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\"\u5c0f\u725b\u4e34\u7814<\/figure>\n\n\n\n

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1. \u8c01\u62a5\u544a\uff1f\uff08\u8d23\u4efb\u4e3b\u4f53\uff09<\/strong><\/p>\n\n\n\n

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  • \u6838\u5fc3\u539f\u5219<\/strong>\uff1a\u7533\u529e\u8005\uff08\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u4eba\uff09\u662fDSUR\u7684\u552f\u4e00\u8d23\u4efb\u4e3b\u4f53<\/strong>\uff0c\u5bf9\u62a5\u544a\u7684\u5185\u5bb9\u3001\u8d28\u91cf\u548c\u6309\u65f6\u63d0\u4ea4\u8d1f\u6700\u7ec8\u8d23\u4efb\u3002<\/li>\n\n\n\n
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        \n
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      • \u7279\u8272\u8981\u6c42<\/strong>\uff1a\u5fc5\u987b\u5305\u542b\u4e2d\u56fd\u7684\u201c\u533a\u57df\u7279\u6709\u4fe1\u606f\u201d\uff0c\u4f8b\u5982\u5883\u5185\u6b7b\u4ea1\u53d7\u8bd5\u8005\u5217\u8868\u3001\u56e0\u4e0d\u826f\u4e8b\u4ef6\u9000\u51fa\u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u5217\u8868\u3001\u4ee5\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u53d8\u66f4\u7b49\u5185\u5bb9\u7684\u603b\u7ed3\u8868\u3002<\/li>\n\n\n\n
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      • \u62a5\u544a\u5230\u4f55\u65f6\uff1f\uff08\u5468\u671f\u4e0e\u7ec8\u6b62\uff09<\/strong><\/li>\n\n\n\n
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      • \u7ec8\u6b62\u65f6\u70b9<\/strong>\uff1a\u6301\u7eed\u63d0\u4ea4\u81f3\u8be5\u836f\u7269\u5728\u4e2d\u56fd\u63d0\u4ea4\u6700\u540e\u4e00\u4e2a\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff0c\u6216\u5728\u4e2d\u56fd\u660e\u786e\u7ec8\u6b62\u7814\u53d1\u4e3a\u6b62\u3002<\/li>\n<\/ul>\n\n\n\n

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          \n
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        • \u6848\u4f8b\u52a9\u89e3<\/strong>\uff1a<\/li>\n<\/ul>\n\n\n\n

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            <\/ol>\n\n\n\n
              <\/ol>\n\n\n\n
              \"\"<\/figure>\n\n\n\n

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                <\/ol>\n\n\n\n
                \"\"<\/figure>\n\n\n\n

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                2. \u54ea\u4e9b\u60c5\u51b5\u5fc5\u987b\u4ea4\uff1f\u54ea\u4e9b\u53ef\u80fd\u4e0d\u7528\u4ea4\uff1f\uff08\u8303\u56f4\u6f84\u6e05\uff09<\/strong><\/p>\n\n\n\n

