\u53ea\u80fd\u63d0\u4f9b\u4ea7\u540e\u751f\u957f\u7684\u4fe1\u606f\uff0c\u56e0\u6b64\u8fd9\u6837\u4e0d\u662f\u5fc5\u9700\u7684\uff09\u3002
       <\/span><\/p>\n

\n
\n
\n
6 \u7279\u5b9a\u4eba\u7fa4\u98ce\u9669\u8bc4\u4ef7<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

6.1 \u4ec5\u7528\u4e8e\u7537\u6027\u7684\u836f\u7269
       \u7531\u4e8eEFD\u8bd5\u9a8c\u662f\u7814\u7a76\u80da\u80ce-\u80ce\u4ed4\u53d1\u80b2\u6bd2\u6027\u7684\u98ce\u9669\uff0c\u6240\u4ee5\u5bf9\u4e8e\u7537\u6027\u4e13\u7528\u836f\u7269\uff08\u5982\u524d\u5217\u817a\u764c\uff09\uff0c\u4e0d\u9700\u8981\u8fdb\u884cEFD\u8bd5\u9a8c\u3002\u5982\u7b2c3.1\u9879\u76ee\u7684\u4e00\u822c\u5efa\u8bae\u90e8\u5206\u6240\u8ba8\u8bba\u7684\uff0c\u8bc4\u4ef7\u7cbe\u6db2\u8f6c\u79fb\u5bf9\u4e8e\u53d1\u80b2\u4e2d\u7684\u80da\u80ce\u7684\u98ce\u9669\u4e0d\u662f\u5fc5\u9700\u7684\uff0c\u800c\u662f\u63a8\u8350\u4e00\u6bb5\u65f6\u95f4\u7684\u907f\u5b55\uff08\u89c1\u7b2c8\u9879\u76ee\u7684\u907f\u5b55\u63a8\u8350\uff09\u3002\u907f\u5b55\u4fe1\u606f\u9700\u8981\u5728\u8bf4\u660e\u4e66\u7684\u201c\u7537\u6027\u548c\u5973\u6027\u751f\u6b96\u6f5c\u5728\u5f71\u54cd\u201d\u90e8\u5206\u4e88\u4ee5\u6807\u660e\u3002\u5bf9\u4e8e\u8fd9\u79cd\u60a3\u8005\u4e0d\u5fc5\u8fdb\u884c\u56f4\u4ea7\u671f\u6bd2\u6027\u8bd5\u9a8c\u3002\u5bf9\u4e8e\u975e\u665a\u671f\u80bf\u7624\u9002\u5e94\u75c7\uff08\u4f8b\u5982\u65e9\u671f\u524d\u5217\u817a\u764c\uff09\u5e94\u8003\u8651\u8fdb\u884c\u96c4\u6027\u52a8\u7269\u751f\u80b2\u529b\u8bd5\u9a8c\uff08\u89c1\u7b2c4\u9879\u76ee\u7684\u751f\u80b2\u529b\u8bc4\u4ef7\u90e8\u5206\uff09\u3002
6.2 \u4ec5\u7528\u4e8e\u7edd\u7ecf\u540e\u5987\u5973\u7684\u836f\u7269
       \u4ec5\u7528\u4e8e\u7edd\u7ecf\u540e\u5987\u5973\u7684\u6297\u80bf\u7624\u836f\u7269\u4e0d\u5fc5\u8fdb\u884c\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u3002\u901a\u5e38\uff0c \u201c\u7edd\u7ecf\u201d\u5b9a\u4e49\u4e3a\u65e0\u66ff\u4ee3\u533b\u5b66\u539f\u56e0\u957f\u671f\u505c\u7ecf\u8d85\u8fc712\u4e2a\u6708\uff0c\u6216\u6839\u636e\u5176\u5b83\u56e0\u7d20\u5b9a\u4e49\uff0c\u5982\u8840\u6e05\u4fc3\u5375\u6ce1\u6fc0\u7d20\uff08FSH\uff09\u6c34\u5e73\u548c\u53cc\u4fa7\u5375\u5de2\u5207\u9664\u672f\u3002\u7136\u800c\uff0c\u8fd9\u4e2a\u5b9a\u4e49\u53ca\u5176\u5bf9\u4e8e\u62df\u5b9a\u4e34\u5e8a\u8bd5\u9a8c\u9879\u76ee\u7684\u9002\u7528\u6027\u5e94\u8be5\u4e0eFDA\u76f8\u5173\u7684\u4e34\u5e8a\u5ba1\u8bc4\u90e8\u95e8\u8ba8\u8bba\u3002
6.3 \u513f\u79d1\u7528\u836f
       S9\u4e2d\u7684\u665a\u671f\u764c\u75c7\u7528\u836f\uff0c\u5f53\u9002\u5e94\u75c7\u5305\u62ec\u8fbe\u5230\u9752\u6625\u671f\u60a3\u8005\u65f6\uff0c\u9700\u8981\u8fdb\u884cEFD\u8bd5\u9a8c\u6216EFD\u8bc4\u4ef7\uff08\u5982\u679c\u5408\u9002\uff09\u3002\u8fd9\u901a\u5e38\u5305\u62ec\u5973\u6027\u548c\u7537\u6027\u7684\u751f\u6b96\u6f5c\u529b\u7684\u8bc4\u4f30\uff0c\u4e14\u5305\u62ec\u9752\u5c11\u5e74\uff0812~18\u5c81\uff09\u3002\u5f53\u7528\u836f\u65e8\u5728\u6cbb\u6108\u6216\u5927\u5e45\u5ea6\u63d0\u9ad8\u751f\u5b58\u671f\u65f6\uff0c\u5e94\u8003\u8651\u8fdb\u884c\u5b8c\u6574\u7684\u751f\u6b96\u6bd2\u6027\u7ec4\u5408\u8bd5\u9a8c\uff08\u5373\u751f\u80b2\u529b\u3001EFD\u3001\u56f4\u4ea7\u671f\u6bd2\u6027\u8bd5\u9a8c\uff09\uff0c\u9664\u975e\u8be5\u836f\u5c5e\u4e8e\u524d\u9762\u5df2\u7ecf\u8ba8\u8bba\u8fc7\u7684\u53ef\u80fd\u4e0d\u9700\u8981\u8fdb\u884c\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u7684\u60c5\u51b5\uff08\u89c1\u7b2c3\u9879\u76ee\u5230\u7b2c4.1\u9879\u76ee\u90e8\u5206\uff09\u3002
       <\/span><\/p>\n

