{"id":1247,"date":"2023-04-21T16:37:14","date_gmt":"2023-04-21T08:37:14","guid":{"rendered":"http:\/\/yunjiamed.cn\/?post_type=news&p=1247"},"modified":"2023-04-21T16:38:04","modified_gmt":"2023-04-21T08:38:04","slug":"https-mp-weixin-qq-com-s-ss0dselw1dhf_p37fij3ta","status":"publish","type":"news","link":"http:\/\/yunjiamed.cn\/news\/https-mp-weixin-qq-com-s-ss0dselw1dhf_p37fij3ta\/","title":{"rendered":"\u836f\u5ba1\u4e2d\u5fc3\uff08CDE\uff09\u8fd12\u5e74\u6280\u672f\u7b54\u7591\u6c47\u603b\u89e3\u6790"},"content":{"rendered":"\n

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

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

01<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u5728\u5ba1\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u7ecf\u6280\u672f\u5ba1\u8bc4\u8ba4\u4e3a\u9700\u8981\u8fdb\u884c\u836f\u54c1\u901a\u7528\u540d\u6838\u5b9a\u7684\uff0c\u7531\u836f\u5ba1\u4e2d\u5fc3\u63d0\u51fa\u5e76\u4ee5\u53d1\u8865\u6216\u53d1\u51fd\u65b9\u5f0f\u901a\u77e5\u7533\u8bf7\u4eba\u8fdb\u884c\u836f\u54c1\u901a\u7528\u540d\u6838\u5b9a\u3002\u7533\u8bf7\u4eba\u4e5f\u53ef\u81f4\u51fd\u836f\u5ba1\u4e2d\u5fc3\uff0c\u63d0\u51fa\u901a\u7528\u540d\u6838\u5b9a\u7533\u8bf7\u3002<\/p>\n\n\n\n

02<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u5173\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7528\u751f\u7269\u5236\u54c1\u53c2\u7167\u836f\u54c1\u4e00\u6b21\u6027\u8fdb\u53e3\u6709\u5173\u4e8b\u5b9c\u7684\u516c\u544a\u300b\uff082018 \u5e74\u7b2c 94 \u53f7\uff09\u7b26\u5408\u4ee5\u4e0b\u6761\u4ef6\u3001\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u53c2\u7167\u836f\u7684\u751f\u7269\u5236\u54c1\uff0c\u53ef\u4e88\u4ee5\u4e00\u6b21\u6027\u8fdb\u53e3\u3002<\/p>\n\n\n\n

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03<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u8003\u8651\u5230\u4e0a\u8ff0\u5355\u836f\u5747\u672a\u4e0a\u5e02\uff0c\u5e94\u5206\u522b\u6309\u7167\u65b0\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u7533\u62a5\uff0c\u5e76\u4e92\u76f8\u5173\u8054\u3002\u5982\u6b64\u6b21\u7533\u8bf7\u4e0e\u5355\u836f\u7533\u8bf7\u91cd\u590d\u7684\u836f\u5b66\u8d44\u6599\u53ef\u514d\u4e8e\u63d0\u4ea4\uff08\u4f46\u4e34\u5e8a\u6df7\u5408\u7528\u836f\u7684\u60c5\u51b5\u9664\u5916\uff09\u3002\u4f46\u8054\u5408\u7528\u836f\u836f\u7406\u6bd2\u7406\u8bc4\u4ef7\u9700\u7ed3\u5408\u5355\u836f\u7814\u7a76\u6570\u636e\u8fdb\u884c\u5206\u6790\u3002\u56e0\u6b64\uff0c\u836f\u7406\u6bd2\u7406\u90e8\u5206\u8d44\u6599\u5e94\u6309\u8981\u6c42\u63d0\u4ea4\u3002<\/p>\n\n\n\n

04<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u5883\u5916\u5df2\u4e0a\u5e02\u7684\u6cbb\u7597\u827e\u6ecb\u75c5\u7684\u65b0\u836f\u53ef\u4ee5\u6309\u7167\u300a\u5173\u4e8e\u4f18\u5316\u836f\u54c1\u6ce8\u518c\u5ba1\u8bc4\u5ba1\u6279\u6709\u5173\u4e8b\u5b9c\u516c\u544a\u300b\uff082018\u5e74\u7b2c23\u53f7\uff09\u7b2c\u4e8c\u5929\u7684\u8981\u6c42\u8fdb\u884c\u5ba1\u8bc4\u548c\u53d7\u7406\uff0c\u7533\u8bf7\u4eba\u7ecf\u7814\u7a76\u8ba4\u4e3a\u4e0d\u5b58\u5728\u4eba\u79cd\u5dee\u5f02\uff0c\u53ef\u4ee5\u63d0\u4ea4\u5883\u5916\u53d6\u5f97\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u76f4\u63a5\u7533\u62a5\u54c1\u4e0a\u5e02\u6ce8\u518c\u7533\u8bf7\u3002<\/p>\n\n\n\n