                  \n
                • \u5fc5\u987b\u4ea4\uff08\u6838\u5fc3\uff09<\/strong>\uff1a\u6240\u6709\u4ee5\u83b7\u5f97\u6ce8\u518c\u4e0a\u5e02\u4e3a\u76ee\u7684\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5305\u62ecI\u3001II\u3001III\u671f\uff0c\u6279\u4ef6\u8981\u6c42\u7684BE\u6216IV\u671f\u8bd5\u9a8c\uff0c\u5df2\u4e0a\u5e02\u836f\u54c1\u589e\u52a0\u65b0\u9002\u5e94\u75c7\u6216\u91cd\u5927\u53d8\u66f4\u6240\u9700\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7b49\u6309\u8981\u6c42\u5747\u5fc5\u987b\u63d0\u4ea4DSUR\u3002<\/li>\n\n\n\n
                • \u4e0d\u7528\u4ea4\uff08\u7279\u4f8b\uff09<\/strong>\uff1a\u4ec5\u4e3a\u8fdb\u884c\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u3001\u4ec5\u4ee5\u5907\u6848\u5f62\u5f0f\u5f00\u5c55\u7684BE\u8bd5\u9a8c<\/strong>\uff0c\u539f\u5219\u4e0a\u53ef\u4e0d\u9012\u4ea4\u3002\u4f46\u82e5\u540c\u65f6\u5b58\u5728\u5176\u4ed6\u9700\u9012\u4ea4DSUR\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5219\u4ecd\u9700\u9012\u4ea4\u3002<\/li>\n\n\n\n
                • \u5e38\u89c1\u8bef\u533a\u7ea0\u6b63<\/strong>\uff1a
                  • \u83b7\u6279\u4f46\u672a\u542f\u52a8\u8bd5\u9a8c<\/strong>\uff1a\u4e5f\u8981\u4ea4\uff0c\u62a5\u544a\u5468\u671f\u5185\u65e0\u8fdb\u5c55\u4e5f\u9700\u5728\u76f8\u5e94\u7ae0\u8282\u8bf4\u660e\uff0c\u4e0d\u53ef\u7701\u7565\u3002<\/li><\/ul>
                    • \u5883\u5185\u65e0\u8bd5\u9a8c\uff0c\u5883\u5916\u6709\u8bd5\u9a8c<\/strong>\uff1a\u5411\u4e2d\u56fd\u63d0\u4ea4\u7684DSUR\u4ecd\u9700\u5305\u542b\u5883\u5916\u6240\u6709\u76f8\u5173\u5b89\u5168\u6027\u6570\u636e\u3002<\/li><\/ul>\n
                        \n
                      • 2018\u5e7450\u53f7\u516c\u544a\u524d\u83b7\u6279\u7684\u201c\u8001\u8bd5\u9a8c\u201d<\/strong>\uff1a\u539f\u5219\u4e0a\u81ea\u884c\u51b3\u5b9a\u3002\u4f46\u82e5\u76f8\u540c\u6210\u5206\u5728\u516c\u544a\u540e\u83b7\u6279\u4e86\u65b0\u8bd5\u9a8c\uff0c\u5219\u9700\u9012\u4ea4DSUR\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n
                      • <\/li>\n<\/ul>\n\n\n\n

                        3. \u201c\u65e0\u8fdb\u5c55\u62a5\u544a\u201d\u600e\u4e48\u5199\uff1f<\/strong><\/p>\n\n\n\n

                        \u8fd9\u662f\u76d1\u7ba1\u660e\u786e\u8981\u6c42\u7684\u91cd\u70b9\u3002\u5373\u4f7f\u62a5\u544a\u5468\u671f\u5185\u6ca1\u6709\u4efb\u4f55\u53d7\u8bd5\u8005\u5165\u7ec4\u6216\u4efb\u4f55\u5b89\u5168\u6027\u4e8b\u4ef6\u53d1\u751f\uff0c\u4f60\u4e5f\u4e0d\u80fd\u7701\u7565\u7ae0\u8282\u6216\u4ec5\u5199\u201c\u65e0\u201d<\/strong>\u3002\u5fc5\u987b\u6309\u7167ICH E2F\u7684\u5b8c\u6574\u683c\u5f0f\uff0c\u5728\u6bcf\u4e00\u4e2a\u76f8\u5e94\u7684\u7ae0\u8282\uff08\u5982\u7d2f\u8ba1\u66b4\u9732\u91cf\u3001\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u5217\u8868\u7b49\uff09\u4e2d\uff0c\u660e\u786e\u9648\u8ff0\u201c\u672c\u62a5\u544a\u5468\u671f\u5185\u65e0\u76f8\u5173\u8fdb\u5c55\/\u53d1\u73b0\u201d\u3002\u8fd9\u4f53\u73b0\u4e86\u6301\u7eed\u76d1\u7ba1\u548c\u7cfb\u7edf\u6027\u56de\u987e\u7684\u539f\u5219\u3002<\/p>\n\n\n\n

                        4<\/strong>. \u9047\u5230\u7279\u6b8a\u60c5\u51b5\u600e\u4e48\u529e\uff1f\uff08\u5b98\u65b9\u6307\u5f15\uff09<\/strong><\/p>\n\n\n\n