\n
\n
\n
7  \u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

7.1 \u4e0d\u6210\u6bd4\u4f8b\u7684\u4ee3\u8c22\u4ea7\u7269
       \u5bf9\u4e8e\u4eba\u4f53\u7279\u5f02\u6027\u4ee3\u8c22\u4ea7\u7269\uff0c\u6216\u8005\u4e0e\u52a8\u7269\u6bd2\u6027\u8bd5\u9a8c\u6bd4\u8f83\u4eba\u4f53\u4e2d\u4e0d\u6210\u6bd4\u4f8b\u9ad8\u6c34\u5e73\u4ee3\u8c22\u4ea7\u7269\uff0c\u53ef\u80fd\u9700\u8981\u989d\u5916\u7684\u4ee3\u8c22\u4ea7\u7269EFD\u8bd5\u9a8c\u3002\u5e94\u8003\u8651\u5728\u52a8\u7269EFD\u8bd5\u9a8c\u4e2d\u7684\u52a8\u7269\u79cd\u5c5e\u4e2d\u662f\u5426\u5177\u6709\u5145\u5206\u7684\u66b4\u9732\uff0c\u4ee3\u8c22\u4ea7\u7269\u7684\u7ed3\u679c\u5305\u542b\u5728API\u8bd5\u9a8c\u7ed3\u679c\u4e2d\u3002\u5f53API\u5177\u6709\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027\u6216\u81f4\u7578\u6027\u65f6\uff0c\u4ee3\u8c22\u4ea7\u7269\u4e0d\u9700\u8981\u8fdb\u884cEFD\u8bd5\u9a8c\u3002
7.2 \u66b4\u9732\u91cf\u6bd4\u8f83
       EFD\u8bd5\u9a8c\u5e94\u6536\u96c6\u836f\u4ee3\u52a8\u529b\u5b66\u6570\u636e\uff0c\u4e14\u8bf4\u660e\u4e66\u7684\u201c\u598a\u5a20\u201d\u90e8\u5206\u5e94\u6807\u660e\u52a8\u7269\u4e0e\u4eba\u7684\u66f2\u7ebf\u4e0b\u9762\u79ef\uff08AUC\uff09\u6bd4\u4f8b\u3002\u5f53EFD\u8bd5\u9a8c\u672a\u83b7\u5f97\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u65f6\uff0c\u5f53\u5408\u9002\u65f6\uff08\u4f8b\u5982\uff0c\u57fa\u4e8e\u5236\u5242\u7684\u5dee\u5f02\uff09\u53ef\u4ee5\u91c7\u7528\u6765\u81ea\u4e8e\u91c7\u7528\u76f8\u540c\u7684\u52a8\u7269\u79cd\u5c5e\u3001\u5242\u91cf\u3001\u7ed9\u836f\u9014\u5f84\u3001\u7ed9\u836f\u65b9\u6848\u7684\u4e00\u822c\u6bd2\u6027\u8bd5\u9a8c\u4e2d\u7684\u52a8\u7269AUC \u3002
      <\/span><\/p>\n