05<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u975e\u751f\u7269\u5236\u54c11\u7c7b\u6ce8\u518c\u7533\u8bf7\uff0c\u5e94\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u5c40\u4ee4\u7b2c28\u53f7\uff09\u9644\u4ef63\u8981\u6c42\uff0c\u6cbb\u7597\u7528\u751f\u7269\u5236\u54c1\u5b8c\u6210\u4e34\u5e8a\u8bd5\u9a8c\u540e\u62a5\u9001\u8d44\u6599\u9879\u76ee1-6\u300115\u548c29-38\uff0c\u9884\u9632\u7528\u751f\u7269\u5236\u54c1\u5b8c\u6210\u4e34\u5e8a\u8bd5\u9a8c\u540e\u62a5\u9001\u8d44\u6599\u9879\u76ee1\u30012\u548c12-18\u3002\u5bf9\u4e8e\u751f\u7269\u5236\u54c11\u7c7b\u6ce8\u518c\u7533\u8bf7\uff0c\u5e94\u6309\u7167\u300a\u5173\u4e8e\u9002\u7528\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u7684\u516c\u544a\u300b\uff082018\u5e74\u7b2c10\u53f7\uff09\u76f8\u5173\u8981\u6c42\u8fdb\u884c\u63d0\u4ea4\u3002<\/p>\n\n\n\n

06<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff0c\u5168\u90e8\u7533\u62a5\u8d44\u6599\u5e94\u5f53\u4f7f\u7528\u4e2d\u6587\u5e76\u9644\u539f\u6587\uff0c\u5176\u4ed6\u6587\u79cd\u7684\u8d44\u6599\u53ef\u9644\u540e\u4f5c\u4e3a\u53c2\u8003\u3002\u4e2d\u6587\u8bd1\u6587\u5e94\u5f53\u4e0e\u539f\u6587\u4e00\u81f4\u3002<\/p>\n\n\n\n

07<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u5728\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u5ba1\u8bc4\u5ba1\u6279\u8fc7\u7a0b\u4e2d\uff0c\u7533\u8bf7\u4eba\u673a\u6784\u540d\u79f0\u53d1\u751f\u7684\u53d8\u66f4\uff0c\u53ef\u6309\u4ee5\u4e0b\u4e0d\u540c\u60c5\u51b5\u5206\u522b\u5904\u7406\u3002  <\/p>\n\n\n\n

\uff08\u4e00\uff09\u5982\u7533\u8bf7\u4eba\u4e3b\u4f53\u4e0d\u53d8\uff0c\u6309\u7167\u603b\u5c40\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff08\u98df\u836f\u76d1\u836f\u5316\u7ba1\u30142015\u3015122\u53f7\uff09\u7684\u8981\u6c42\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u63d0\u4ea4\u516c\u6587\u65b9\u5f0f\u5411\u8be5\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u7684\u53d7\u7406\u90e8\u95e8\u63d0\u51fa\u53d8\u66f4\u7533\u8bf7\uff0c\u7531\u76f8\u5e94\u53d7\u7406\u90e8\u95e8\u5ba1\u6838\u5904\u7406\uff08\u5982\u539f\u7701\u5c40\u53d7\u7406\u7684\u7531\u7701\u5c40\u62a5\u836f\u5ba1\u4e2d\u5fc3\u4fee\u6539\u7533\u8bf7\u4fe1\u606f\uff1b\u5982\u7531\u836f\u5ba1\u4e2d\u5fc3\u53d7\u7406\u7684\uff0c\u836f\u5ba1\u4e2d\u5fc3\u5ba1\u6838\u540e\u76f4\u63a5\u4fee\u6539\u7533\u8bf7\u4fe1\u606f\uff09\u3002  <\/p>\n\n\n\n

\uff08\u4e8c\uff09\u5982\u7533\u8bf7\u4eba\u4e3b\u4f53\u53d1\u751f\u53d8\u66f4\uff0c\u4f46\u4e0d\u6d89\u53ca\u6280\u672f\u53d8\u5316\uff08\u5982\u5b9e\u9645\u751f\u4ea7\u5730\u5740\u4e0d\u53d8\uff09\u3002\u53c2\u7167\u4e0a\u8ff0\u201c\uff08\u4e00\uff09\u201d\u529e\u7406\u3002<\/p>\n\n\n\n

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08<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6b64\u7c7b\u60c5\u51b5\uff0c\u8003\u8651\u5230\u8be5\u54c1\u79cd\u5df2\u6709\u4e2d\u56fd\u4eba\u7684\u5b8c\u6574\u548c\u5145\u5206\u7684\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u6570\u636e\u4f5c\u53c2\u8003\uff0c\u53ef\u6309\u5316\u5b66\u836f\u54c1\u65b04\u7c7b\u8fdb\u884c\u7533\u62a5\u3002<\/p>\n\n\n\n

09<\/strong><\/p>\n\n\n\n

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I\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u5173\u4e8e\u8c03\u6574\u8fdb\u53e3\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u6709\u5173\u4e8b\u9879\u7684\u51b3\u5b9a\u300b\u30142017\u301535\u53f7\uff0c\u5728\u4e2d\u56fd\u8fdb\u884c\u56fd\u9645\u591a\u4e2d\u5fc3\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5141\u8bb8\u540c\u6b65\u5f00\u5c55I\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u53d6\u6d88\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269\u5e94\u5f53\u5df2\u5728\u5883\u5916\u6ce8\u518c\uff0c\u6216\u8005\u5df2\u8fdb\u5165\u2161\u671f\u6216\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8981\u6c42\uff0c\u9884\u9632\u7528\u751f\u7269\u5236\u54c1\u9664\u5916\u3002<\/p>\n\n\n\n

10<\/strong><\/p>\n\n\n\n

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\u6587\u6863\uff08CTD\uff09\u300b\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u4e5f\u53ef\u9002\u7528\u300aM4\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09\u300b\u3002<\/p>\n\n\n\n