                          \n
                        • \u8054\u5408\u7528\u836f\uff08\u5982\u80bf\u7624\u836fA+B\uff09<\/strong>\uff1a\u4e3a\u4fdd\u8bc1\u6570\u636e\u5b8c\u6574\u6027\uff0c\u5b98\u65b9\u5efa\u8bae\u5bf9A\u548cB\u5206\u522b\u9012\u4ea4DSUR<\/strong>\uff0c\u4e14\u6bcf\u4efd\u62a5\u544a\u90fd\u5e94\u5305\u542b\uff08A+B\uff09\u8054\u5408\u6cbb\u7597\u7684\u6570\u636e\u3002<\/li>\n\n\n\n
                        • \u7533\u529e\u65b9\u53d8\u66f4<\/strong>\uff1a\u7531\u53d8\u66f4\u540e\u7684\u7533\u529e\u8005\u8d1f\u8d23\u540e\u7eedDSUR\u7684\u9012\u4ea4\u3002<\/li>\n\n\n\n
                        • \u7814\u53d1\u4e2d\u6b62\u540e\u53c8\u91cd\u542f<\/strong>\uff1a\u9700\u8981\u91cd\u65b0\u9012\u4ea4DSUR\u3002\u82e5\u4e2d\u65ad\u671f\u95f4\u6709\u65b0\u7684\u91cd\u8981\u5b89\u5168\u6027\u4fe1\u606f\uff0c\u5e94\u5728\u91cd\u542f\u540e\u7684\u9996\u4efdDSUR\u4e2d\u7eb3\u5165\u3002<\/li>\n\n\n\n
                        • DSUR\u548c\u4e0a\u5e02\u540e\u7684PSUR\u662f\u4ec0\u4e48\u5173\u7cfb<\/strong>\uff1f<\/strong><\/li>\n<\/ul>\n\n\n\n

                          \u8fd9\u662f\u6700\u5bb9\u6613\u6df7\u6dc6\u7684\u6982\u5ff5\u3002\u7b80\u5355\u6765\u8bf4\uff1a<\/p>\n\n\n\n

                            \n
                          • DSUR<\/strong>\uff1a\u7ba1\u201c\u7814\u53d1\u4e2d\u201d\u7684\u4e8b\uff0c\u4fa7\u91cd\u8bd5\u9a8c\u836f\u7269\u672c\u8eab\uff0c\u9012\u4ea4\u7ed9CDE\u3002<\/li>\n\n\n\n
                          • PSUR<\/strong>\uff1a\u7ba1\u201c\u4e0a\u5e02\u540e\u201d\u7684\u4e8b\uff0c\u4fa7\u91cd\u5df2\u6279\u51c6\u836f\u54c1\u7684\u5168\u8c8c\uff0c\u9012\u4ea4\u7ed9\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u3002<\/li>\n\n\n\n
                          • \u5173\u952e\u5173\u7cfb<\/strong>\uff1a\u4e8c\u8005\u72ec\u7acb\u3001\u4e0d\u53ef\u4e92\u76f8\u66ff\u4ee3<\/strong>\u3002\u5982\u679c\u4e00\u4e2a\u5df2\u4e0a\u5e02\u836f\u54c1\u4ecd\u5728\u8fdb\u884c\u65b0\u9002\u5e94\u75c7\u7b49\u4e34\u5e8a\u7814\u7a76\uff0c\u5219\u9700\u540c\u65f6\u63d0\u4ea4<\/strong>DSUR\u548cPSUR\u3002\u4e3a\u65b9\u4fbf\u7ba1\u7406\uff0c\u4f01\u4e1a\u53ef\u9009\u62e9\u5c06DSUR\u7684\u62a5\u544a\u5468\u671f\u8c03\u6574\u81f3\u4e0ePSUR\u7684\u201c\u56fd\u9645\u8bde\u751f\u65e5\uff08IBD\uff09\u201d\u540c\u6b65\u3002<\/li>\n\n\n\n
                          • \u957f\u671f\u968f\u8bbf\u8bd5\u9a8c\u9700\u8981\u4ea4DSUR\u5417\uff1f<\/strong><\/li>\n<\/ul>\n\n\n\n

                            \u5bf9\u4e8e\u4e3b\u8bd5\u9a8c\u7ed3\u675f\u540e\uff0c\u5728\u4e0a\u5e02\u7533\u8bf7\u5ba1\u8bc4\u671f\u95f4\u6216\u83b7\u6279\u4e0a\u5e02\u540e\u4ecd\u5728\u8fdb\u884c\u7684\u957f\u671f\u968f\u8bbf\uff08\u5982\u751f\u5b58\u671f\u968f\u8bbf\uff09\uff0c\u7531\u7533\u529e\u8005\u81ea\u884c\u8bc4\u4f30<\/strong>\u662f\u5426\u9700\u8981\u9012\u4ea4DSUR\u81f3\u968f\u8bbf\u7ed3\u675f\uff0c\u9664\u975e\u76d1\u7ba1\u673a\u6784\u6709\u7279\u6b8a\u8981\u6c42\u3002\u8fd9\u7ed9\u4e88\u4e86\u4f01\u4e1a\u4e00\u5b9a\u7684\u7075\u6d3b\u6027\uff0c\u4f46\u9700\u57fa\u4e8e\u98ce\u9669\u8fdb\u884c\u8bc4\u4f30\u3002<\/strong><\/p>\n\n\n\n