\n
\n
\n
8  \u907f\u5b55\u63a8\u8350<\/section>\n
<\/section>\n<\/section>\n<\/section>\n<\/section>\n

        \u5f53\u786e\u5b9a\u6297\u80bf\u7624\u836f\u7269\u7684\u53d1\u80b2\u6bd2\u6027\u98ce\u9669\u4e4b\u540e\uff0c\u8bf4\u660e\u4e66\u4e2d\u5e94\u5411\u60a3\u8005\u63d0\u4f9b\u505c\u6b62\u6cbb\u7597\u540e\u7684\u907f\u5b55\u65f6\u95f4\u4fe1\u606f\u3002\u8bf4\u660e\u4e66\u7684\u201c\u5973\u6027\u548c\u7537\u6027\u751f\u6b96\u6f5c\u5728\u5f71\u54cd\u201d\u90e8\u5206\u9700\u8981\u5305\u542b\u63a8\u8350\u7684\u7537\u6027\u548c\u5973\u6027\u7528\u836f\u540e\u7684\u907f\u5b55\u671f\uff0c\u4ee5\u6700\u5c0f\u5316EFD\u98ce\u9669\u548c\u63a5\u53d7\u6297\u80bf\u7624\u836f\u7269\u6cbb\u7597\u7537\u6027\u60a3\u8005\u7684\u5973\u6027\u4f34\u4fa3\u7684\u98ce\u9669\u3002
       \u4e0b\u8ff08.1\u9057\u4f20\u6bd2\u6027\u836f\u7269\u548c8.2\u975e\u9057\u4f20\u6bd2\u6027\u836f\u7269\u90e8\u5206\u4e2d\u7684\u5efa\u8bae\u7684\u79d1\u5b66\u57fa\u7840\uff0c\u662f\u57fa\u4e8e\u5bf9\u914d\u5b50\u53d1\u751f\u548c\u6b64\u8fc7\u7a0b\u4e2d\u7684\u6027\u522b\u5dee\u5f02\u7684\u8ba4\u8bc6\u3002\u8fd9\u4e9b\u63a8\u8350\u57fa\u4e8e\u53d1\u80b2\u6bd2\u6027\uff08\u6bd4\u5982\u7578\u5f62\u548c\u81f4\u6b7b\u6027\uff09\u7684\u9884\u9632\uff0c\u800c\u4e0d\u662f\u751f\u80b2\u529b\u7684\u6062\u590d\u3002
        \u867d\u7136\u4ee5\u4e0b\u63a8\u8350\u65e8\u5728\u51cf\u5c11\u6bcd\u4f53\u836f\u7269\u7684\u66b4\u9732\uff0c\u4f46\u4e5f\u53ef\u4ee5\u901a\u8fc7\u51cf\u5c11\u4ee3\u8c22\u4ea7\u7269\u7684\u66b4\u9732\u800c\u964d\u4f4e\u53d1\u80b2\u6bd2\u6027\uff08\u4f8b\u5982\u9057\u4f20\u6bd2\u6027\u4ee3\u8c22\u4ea7\u7269\uff09\u3002
8.1 \u9057\u4f20\u6bd2\u6027\u836f\u7269<\/span><\/p>\n