11<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u4f9d\u636e\u300a\u5173\u4e8e\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u6ce8\u518c\u6709\u5173\u4e8b\u5b9c\u7684\u901a\u544a\u300b\u30142009\u301516\u53f7\uff0c\u7533\u8bf7\u4eba\u6839\u636e\u4ea7\u54c1\u5c5e\u6027\u5ba1\u5b9a\u610f\u89c1\uff0c\u4ee5\u836f\u54c1\u4f5c\u7528\u4e3a\u4e3b\u7684\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\uff0c\u9700\u7533\u62a5\u836f\u54c1\u6ce8\u518c\uff0c\u5e76\u5728\u7533\u8bf7\u8868\u4e2d\u6ce8\u660e\u201c\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u201d\u3002\u540c\u65f6\uff0c\u9700\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u3001\u300a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u7b49\u76f8\u5173\u6cd5\u5f8b\u6cd5\u89c4\u63d0\u4ea4\u7533\u62a5\u8d44\u6599\u3002<\/p>\n\n\n\n

12<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5bf9\u4e8e\u8fdb\u53e3\u836f\u54c1\u518d\u6ce8\u518c\u7533\u8bf7\uff0c\u80fd\u5426\u540c\u65f6\u7533\u62a5\u589e\u52a0\u836f\u54c1\u89c4\u683c\u7684\u53d8\u66f4\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6b64\u7c7b\u60c5\u5f62\u4e0d\u80fd\u540c\u65f6\u7533\u62a5\u3002\u6309\u7167\u300a\u5173\u4e8e\u8fdb\u53e3\u836f\u54c1\u518d\u6ce8\u518c\u6709\u5173\u4e8b\u9879\u7684\u516c\u544a\u300b[2009]\u7b2c18\u53f7\uff0c\u8fdb\u53e3\u836f\u54c1\u518d\u6ce8\u518c\u4e0d\u5e94\u540c\u65f6\u7533\u62a5\u6539\u6362\u4ea7\u5730\u3001\u589e\u52a0\u836f\u54c1\u89c4\u683c\u7684\u8865\u5145\u7533\u8bf7\uff0c\u6539\u6362\u4ea7\u5730\u3001\u589e\u52a0\u836f\u54c1\u89c4\u683c\u5fc5\u987b\u6309\u7167\u8865\u5145\u7533\u8bf7\u7684\u7a0b\u5e8f\u5355\u72ec\u7533\u62a5\u3002<\/p>\n\n\n\n

13<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u53d8\u66f4\u8fdb\u53e3\u836f\u54c1\u7684\u6ce8\u518c\u4ee3\u7406\u673a\u6784\u5982\u4f55\u7533\u62a5\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u5173\u4e8e\u8fdb\u53e3\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u6709\u5173\u95ee\u9898\u7684\u516c\u544a\u300b\u30142015\u3015162\u53f7\uff0c\u6539\u53d8\u8fdb\u53e3\u836f\u54c1\u7684\u6ce8\u518c\u4ee3\u7406\u673a\u6784\uff0c\u5c5e\u4e8e\u8865\u5145\u7533\u8bf7\u7b2c28\u9879\uff0c\u5e94\u7533\u62a5\u5907\u6848\u7533\u8bf7\u3002<\/p>\n\n\n\n

14<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u53d7\u7406\u901a\u77e5\u4e66\u3001\u8865\u6b63\u901a\u77e5\u4e66\u3001\u7f34\u8d39\u901a\u77e5\u4e66\u7b49\u80fd\u5426\u6309\u7167\u7533\u8bf7\u8868\/\u767b\u8bb0\u8868\u4e2d\u7684\u901a\u8baf\u5730\u5740\u90ae\u5bc4\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u76ee\u524d\uff0c\u53d7\u7406\u901a\u77e5\u4e66\u7b49\u5747\u90ae\u5bc4\u5230\u7533\u8bf7\u8868\/\u767b\u8bb0\u8868\u4e2d\u7684\u6ce8\u518c\u5730\u5740\u3002\u5982\u7533\u8bf7\u4eba\u62df\u6309\u901a\u8baf\u5730\u5740\u6216\u5176\u4ed6\u5730\u5740\u63a5\u6536\u4e0a\u8ff0\u8d44\u6599\uff0c\u8bf7\u5728\u7533\u8bf7\u8868\/\u767b\u8bb0\u8868\u7684\u201c\u5176\u4ed6\u7279\u522b\u7533\u660e\u4e8b\u9879\u201d\u4e2d\u4e88\u4ee5\u6ce8\u660e\u3002<\/p>\n\n\n\n

15<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5df2\u83b7\u5f97I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\uff0c\u73b0\u5df2\u5b8c\u6210\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u540e\u7eed\u5982\u4f55\u7533\u62a5\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u8865\u5145\u7533\u8bf7\u65b9\u5f0f\u7533\u8bf7\u540e\u7eed\u2161\u3001\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

16<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u300a\u5173\u4e8e\u8c03\u6574\u8fdb\u53e3\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u6709\u5173\u4e8b\u9879\u7684\u51b3\u5b9a\u300b\uff08\u56fd\u9645\u98df\u54c1\u836f\u54c1<\/strong><\/p>\n\n\n\n

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\u51fa\u514d\u505a\u8fdb\u53e3\u836f\u54c1\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u7b26\u5408\u89c4\u5b9a\u7684\u53ef\u4ee5\u76f4\u63a5\u6279\u51c6\u8fdb<\/strong><\/p>\n\n\n\n