                              \n
                            • DSUR\u91cc\u9700\u8981\u5199\u201c\u6709\u6548\u6027\u201d\u4fe1\u606f\u5417\uff1f<\/strong><\/li>\n<\/ul>\n\n\n\n

                              \u5728\u201c\u6574\u4f53\u5b89\u5168\u6027\u8bc4\u4f30\u201d\u7ae0\u8282\u4e2d\u7684\u201c\u83b7\u76ca-\u98ce\u9669\u8003\u91cf\u201d\u90e8\u5206\uff0c\u9f13\u52b1\u7533\u529e\u8005\u8865\u5145\u6709\u6548\u6027\u4fe1\u606f<\/strong>\u3002\u8fd9\u6709\u52a9\u4e8e\u76d1\u7ba1\u673a\u6784\u4ece\u6574\u4f53\u83b7\u76ca-\u98ce\u9669\u89d2\u5ea6\u8fdb\u884c\u79d1\u5b66\u8bc4\u4ef7\u3002\u4f46\u6838\u5fc3\u4ecd\u662f\u57fa\u4e8e\u5b89\u5168\u6027\u6570\u636e\u8bc6\u522b\u98ce\u9669\uff0c\u5e76\u8bf4\u660e\u4e0e\u9884\u671f\u83b7\u76ca\u7684\u5e73\u8861\u5173\u7cfb\u662f\u5426\u53d1\u751f\u53d8\u5316\u3002<\/p>\n\n\n\n

                                \n
                              • \u9012\u4ea4\u540e\uff0c\u76d1\u7ba1\u673a\u6784\u4f1a\u5ba1\u6838\u5417\uff1f <\/strong><\/li>\n<\/ul>\n\n\n\n

                                \u4f1a\u3002\u836f\u5ba1\u4e2d\u5fc3\u5c06\u5728\u6536\u5230DSUR\u540e\u7684180\u4e2a\u5de5\u4f5c\u65e5<\/strong>\u5185\u8fdb\u884c\u5ba1\u6838\u3002\u5ba1\u6838\u610f\u89c1\u4f1a\u901a\u8fc7\u3010\u7533\u8bf7\u4eba\u4e4b\u7a97\u3011\u7684\u76f8\u5e94\u680f\u76ee\u53cd\u9988\u3002\u82e5180\u5929\u5185\u65e0\u53cd\u9988\uff0c\u5219\u89c6\u4e3a\u5f52\u6863\u5904\u7406\u3002\u9700\u6ce8\u610f\uff0cDSUR\u4e0d\u5e94\u4f5c\u4e3a\u65b0\u7684\u91cd\u8981\u5b89\u5168\u6027\u4fe1\u606f\u7684\u9996\u6b21\u62a5\u544a\u9014\u5f84<\/strong>\uff0c\u7d27\u6025\u5b89\u5168\u6027\u95ee\u9898\u4ecd\u9700\u901a\u8fc7\u5feb\u901f\u62a5\u544a\u7a0b\u5e8f\u4e0a\u62a5\u3002<\/strong><\/p>\n\n\n\n

                                  \n
                                • \u5982\u4f55\u51c6\u5907\u201c\u7d2f\u8ba1\u66b4\u9732\u91cf\u201d\u6570\u636e\uff1f<\/strong><\/li>\n<\/ul>\n\n\n\n