8.1.1 \u7537\u6027
      \u9057\u4f20\u6bd2\u6027\u836f\u7269\u53ef\u80fd\u9020\u6210\u7cbe\u5b50\u4e2d\u7684\u8131\u6c27\u6838\u7cd6\u6838\u9178\uff08DNA\uff09\u635f\u4f24\uff0c\u4ece\u800c\u6709\u53ef\u80fd\u5bf9\u5176\u5973\u6027\u4f34\u4fa3\u7684\u80da\u80ce\u4ea7\u751f\u4e0d\u826f\u5f71\u54cd\u3002\u867d\u7136\u8fd8\u6ca1\u6709\u5173\u4e8e\u4f7f\u7528\u6297\u80bf\u7624\u836f\u7269\u7537\u6027\u60a3\u8005\u540e\u4ee3\u7578\u5f62\u7387\u4e0a\u5347\u7684\u62a5\u9053\uff0c\u4f46\u662f\u53ef\u4ee5\u5728\u7ed9\u4e88\u6297\u80bf\u7624\u836f\u7269\u7684\u96c4\u6027\u52a8\u7269\u548c\u6b63\u5e38\u96cc\u6027\u52a8\u7269\u4ea4\u914d\u7684\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230\u8fd9\u79cd\u4f5c\u7528\u3002\u6297\u80bf\u7624\u6cbb\u7597\u505c\u6b62\u540e3\u4e2a\u6708\u7684\u907f\u5b55\u671f\u5c06\u6700\u5c0f\u5316\u534a\u8870\u671f\u8f83\u77ed\uff08\u5c11\u4e8e1\u5468\uff09\u7684\u9057\u4f20\u6bd2\u6027\u836f\u7269\u5bf9\u80da\u80ce-\u80ce\u4ed4\u7684\u4e0d\u826f\u5f71\u54cd\u3002\u4eba\u4f53\u7cbe\u5b50\u53d1\u751f\u5468\u671f\u5927\u7ea6\u4e3a70\u5929\u30023\u4e2a\u6708\u8003\u8651\u4e86\u836f\u7269\u7684\u534a\u8870\u671f\u548c\u4f53\u5185\u7cbe\u5b50\u7684\u5b58\u6d3b\u65f6\u95f4\u3002\u5bf9\u4e8e\u8f83\u957f\u534a\u8870\u671f\uff081\u5468\u62161\u5468\u4ee5\u4e0a\uff09\u7684\u836f\u7269\uff0c\u63a8\u8350\u518d\u589e\u52a05\u4e2a\u534a\u8870\u671f\u7684\u907f\u5b55\u671f\u3002\u89c1\u88681\u3002
8.1.2\u5973\u6027
      \u9057\u4f20\u6bd2\u6027\u836f\u7269\u53ef\u80fd\u76f4\u63a5\u5f71\u54cd\u80da\u80ce\/\u80ce\u513f\uff0c\u6216\u53ef\u80fd\u9020\u6210\u5375\u6bcd\u7ec6\u80de\u7684DNA\u635f\u4f24\u3002\u5375\u6ce1\u751f\u957f\u5468\u671f\u5927\u7ea6\u662f6\u81f312\u6708\u3002\u5728\u8d77\u59cb\u9636\u6bb5\uff08\u539f\u59cb\u5375\u6ce1\uff09\u66b4\u9732\u4e8e\u9057\u4f20\u6bd2\u6027\u836f\u7269\u5c06\u4e3b\u8981\u5bfc\u81f4\u5375\u6ce1\u4e22\u5931\u3002\u4fdd\u7559\u5728\u5375\u6ce1\u4e2d\u7684\u635f\u4f24\u53ef\u80fd\u901a\u8fc7\u81ea\u7136\u7684\u5375\u6ce1\u95ed\u9501\u8fc7\u7a0b\u800c\u88ab\u8fdb\u4e00\u6b65\u6e05\u9664\uff08\u6e05\u9664\u7387\u4e3a90%\u4ee5\u4e0a\uff09\u3002\u5375\u6ce1\u751f\u957f\u7684\u751f\u957f\u671f\u548c\u6210\u719f\u671f\uff084~6\u4e2a\u6708\uff09\u5bf9\u6301\u7eed\u7684DNA\u635f\u4f24\u662f\u6700\u654f\u611f\u7684\uff0c\u5f88\u53ef\u80fd\u5bfc\u81f4\u80da\u80ce-\u80ce\u4ed4\u7578\u5f62\u3002\u56e0\u6b64\uff0c\u9057\u4f20\u6bd2\u6027\u836f\u7269\u505c\u6b62\u6cbb\u7597\u540e\u63a8\u83506\u4e2a\u6708\u7684\u907f\u5b55\u671f\u3002\u5bf9\u4e8e\u8f83\u957f\u534a\u8870\u671f\uff081\u5468\u62161\u5468\u4ee5\u4e0a\uff09\u7684\u836f\u7269\uff0c\u63a8\u8350\u589e\u52a05\u4e2a\u534a\u8870\u671f\u7684\u907f\u5b55\u671f\u3002\u89c1\u88681\u3002<\/span><\/p>\n