\u53e3\u201d  \u3002\u7533\u8bf7\u4eba\u5e94\u5728\u4ec0\u4e48\u65f6\u5019\u63d0\u4ea4\u8be5\u54c1\u79cd\u6838\u5b9a\u836f\u54c1\u901a\u7528\u540d\u7684\u7533\u8bf7\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5bf9\u5c5e\u4e8e35\u53f7\u4ee4\u89c4\u5b9a\u7684\u8fc7\u6e21\u671f\u60c5\u5f62\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u7533\u8bf7\u4eba\u53ef\u5728\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u4ee5\u516c\u6587\u65b9\u5f0f\u5411\u6211\u4e2d\u5fc3\u63d0\u51fa\u7533\u8bf7\uff0c\u6211\u4e2d\u5fc3\u5c06\u6309\u7a0b\u5e8f\u8f6c\u7531\u56fd\u5bb6\u836f\u5178\u59d4\u6838\u5b9a\u901a\u7528\u540d\u3002<\/p>\n\n\n\n

17<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5bf9\u4e8eFDA\u6279\u51c6\u7684\u65b0\u5242\u578b\u4ea7\u54c1\uff08505b2\u9014\u5f84\uff09\uff0c\u4e14\u6a59\u76ae\u4e66\u663e\u793a\u8be5<\/strong><\/p>\n\n\n\n

\u4ea7\u54c1\u4e3aRLD\u548cRS\uff0c\u5982\u7533\u8bf7\u8fdb\u53e3\u6ce8\u518c\uff0c\u5e94\u63095.1\u8fd8\u662f5.2\u7c7b\u7533\u62a5\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u5f53\u524d\u6cd5\u89c4\uff0c\u6b64\u7c7b\u60c5\u5f62\u53ef\u63095.1\u7c7b\u8fdb\u884c\u7533\u62a5\u3002<\/p>\n\n\n\n

18<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6539\u53d8\u8fdb\u53e3\u836f\u54c1\u5236\u5242\u6240\u7528\u539f\u6599\u836f\u7684\u4ea7\u5730\uff0c\u5e94\u6309\u4f55\u79cd\u4e8b\u9879\u7533\u62a5\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5236\u5242\u53d8\u66f4\u539f\u6599\u836f\u4ea7\u5730\uff0c\u53ef\u80fd\u5bf9\u5236\u5242\u7684\u8d28\u91cf\u9020\u6210\u4e00\u5b9a\u5f71\u54cd\uff0c\u5efa\u8bae\u6309\u9700\u6280\u672f\u5ba1\u8bc4\u7684\u8865\u5145\u7533\u8bf7\u8fdb\u884c\u7533\u62a5\u3002<\/p>\n\n\n\n

19<\/strong><\/p>\n\n\n\n

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\u4e8e\u51e0\u7c7b\u53d8\u66f4\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u5e72\u71e5\u65b9\u5f0f\u7531\u76d8\u5f0f\u5e72\u71e5\u53d8\u4e3a\u6d41\u5316\u5e8a\u5e72\u71e5\uff0c\u5bf9\u4ea7\u54c1\u8d28\u91cf\u53ef\u80fd\u4ea7\u751f\u663e\u8457\u5f71\u54cd\uff0c\u6839\u636e\u300a\u5df2\u4e0a\u5e02\u5316\u5b66\u836f\u54c1\u53d8\u66f4\u7814\u7a76\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff0c\u5c5e\u4e8e\u2162\u7c7b\u53d8\u66f4\u3002\u4e14\u5e72\u71e5\u65b9\u5f0f\u7684\u53d8\u66f4\u53ef\u80fd\u5f71\u54cd\u4ea7\u54c1\u7684\u751f\u7269\u5229\u7528\u5ea6\uff0c\u96be\u6eb6\u6027\u56fa\u4f53\u53e3\u670d\u5236\u5242\uff0c\u6839\u636e\u73b0\u884c\u6280\u672f\u8981\u6c42\uff0c\u9700\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7814\u7a76\u3002<\/p>\n\n\n\n

20<\/strong><\/p>\n\n\n\n

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\u5df2\u4e0a\u5e02\u4ea7\u54c1\u5747\u6700\u7ec8\u91c7\u7528\u98df\u87f9\u7334\u4f5c\u4e3a\u5176\u6b63\u5f0f\u957f\u6bd2\u5b9e\u9a8c\u7684\u52a8\u7269\u79cd\u5c5e\u3002  <\/strong><\/p>\n\n\n\n

\u53ef\u5426\u53ea\u9009\u62e9\u98df\u87f9\u7334\u4e00\u4e2a\u76f8\u5173\u79cd\u5c5e\u8fdb\u884c\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u8bc4\u4ef7\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u65b0\u5355\u6297\u7684\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u8bc4\u4ef7\u9700\u8003\u8651\u52a8\u7269\u79cd\u5c5e\u9009\u62e9\u95ee\u9898\uff0c\u53ef\u9009\u62e9\u76f8\u5173\u52a8\u7269\u79cd\u5c5e\u5f00\u5c55\u4e34\u5e8a\u524d\u7814\u7a76\u3002\u82e5\u4ec5\u6709\u4e00\u79cd\u65f6\u53ef\u9009\u62e9\u4e00\u79cd\u52a8\u7269\u79cd\u5c5e\u5f00\u5c55\u540e\u7eed\u957f\u671f\u7684\u91cd\u590d\u7ed9\u836f\u6bd2\u6027\u8bd5\u9a8c\uff0c\u4f46\u5efa\u8bae\u5728\u65e9\u671f\u5242\u91cf\u63a2\u7d22\u6bd2\u6027\u8bd5\u9a8c\u4e2d\u5305\u62ec\u7b2c\u4e8c\u79cd\u52a8\u7269\u79cd\u5c5e\u7684\u6bd2\u6027\u7814\u7a76\uff0c\u4ee5\u786e\u5b9a\u6bd2\u6027\uff0c\u5bf9\u8131\u9776\u6bd2\u6027\u98ce\u9669\u8bc4\u4ef7\u662f\u6709\u610f\u4e49\u7684\u3002<\/p>\n\n\n\n