                                  \u8fd9\u662fDSUR\u7684\u6838\u5fc3\u6570\u636e\u4e4b\u4e00\uff0c\u7528\u4ee5\u8bc4\u4f30\u5b89\u5168\u6027\u4e8b\u4ef6\u7684\u80cc\u666f\u53d1\u751f\u7387\u3002\u5e94\u5c3d\u53ef\u80fd\u4ee5\u8868\u683c\u5f62\u5f0f\u5448\u73b0\uff0c\u5e76\u6309\u4e34\u5e8a\u8bd5\u9a8c\u3001\u4e0a\u5e02\u540e\u7ecf\u9a8c\u5206\u522b\u8bf4\u660e\u3002\u5bf9\u4e8e\u5728\u7814\u836f\u7269\uff0c\u9700\u63d0\u4f9b\u81eaDIBD\u8d77\u7d2f\u8ba1\u66b4\u9732\u4e8e\u8bd5\u9a8c\u836f\u3001\u5b89\u6170\u5242\u6216\u5bf9\u7167\u836f\u7684\u53d7\u8bd5\u8005\u6570\u91cf\uff0c\u5e76\u6309\u5e74\u9f84\u3001\u6027\u522b\u3001\u79cd\u65cf\u7b49\u5206\u7ec4\u3002\u6839\u636e\u66b4\u9732\u65f6\u95f4\u957f\u77ed\u4e0d\u540c\uff0c\u63a8\u8350\u4f7f\u7528\u201c\u53d7\u8bd5\u8005-\u65f6\u95f4\u201d\uff08\u53d7\u8bd5\u8005\u00b7\u5929\uff0c\u00b7\u6708\u6216\u00b7\u5e74\uff09\u4e3a\u5355\u4f4d\u3002<\/p>\n\n\n\n

                                  5. \u201c\u533a\u57df\u7279\u6709\u4fe1\u606f\u201d\u9644\u4ef6\u5177\u4f53\u6307\u4ec0\u4e48\uff1f<\/strong><\/p>\n\n\n\n

                                    <\/ol>\n\n\n\n

                                    \u8fd9\u662f\u4e2d\u56fd\u76d1\u7ba1\u7684\u7279\u8272\u8981\u6c42\uff0c\u5fc5\u987b\u5305\u542b\u5728DSUR\u4e2d\u3002\u4e3b\u8981\u9644\u4ef6\u901a\u5e38\u6709\uff1a<\/p>\n\n\n\n

                                      \n
                                    • \u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u7684\u7d2f\u8ba1\u6c47\u603b\u8868\uff08\u4e2d\u56fd\u5730\u533a\uff09\u3002<\/li>\n\n\n\n
                                    • \u62a5\u544a\u5468\u671f\u5185\u6b7b\u4ea1\u53d7\u8bd5\u8005\u5217\u8868\uff08\u4e2d\u56fd\u5730\u533a\uff09\u3002<\/li>\n\n\n\n
                                    • \u62a5\u544a\u5468\u671f\u5185\u56e0\u4efb\u4f55\u4e0d\u826f\u4e8b\u4ef6\u800c\u9000\u51fa\u7814\u7a76\u7684\u53d7\u8bd5\u8005\u5217\u8868\uff08\u4e2d\u56fd\u5730\u533a\uff09\u3002<\/li>\n\n\n\n
                                    • \u62a5\u544a\u5468\u671f\u5185\u53d1\u751f\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u53d8\u66f4\u6216\u8005\u4e34\u5e8a\u65b9\u9762\u7684\u65b0\u53d1\u73b0\u3001\u975e\u4e34\u5e8a\u6216\u8005\u836f\u5b66\u7684\u53d8\u5316\u6216\u8005\u65b0\u53d1\u73b0\u603b\u7ed3\u8868\uff08\u6b64\u8868\u9700\u533a\u5206\u201c\u53ef\u80fd\u589e\u52a0\u98ce\u9669\u9700\u8865\u5145\u7533\u8bf7\u201d\u548c\u201c\u8bc4\u4f30\u4e0d\u5f71\u54cd\u5b89\u5168\u53ef\u76f4\u63a5\u5728DSUR\u4e2d\u62a5\u544a\u201d\u4e24\u7c7b\u60c5\u51b5\uff09<\/li>\n\n\n\n
                                    • \u91cd\u5927\u751f\u4ea7\u53d8\u66f4\u4fe1\u606f\u3002<\/li>\n\n\n\n
                                    • \u4e0b\u4e00\u5e74\u5ea6\u603b\u4f53\u7814\u7a76\u8ba1\u5212\u6982\u8981\u7b49\u3002<\/li>\n<\/ul>\n\n\n\n