  \u88681  \u9057\u4f20\u6bd2\u6027\uff08\u5305\u62ec\u591a\u500d\u4f53\u8bf1\u5bfc\u4f5c\u7528\u7684\uff09\u836f\u7269\uff1a\u505c\u6b62\u6cbb\u7597\u540e\u907f\u5b55\u7684\u5efa\u8bae<\/span>
<\/span><\/p>\n\n\n\n\n\n
\n

\u7537\u6027<\/span><\/p>\n<\/td>\n

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\u5973\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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3\u4e2a\u6708a<\/span><\/p>\n<\/td>\n

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6\u4e2a\u6708<\/span><\/p>\n<\/td>\n<\/tr>\n

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3\u4e2a\u6708+5\u4e2aT1\/2b\uff08\u957f\u534a\u8870\u671f\u836f\u7269c\uff09<\/span><\/p>\n<\/td>\n

\n

6\u4e2a\u6708+5\u4e2aT1\/2b\uff08\u957f\u534a\u8870\u671f\u836f\u7269c\uff09<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

a\u7cbe\u5b50\u53d1\u751f\u5468\u671f\u548c\u4f53\u5185\u7cbe\u5b50\u5b58\u6d3b\u65f6\u95f4
b\u534a\u8870\u671f
c\u534a\u8870\u671f1\u5468\u62161\u5468\u4ee5\u4e0a\u4e3a\u957f\u534a\u8870\u671f<\/span><\/p>\n