21<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6ce8\u5c04\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u54c1\u79cd\u662f\u5426\u9700\u8981\u5f00\u5c55\u8fc7\u654f\u3001\u523a\u6fc0\u3001\u6eb6\u8840\u8bd5\u9a8c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u82e5\u5904\u65b9\u5de5\u827a\u53d1\u751f\u53d8\u66f4\u7684\u9700\u8fdb\u884c\u7814\u7a76\uff0c\u5982\u5df2\u6709\u4e34\u5e8a\u5b89\u5168\u6027\u6570\u636e\u7684\u53ef\u4e0d\u8981\u6c42\u3002<\/p>\n\n\n\n

22<\/strong><\/p>\n\n\n\n

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\u6837<\/strong>\u54c1\u60c5\u51b5\u3001\u8003\u5bdf\u6761\u4ef6\u3001\u8003\u5bdf\u6307\u6807\u548c\u8003\u5bdf\u7ed3\u679c\uff0c\u5bf9\u53d8\u5316\u8d8b\u52bf\u8fdb\u884c\u5206<\/strong><\/p>\n\n\n\n

\u6790\uff0c<\/strong>\u63d0\u51fa\u8d2e\u5b58\u6761\u4ef6\u548c\u6709\u6548\u671f\uff0c\u5e76\u4e0e\u539f\u7814\u836f\u53ca\u836f\u5178\u6536\u8f7d\u7684\u540c\u54c1\u79cd\u7684<\/strong><\/p>\n\n\n\n

\u8981\u6c42<\/strong>\u8fdb\u884c\u6bd4\u8f83\uff0c\u4eff\u5236\u836f\u7684\u7a33\u5b9a\u6027\u4e0d\u5f97\u66f4\u5dee\u3002\u4f46\u901a\u5e38\u4eff\u5236\u4f01\u4e1a\u4e70\u5230<\/strong><\/p>\n\n\n\n

\u53c2\u6bd4<\/strong>\u5236\u5242\u65f6\u5df2\u7ecf\u8fc7\u4e86\u534a\u5e74\u591a\u6216\u4e00\u5e74\uff0c\u662f\u5426\u53ef\u4ee5\u4ee5\u751f\u4ea7\u65e5\u671f\u4e3a\u8d77\u59cb<\/strong><\/p>\n\n\n\n

\u70b9\u8fdb<\/strong>\u884c\u53c2\u6bd4\u5236\u5242\u540e\u7eed\u7684\u7a33\u5b9a\u6027\u7814\u7a76\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5efa\u8bae\u53c2\u7167\u7a33\u5b9a\u6027\u7814\u7a76\u6307\u5bfc\u539f\u5219\uff0c\u5bf9\u7533\u62a5\u4ea7\u54c1\u8fdb\u884c\u7a33\u5b9a\u6027\u7814\u7a76\u3002  \u5e76\u672a\u5f3a\u5236\u8981\u6c42\u4e00\u5b9a\u8981\u4e0e\u53c2\u6bd4\u5236\u5242\u8fdb\u884c\u7a33\u5b9a\u6027\u5bf9\u6bd4\u7814\u7a76\u3002<\/p>\n\n\n\n

23<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\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\uff0c\u5982\u679c\u53c2\u6bd4\u5236\u5242\u8bf4\u660e\u4e66\u4e2d\u660e\u786e\u8bf4\u660e\u8be5\u836f\u7269\u4ec5\u53ef\u7a7a\u8179\u670d\u7528\uff08\u996d\u524d1\u5c0f\u65f6\u6216\u996d\u540e2\u5c0f\u65f6\u670d\u7528\uff09\u65f6\uff0c\u5219\u53ef\u4e0d\u8fdb\u884c\u9910\u540e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002\u5bf9\u4e8e\u4ec5\u80fd\u4e0e\u98df\u7269\u540c\u670d\u7684\u53e3\u670d\u5e38\u91ca\u5236\u5242\uff0c\u9664\u4e86\u7a7a\u8179\u670d\u7528\u53ef\u80fd\u6709\u4e25\u91cd\u5b89\u5168\u6027\u65b9\u9762\u98ce\u9669\u7684\u60c5\u51b5\u5916\uff0c\u5747\u5efa\u8bae\u8fdb\u884c\u7a7a\u8179\u548c\u9910\u540e\u4e24\u79cd\u6761\u4ef6\u4e0b\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002\u5982\u6709\u8d44\u6599\u5145\u5206\u8bf4\u660e\u7a7a\u8179\u670d\u836f\u53ef\u80fd\u6709\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\uff0c\u5219\u4ec5\u9700\u8fdb\u884c\u9910\u540e\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002<\/p>\n\n\n\n