                                      \u4e09\u3001 \u7ed9\u4e34\u7814\u4ece\u4e1a\u8005\u7684\u6838\u5fc3\u5efa\u8bae<\/strong><\/strong><\/h1>\n\n\n\n
                                        \n
                                      1. \u5efa\u7acb\u5168\u5c40\u89c6\u91ce\uff1a<\/strong>\u7406\u89e3DSUR\u201c\u540c\u4e00\u6d3b\u6027\u6210\u5206\u4e00\u4efd\u62a5\u544a\u201d\u548c\u201c\u6570\u636e\u5168\u8986\u76d6\u201d\u7684\u539f\u5219\uff0c\u8981\u6c42\u9879\u76ee\u7ba1\u7406\u8005\u3001\u533b\u5b66\u548cPV\u4e13\u5458\u4e0d\u80fd\u53ea\u5173\u6ce8\u5355\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5fc5\u987b\u5efa\u7acb\u836f\u7269\u7814\u53d1\u9879\u76ee\u7684\u5168\u5c40\u89c2\uff0c\u786e\u4fdd\u8de8\u8bd5\u9a8c\u3001\u8de8\u533a\u57df\u7684\u5b89\u5168\u6027\u4fe1\u606f\u88ab\u6709\u6548\u6536\u96c6\u548c\u6574\u5408\u3002<\/li>\n\n\n\n
                                      2. \u5f3a\u5316\u8de8\u90e8\u95e8\u534f\u4f5c\uff1a<\/strong>DSUR\u7684\u64b0\u5199\u662f\u68c0\u6d4b\u7533\u529e\u8005PV\u4f53\u7cfb\u7684\u8bd5\u91d1\u77f3\uff0c\u5b83\u6d89\u53ca\u836f\u7269\u8b66\u6212\u3001\u4e34\u5e8a\u8fd0\u8425\u3001\u533b\u5b66\u3001\u6ce8\u518c\u3001\u975e\u4e34\u5e8a\u7814\u7a76\u7b49\u591a\u4e2a\u90e8\u95e8\u3002\u9ad8\u6548\u7684SOP\u3001\u6e05\u6670\u7684\u804c\u8d23\u754c\u5b9a\u4ee5\u53ca\u5b9e\u4e8b\u6c42\u662f\u7684\u98ce\u9669\u8bc4\u4f30\uff0c\u662f\u4ea7\u51fa\u9ad8\u8d28\u91cfDSUR\u7684\u57fa\u7840\u3002<\/li>\n\n\n\n
                                      3. \u7cbe\u901a\u6cd5\u89c4\u4e0e\u6307\u5357\uff1a<\/strong>\u4ece\u4e1a\u8005\u9700\u6301\u7eed\u5b66\u4e60ICH E2F\u6307\u5357\u3001\u4e2d\u56fdGVP\u89c4\u8303\u53caCDE\u7684\u6700\u65b0\u95ee\u7b54\u6587\u4ef6\u3002\u6e05\u6670\u638c\u63e1DIBD\u8ba1\u7b97\u3001\u9012\u4ea4\u65f6\u9650\u3001\u8303\u56f4\u754c\u5b9a\u7b49\u7ec6\u8282\uff0c\u662f\u907f\u514d\u5408\u89c4\u98ce\u9669\u7684\u524d\u63d0\u3002<\/li>\n\n\n\n
                                      4. \u7406\u89e3\u76d1\u7ba1\u610f\u56fe\uff1a<\/strong>DSUR\u4e0d\u4ec5\u662f\u5e74\u5ea6\u4efb\u52a1\uff0c\u66f4\u662f\u4e0e\u76d1\u7ba1\u673a\u6784\u5c31\u836f\u7269\u5b89\u5168\u6027\u8fdb\u884c\u6301\u7eed\u6c9f\u901a\u7684\u91cd\u8981\u6e20\u9053\u3002\u901a\u8fc7DSUR\uff0c\u7533\u529e\u8005\u5e94\u4e3b\u52a8\u5c55\u793a\u5176\u5bf9\u98ce\u9669\u7684\u6709\u6548\u76d1\u6d4b\u548c\u7ba1\u7406\u80fd\u529b\uff0c\u5efa\u7acb\u4fe1\u4efb\u3002<\/li>\n<\/ol>\n\n\n\n