<\/p>\n

8.2 \u975e\u9057\u4f20\u6bd2\u6027\u836f\u7269<\/span><\/p>\n

8.2.1 \u7537\u6027
      \u7cbe\u6db2\u4e2d\u836f\u7269\u7684\u5b58\u5728\u5177\u6709\u7406\u8bba\u4e0a\u7684\u81f4\u7578\u98ce\u9669\u3002\u867d\u7136\u6709\u62a5\u9053\u63d0\u793a\u4f7f\u7528\u6297\u80bf\u7624\u836f\u7269\u7684\u7537\u6027\u7684\u540e\u4ee3\u7578\u5f62\u7387\u6ca1\u6709\u4e0a\u5347\uff0c\u4f46\u662f\u6ca1\u6709\u4e13\u95e8\u8003\u5bdf\u505c\u6b62\u6cbb\u7597\u7b2c\u4e00\u5e74\u7684\u51fa\u751f\u60c5\u51b5\u7684\u62a5\u9053\u30022014\u5e74\u53d1\u8868\u7684\u79d1\u6280\u6587\u7ae0\u8868\u660e\u5305\u62ec\u6c99\u5229\u5ea6\u80fa\u5728\u5185\u7684\u836f\u7269\u9634\u9053\u5185\u7ed9\u836f\uff0c\u5728\u4e34\u5e8a\u76f8\u5173\u6d53\u5ea6\u4e0b\u672a\u9020\u6210\u80da\u80ce\u7578\u5f62\u3002\u5c3d\u7ba1\u5982\u6b64\uff0c\u66f4\u65e9\u671f\u7684\u7814\u7a76\u89c2\u5bdf\u5230\u96c4\u6027\u5154\u7ed9\u4e88\u6c99\u5229\u5ea6\u80fa\u5bf9\u80da\u80ce-\u80ce\u4ed4\u4ea7\u751f\u4e0d\u826f\u5f71\u54cd\u3002\u867d\u7136\u6c99\u5229\u5ea6\u80fa\u4e0d\u4f1a\u5728\u7cbe\u6db2\u4e2d\u84c4\u79ef\uff0c\u4f46\u662f\u8bb8\u591a\u5c0f\u5206\u5b50\u836f\u7269\u53ef\u4ee5\u5728\u7cbe\u6db2\u4e2d\u84c4\u79ef\uff0c\u800c\u4e14\u5173\u4e8e\u7cbe\u6db2\u8f6c\u79fb\u9020\u6210\u7684\u80da\u80ce-\u80ce\u4ed4\u6bd2\u6027\u7684\u7814\u7a76\u8fd8\u6bd4\u8f83\u6709\u9650\u3002\u7531\u4e8e\u5b58\u5728\u6570\u636e\u7f3a\u53e3\uff0c\u5bf9\u4e8e\u5c0f\u5206\u5b50\u81f4\u7578\u6027\u836f\u7269\uff0c\u63a8\u83505\u4e2a\u534a\u8870\u671f\u518d\u52a0\u4e0a3\u5468\uff08\u8003\u8651\u5230\u4f53\u5185\u7cbe\u5b50\u7684\u836f\u7269\u5b58\u7559\uff09\u4f5c\u4e3a\u907f\u5b55\u671f\u3002\u4f46\u662f\uff0c\u5bf9\u4e8e\u81f4\u7578\u6027\u751f\u7269\u5236\u54c1\uff0c\u5bf9\u4e8e\u7537\u6027\u4e0d\u63a8\u8350\u907f\u5b55\u671f\uff0c\u56e0\u4e3a\u8fd9\u7c7b\u751f\u7269\u5236\u54c1\u4e0d\u4f1a\u5728\u7cbe\u6db2\u4e2d\u84c4\u79ef\u3001\u5438\u6536\u6709\u9650\u3001\u53ef\u80fd\u56e0\u9634\u9053\u548c\u5b50\u5bab\u9888\u7684\u9176\u800c\u86cb\u767d\u964d\u89e3\u3002\u89c1\u88682\u3002
8.2.2\u5973\u6027
      \u505c\u6b62\u6cbb\u7597\u540e\u907f\u5b555\u4e2a\u534a\u8870\u671f\u53ef\u4ee5\u4f7f\u5927\u7ea697%\u7684\u53d1\u80b2\u6bd2\u6027\u836f\u7269\u5728\u53d7\u7cbe\u524d\u4ece\u5faa\u73af\u7cfb\u7edf\u4e2d\u6e05\u9664\u3002\u5bf9\u4e8e\u77ed\u534a\u8870\u671f\u7684\u836f\u7269\uff0c\u63a8\u8350\u505c\u6b62\u6cbb\u7597\u540e\u81f3\u5c1130\u5929\uff08\u4e00\u4e2a\u6708\u7ecf\u5468\u671f\uff09\u7684\u907f\u5b55\u671f\u3002\u89c1\u88682\u3002
       <\/span><\/p>\n

\u88682  \u975e\u9057\u4f20\u6bd2\u6027\u836f\u7269\uff1a\u505c\u6b62\u6cbb\u7597\u540e\u907f\u5b55\u7684\u5efa\u8bae<\/span>
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\u7537\u6027<\/span><\/p>\n<\/td>\n

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\u5973\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

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\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027<\/span><\/p>\n<\/td>\n

\n

\u975e\u81f4\u7578\u6027\u548c\u975e\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027<\/span><\/p>\n<\/td>\n