24<\/strong><\/p>\n\n\n\n

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FDA\u5141\u8bb8\u7528\u5c0f\u89c4\u683c\u5f00\u5c55BE\uff0c\u514d\u5927\u89c4\u683c\u7684BE\u3002\u5982\u7533\u8bf7\u4eff\u5236\u6b64\u4ea7<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\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\u8981\u6c42\uff0c\u82e5\u6700\u9ad8\u89c4\u683c\u6709\u5b89\u5168\u6027\u65b9\u9762\u98ce\u9669\uff0c\u5728\u540c\u65f6\u6ee1\u8db3\u5982\u4e0b\u6761\u4ef6\u7684\u60c5\u51b5\u4e0b\uff0c\u53ef\u91c7\u7528\u975e\u6700\u9ad8\u89c4\u683c\u7684\u5236\u5242\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff1a<\/p>\n\n\n\n

\uff08\u4e00\uff09\u5728\u6cbb\u7597\u5242\u91cf\u8303\u56f4\u5185\u5177\u6709\u7ebf\u6027\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u5f81\uff1b<\/p>\n\n\n\n

\uff08\u4e8c\uff09\u53d7\u8bd5\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u7684\u6700\u9ad8\u89c4\u683c\u4e0e\u5176\u8f83\u4f4e\u89c4\u683c\u7684\u5236\u5242\u5904\u65b9\u6bd4\u4f8b\u76f8\u4f3c\uff1b<\/p>\n\n\n\n

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25<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5bf9\u4e8eBCS\u5206\u7c7b\u4e0d\u660e\u786e\u836f\u7269\uff0c\u5982\u4f55\u7533\u8bf7\u8c41\u514d\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5efa\u8bae\u6e17\u900f\u6027\u6570\u636e\u4ee5\u4eba\u4f53\u6570\u636e\u4e3a\u51c6\uff0c\u82e5\u539f\u7814\u8bf4\u660e\u4e66\u6709\u76f8\u5173\u6570\u636e\uff0c\u53ef\u4ee5\u5f15\u7528\u3002\u4eba\u4f53\u6570\u636e\u4e0d\u5145\u5206\u7684\u60c5\u51b5\u4e0b\uff0c\u4f53\u5916\u6e17\u900f\u6027\u6570\u636e\u53ef\u4f5c\u4e3a\u652f\u6301\u6027\u6570\u636e\u3002<\/p>\n\n\n\n

26<\/strong><\/p>\n\n\n\n

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\u54ea\u4e9b\u7814\u7a76\u8d44\u6599\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5e94\u6839\u636e\u300a\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8c41\u514d\u6307\u5bfc\u539f\u5219\u300b\uff0c\u8bc1\u660e\u8fd9\u4e9b\u54c1\u79cd\u7684BCS\u5206\u7c7b\u3002\u5bf9\u4e8eBCS1\u7c7b\u7684\u54c1\u79cd\uff0c\u5e94\u8fdb\u884c\u6eb6\u89e3\u5ea6\u3001\u6eb6\u51fa\u5ea6\u548c\u6e17\u900f\u6027\u7814\u7a76\uff1b\u5bf9\u4e8eBCS3\u7c7b\u836f\u7269\uff0c\u9664\u9700\u8fdb\u884c\u6eb6\u89e3\u5ea6\u3001\u6eb6\u51fa\u5ea6\u7814\u7a76\u5916\uff0c\u8fd8\u5e94\u5904\u65b9\u79cd\u7c7b\u4e00\u81f4\uff0c\u5404\u7ec4\u6210\u7528\u91cf\u76f8\u4f3c\u3002\u7533\u8bf7\u4eba\u5e94\u6839\u636e\u54c1\u79cd\u7279\u70b9\u548c\u81ea\u8eab\u8d44\u6599\u6309\u8981\u6c42\u7533\u62a5\u3002<\/p>\n\n\n\n

27<\/strong><\/p>\n\n\n\n

\u95ee\uff1a2017\u5e74\u7b2c100\u53f7\u516c\u544a\u300a\u603b\u5c40\u5173\u4e8e\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u4f5c\u6709\u5173\u4e8b\u9879\u7684\u516c\u544a  \u300b\u7b2c\u516b\u6761\u89c4\u5b9a\uff1a\u5bf9\u4e0a\u5e02\u524d\u6309\u7167\u4e0e\u539f\u7814\u836f\u54c1\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u539f\u5219\u7533\u62a5\u548c\u5ba1\u8bc4\u7684\u54c1\u79cd\uff0c\u7533\u8bf7\u4eba\u5e94\u8bc4\u4f30\u662f\u5426\u6ee1\u8db3\u73b0\u884c\u4e00\u81f4\u6027\u8bc4\u4ef7\u6280\u672f\u6307\u5bfc\u539f\u5219\u8981\u6c42\u3002\u7ecf\u8bc4\u4f30\u8fbe\u5230\u8981\u6c42\u7684\uff0c\u7533\u8bf7\u4eba\u53ef\u5411\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u63d0\u51fa\u514d\u4e8e\u53c2\u52a0\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u7533\u8bf7\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5c06\u6309\u7167\u73b0\u884c\u4e00\u81f4\u6027\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\uff0c\u5bf9\u539f\u6ce8\u518c\u7533\u62a5\u8d44\u6599\u5ba1\u8bc4\uff0c\u91cd\u70b9\u5ba1\u6838\u5176\u771f\u5b9e\u6027\u548c\u5b8c\u6574\u6027\u3002\u7b26\u5408\u8be5\u6761\u7684\u5df2\u4e0a\u5e02\u6ce8\u5c04\u5242\uff0c\u901a\u8fc7\u4f55\u79cd\u9014\u5f84\u7533\u62a5\u514d\u4e8e\u4e00\u81f4\u6027\u8bc4\u4ef7\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u7533\u8bf7\u8c41\u514d\u8fdb\u884c\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\uff0c\u53ef\u6309\u8865\u5145\u7533\u8bf7\u8fdb\u884c\u7533\u62a5\u3002<\/p>\n\n\n\n