                                        \u603b\u7ed3<\/strong>\uff1aDSUR\u7684\u7cbe\u9ad3\uff0c\u59cb\u4e8e\u300a\u7ba1\u7406\u89c4\u8303\u300b\u642d\u5efa\u7684\u521a\u6027\u6846\u67b6\uff0c\u6210\u4e8e\u4f01\u4e1a\u57fa\u4e8e\u95ee\u7b54\u6307\u5f15\u7684\u67d4\u6027\u5b9e\u8df5\u3002\u5b83\u8981\u6c42\u6211\u4eec\u65e2\u8981\u6709\u606a\u5b88\u89c4\u5219\u7684\u4e25\u8c28\uff0c\u4e5f\u8981\u6709\u878d\u4f1a\u8d2f\u901a\u7684\u667a\u6167\u3002\u5e0c\u671b\u8fd9\u4efd\u7ed3\u5408\u4e86\u6846\u67b6\u4e0e\u7ec6\u8282\u7684\u6307\u5357\uff0c\u80fd\u5e2e\u52a9\u60a8\u5728\u5b88\u62a4\u53d7\u8bd5\u8005\u5b89\u5168\u4e0e\u836f\u7269\u7814\u53d1\u5408\u89c4\u7684\u9053\u8def\u4e0a\uff0c\u8d70\u5f97\u66f4\u52a0\u7a33\u5065\u3001\u81ea\u4fe1\u3002<\/p>\n\n\n\n

                                        \u53c2\u8003\u6587\u732e<\/strong><\/p>\n\n\n\n

                                          \n
                                        1. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE). \u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\u7684\u95ee\u7b54\u6587\u4ef6: 2026\u5e74\u7b2c19\u53f7\u901a\u544a [EB\/OL]. (2026-02-24).<\/li>\n\n\n\n
                                        2. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE). \u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\u8d77\u8349\u8bf4\u660e [EB\/OL]. (2025-09-17).<\/li>\n\n\n\n
                                        3. ICH. E2F: Development Safety Update Report (DSUR) [S]. 2010-08-17.<\/li>\n\n\n\n
                                        4. \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3(CDE). \u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\u7ba1\u7406\u89c4\u8303(\u8bd5\u884c): 2020\u5e74\u7b2c7\u53f7\u901a\u544a [EB\/OL].<\/li>\n\n\n\n
                                        5. \u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u7f51. ICH\u57fa\u7840\u77e5\u8bc6500\u95ee_E2F\u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a [EB\/OL]. (2021-12-20).<\/li>\n\n\n\n
                                        6. \u7cbe\u8bda\u533b\u5b66\u60c5\u62a5\u4e2d\u5fc3\u901a\u8baf. \u7b2c10\u671f [J]. 2019-09-05.<\/li>\n\n\n\n
                                        7. \u4e2d\u56fd\u533b\u836f\u62a5. ICH\u57fa\u7840\u77e5\u8bc6500\u95ee_E2F\u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a [EB\/OL]. (2024-09-12).<\/li>\n<\/ol>\n\n\n\n
                                          <\/div>\n\n\n\n

                                          \u64b0\u7a3f\u4eba\uff1a\u674e\u6653\u5b87<\/p>\n\n\n\n

                                          \u5ba1\u6838\uff1a\u9648\u4e9a\u7ea2<\/p>\n\n\n\n

                                          \u6392\u7248\uff1a\u5468\u5b89\u6960<\/p>\n\n\n\n

                                          <\/p>\n","protected":false},"excerpt":{"rendered":"

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                                          \n\ud83d\udca1\u4e00\u4efd\u6307\u5357\uff0c\u5398\u6e05DSUR\u7684\u4e09\u4e2a\u6838\u5fc3\u95ee\u9898\uff1a\u57fa\u7840\u6846\u67b6\u662f\u4ec0\u4e48\uff1f \u6700\u65b0\u8981\u6c42\u6709\u54ea\u4e9b\uff1f\u5177\u4f53\u64cd\u4f5c\u5982\u4f55\u843d\u5730\uff1f<\/p>\n","protected":false},"author":1,"featured_media":1711,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[114,112,44,35,43,86,15,32,34,113],"class_list":["post-1709","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-cde","tag-dsur","tag-44","tag-35","tag-43","tag-86","tag-15","tag-32","tag-34","tag-113"],"_links":{"self":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1709","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1709"}],"version-history":[{"count":1,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1709\/revisions"}],"predecessor-version":[{"id":1716,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/posts\/1709\/revisions\/1716"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=\/wp\/v2\/media\/1711"}],"wp:attachment":[{"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1709"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1709"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.millibuff.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1709"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}