\n

\u81f4\u7578\u6027\u6216\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027<\/span><\/p>\n<\/td>\n

\n

\u975e\u81f4\u7578\u6027\u548c\u975e\u80da\u80ce-\u80ce\u4ed4\u81f4\u6b7b\u6027<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5c0f\u5206\u5b50\uff1a5\u4e2a\u534a\u8870\u671f+3\u5468<\/span><\/p>\n<\/td>\n

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\u4e0d\u5fc5\u8981<\/span><\/p>\n<\/td>\n

\n

5\u4e2a\u534a\u8870\u671f\u6216\u4e00\u4e2a\u6708\u7ecf\u5468\u671f\uff0830\u5929\uff09\uff0c\u53d6\u5176\u4e2d\u66f4\u957f\u8005<\/span><\/p>\n<\/td>\n

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\u4e0d\u5fc5\u8981<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u751f\u7269\u5236\u54c1\uff1a\u4e0d\u5fc5\u8981<\/span> <\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u7ffb\u8bd1\uff1a \u53f6\u65cb
\u6821\u5bf9\uff1a\u9ec4\u82b3\u534e\u3001\u738b\u6d77\u5b66
\u53c2\u8003\u6587\u732e\uff1aOncology Pharmaceuticals:Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry\u3002FDA guideline\uff0c09\/28\/2017<\/span><\/p>\n


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\u6587\u7ae0\u4fe1\u606f<\/span>\u6e90<\/span>\u4e8e\u516c\u4f17\u53f7<\/span>\u6297\u4f53\u5708\uff0c<\/span>\u767b\u8f7d<\/span>\u8be5\u6587\u7ae0\u76ee\u7684\u4e3a\u66f4\u5e7f\u6cdb\u7684\u4f20\u9012\u884c\u4e1a\u4fe1\u606f\uff0c\u4e0d\u4ee3\u8868\u8d5e\u540c\u5176\u89c2\u70b9\u6216\u5bf9\u5176\u771f\u5b9e\u6027\u8d1f\u8d23\u3002\u6587\u7ae0\u7248\u6743\u5f52\u539f\u4f5c\u8005\u53ca\u539f\u51fa\u5904\u6240\u6709\uff0c\u6587\u7ae0\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\u3002\u672c\u7f51\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\uff0c\u82e5\u65e0\u610f\u4fb5\u72af\u7248\u6743\uff0c\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5b66\u5982\u9006\u6c34\u884c\u821f\uff0c\u4e0d\u8fdb\u5219\u9000\uff1b<\/span><\/p>\n

\u5fc3\u4f3c\u5e73\u539f\u8d70\u9a6c\uff0c\u6613\u653e\u96be\u6536\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\"FDA\u5173\u4e8e\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u548c\u8bf4\u660e\u4e66\u5efa\u8bae\u7684\u6307\u5bfc\u539f\u5219\uff08\u8349\u6848\uff09\"<\/p>\n


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

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\u6bcf\u65e5\u66f4\u65b0 \u6b22\u8fce\u8ba2\u9605+<\/span><\/p>\n

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<\/p>\n

\"FDA\u5173\u4e8e\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96\u6bd2\u6027\u8bd5\u9a8c\u548c\u8bf4\u660e\u4e66\u5efa\u8bae\u7684\u6307\u5bfc\u539f\u5219\uff08\u8349\u6848\uff09\"<\/p>\n<\/section>\n


<\/p>\n

\u533b\u836f\u5927\u6570\u636e|\u884c\u4e1a\u52a8\u6001|\u653f\u7b56\u89e3\u8bfb<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u70b9\u51fb\u4e0a\u65b9\u7684  \u25b2 \u6dfb\u52a0\u5173\u6ce8 FDA\u4e8e2017\u5e749\u670828\u65e5\u53d1\u5e03\u4e86\u5173\u4e8e\u6297\u80bf\u7624\u836f\u7269\u751f\u6b96 […]<\/p>\n","protected":false},"author":1,"featured_media":85657,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/85656"}],"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=85656"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/85656\/revisions"}],"predecessor-version":[{"id":85660,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/85656\/revisions\/85660"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/85657"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=85656"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=85656"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=85656"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}