28<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u65b0\u6ce8\u518c\u5206\u7c7b\u65b0\u836f\uff0c\u672c\u8eab\u5177\u6709\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u8bc1\u636e\uff0c\u4e0d\u9700\u8981\u8fdb\u884c\u4e00\u81f4\u6027\u8bc4\u4ef7\uff0c\u4e0a\u5e02\u540e\u7eb3\u5165\u300a\u4e2d\u56fd\u4e0a\u5e02\u836f\u54c1\u76ee\u5f55\u96c6\u300b\uff1b\u5bf9\u65b0\u6ce8\u518c\u5206\u7c7b\u4eff\u5236\u836f\uff0c\u5df2\u6309\u7167\u4e0e\u539f\u7814\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u7684\u539f\u5219\u53d7\u7406\u548c\u5ba1\u8bc4\u5ba1\u6279\uff0c\u4e0d\u9700\u8981\u91cd\u590d\u8fdb\u884c\u4e00\u81f4\u6027\u8bc4\u4ef7\uff0c\u4e0a\u5e02\u540e\u7eb3\u5165\u300a\u4e2d\u56fd\u4e0a\u5e02\u836f\u54c1\u76ee\u5f55\u96c6\u300b\u3002<\/p>\n\n\n\n

29<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6839\u636e2015\u5e74\u7b2c257\u53f7\u5173\u4e8e\u5316\u5b66\u836f\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5b9e\u884c\u5907\u6848\u7ba1\u7406\u7684\u516c\u544a\uff0c\u5c5e\u4e8e\u9644\u4ef6\u4e2d\u7b2c\u4e00\u6761\uff08\u4e8c\uff09\u9879\u4e0b\u7684\u5316\u5b66\u836f\uff0c\u5982\u62df\u5f00\u5c55\u4e00\u81f4\u6027\u8bc4\u4ef7\uff0c\u5e94\u9996\u5148\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u7533\u62a5\u666e\u901a\u7684\u8865\u5145\u7533\u8bf7\uff0c\u5f85\u6279\u51c6\u540e\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\uff0c\u5b8c\u6210\u4e34\u5e8a\u7814\u7a76\u540e\u7533\u62a5\u4e00\u81f4\u6027\u8bc4\u4ef7\u3002<\/p>\n\n\n\n

30<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6b64\u7c7b\u53d8\u66f4\uff0c  \u5efa\u8bae\u6309\u7167\u53d8\u66f4\u5904\u65b9\u5de5\u827a\u7533\u62a5\u3002<\/p>\n\n\n\n

31<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u9009\u7528\u53c2\u6bd4\u5236\u5242\u4e0d\u5fc5\u4e0e\u603b\u5c40\u53d1\u5e03\u7684\u53c2\u6bd4\u5236\u5242\u5b8c\u5168\u4e00\u81f4\u3002\u7533\u8bf7\u4eba\u53ef\u6309\u7167\u603b\u5c40\u300a\u5df2\u53d1\u5e03\u53c2\u6bd4\u5236\u5242\u6709\u5173\u4e8b\u5b9c\u8bf4\u660e\u300b\uff082017\u5e748\u670818\u65e5\uff09\u9009\u62e9\u89c6\u4e3a\u7b49\u540c\u4ea7\u54c1\u4f5c\u4e3a\u53c2\u6bd4\u5236\u5242\u3002\u7533\u8bf7\u4eba\u5982\u6309\u4e0a\u8ff0\u539f\u5219\u96be\u4ee5\u5224\u65ad\u6216\u4e0d\u53ef\u89c6\u4e3a\u7b49\u540c\uff0c\u4f46\u6709\u9002\u5b9c\u7684\u8bc1\u636e\u8ba4\u4e3a\u53ef\u89c6\u4e3a\u7b49\u540c\u7684\uff0c\u53ef\u4ee5\u516c\u6587\u5f62\u5f0f\u5411\u4e00\u81f4\u529e\u63d0\u51fa\u56f0\u96be\u548c\u62df\u89e3\u51b3\u65b9\u5f0f\uff0c\u63d0\u4f9b\u8be6\u7ec6\u7684\u54c1\u79cd\u4fe1\u606f\u548c\u76f8\u5173\u8d44\u6599\uff0c\u4e00\u81f4\u529e\u5c06\u4e0e\u4f01\u4e1a\u5c31\u54c1\u79cd\u5177\u4f53\u60c5\u51b5\u4e88\u4ee5\u8ba8\u8bba\u3002<\/p>\n\n\n\n

32<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u53d6\u5f97BE\u4e34\u5e8a\u6279\u4ef6\u540e\uff0c\u5982\u53d1\u751f\u5de5\u827a\u53d8\u66f4\uff0c\u82e5\u6279\u4ef6\u4e2d\u6ca1\u6709\u7279\u6b8a\u8981\u6c42\uff0c\u4ec5\u5f00\u5c55BE\u7814\u7a76\u4e00\u822c\u4e0d\u5f71\u54cd\u4e34\u5e8a\u6279\u4ef6\u6709\u6548\u6027\u3002<\/p>\n\n\n\n

33<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u836f\u54c1\u4eff\u5236\u7814\u7a76\u8fc7\u7a0b\u4e2d\uff0c\u7533\u8bf7\u4eba\u4e70\u5230\u53c2\u6bd4\u5236\u5242\u65f6\u5176\u6709\u6548\u671f\u5df2\u7ecf\u8fc7\u4e86\u4e00\u5b9a\u65f6\u95f4\uff0c\u65e0\u6cd5\u505a\u5230\u4ee5\u751f\u4ea7\u65e5\u671f\u4e3a\u8d77\u59cb\u70b9\u8fdb\u884c\u53c2\u6bd4\u5236\u5242\u540e\u7eed\u7684\u7a33\u5b9a\u6027\u7814\u7a76\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u300a\u603b\u5c40\u5173\u4e8e\u53d1\u5e03\u5316\u5b66\u836f\u54c1\u65b0\u6ce8\u518c\u5206\u7c7b\u300b\u8981\u6c42\u603b\u7ed3\u6240\u8fdb\u884c\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u6837\u54c1\u60c5\u51b5\u3001\u8003\u5bdf\u6761\u4ef6\u3001\u8003\u5bdf\u6307\u6807\u548c\u8003\u5bdf\u7ed3\u679c\uff0c\u5bf9\u53d8\u5316\u8d8b\u52bf\u8fdb\u884c\u5206\u6790\uff0c\u63d0\u51fa\u8d2e\u5b58\u6761\u4ef6\u548c\u6709\u6548\u671f\uff0c\u5e76\u4e0e\u539f\u7814\u836f\u53ca\u836f\u5178\u6536\u8f7d\u7684\u540c\u54c1\u79cd\u7684\u8981\u6c42\u8fdb\u884c\u6bd4\u8f83\uff0c\u4eff\u5236\u836f\u7684\u7a33\u5b9a\u6027\u4e0d\u5f97\u66f4\u5dee\u3002<\/p>\n\n\n\n

34<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5728\u4e2d\u56fd\u5f00\u5c55\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u5426\u91c7\u7528\u5883\u5916\u4e0a\u5e02\u836f\u54c1\u4f5c\u5bf9\u7167\u836f\u7269\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u5883\u5916\u4e0a\u5e02\u836f\u54c1\uff0c\u5982\u4e2d\u56fd\u5883\u5185\u5df2\u6709\u6216\u66fe\u6709\u540c\u54c1\u79cd\u4e0a\u5e02\u7684\uff0c\u7533\u8bf7\u4eba\u53ef\u901a\u8fc7\u4e00\u6b21\u6027\u8fdb\u53e3\u7684\u65b9\u5f0f\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u4f5c\u4e3a\u5bf9\u7167\u836f\u7269\uff1b\u5176\u4ed6\u60c5\u5f62\uff0c\u4e00\u822c\u9700\u6309\u6ce8\u518c\u7a0b\u5e8f\u7533\u62a5\u540e\u65b9\u53ef\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

35<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u751f\u7269\u7c7b\u4f3c\u836f\u4e2d\u56fd\u7533\u8bf7\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\uff0c\u662f\u5426\u9700\u8981\u836f\u54c1\u8bc1\u4e66\uff08CPP\uff09\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u300a\u5173\u4e8e\u8c03\u6574\u8fdb\u53e3\u836f\u6ce8\u518c\u7ba1\u7406\u6709\u5173\u4e8b\u9879\u7684\u51b3\u5b9a  \u300b\u89c4\u5b9a\uff0c\u9664\u9884\u9632\u7528\u751f\u7269\u5236\u54c1\u5916\uff0c\u5728\u4e2d\u56fd\u8fdb\u884c\u56fd\u9645\u591a\u4e2d\u5fc3\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u7684\uff0c\u5141\u8bb8\u540c\u6b65\u5f00\u5c55I\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u53d6\u6d88\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269\u5e94\u5f53\u5df2\u5728\u5883\u5916\u6ce8\u518c\uff0c\u6216\u8005\u5df2\u7ecf\u8fdb\u5165II\u671f\u6216III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8981\u6c42\u3002<\/p>\n\n\n\n

36<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\u8f6c\u8ba9\u540e\u4e34\u5e8a\u767b\u8bb0\u95ee\u9898<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u9700\u7531\u539f\u4e34\u5e8a\u6279\u4ef6\u6301\u6709\u8005\u5728\u5e73\u53f0\u8fdb\u884c\u9884\u767b\u8bb0\uff0c\u9884\u767b\u8bb0\u6210\u529f\u540e\uff0c\u9700\u8fdb\u884c\u53d8\u66f4\u7533\u529e\u8005\u64cd\u4f5c\u3002\u8be6\u8bf7\u53c2\u89c1\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u5e73\u53f0\u201c\u5e2e\u52a9\u4e0e\u94fe\u63a5\u201d\u9875\u9762\u7684\u5e73\u53f0\u4f7f\u7528\u8bf4\u660e\u3002<\/p>\n\n\n\n

37<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u539f\u7814\u539f\u6599\u836f\u96be\u4ee5\u83b7\u5f97\uff0c\u5982\u4f55\u5f00\u5c55\u4eff\u5236\u539f\u6599\u836f\u4e0e\u539f\u7814\u539f\u6599\u836f\u7684\u5bf9\u6bd4\u7814\u7a76<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u539f\u5219\u4e0a\uff0c\u539f\u6599\u836f\u9700\u4e0e\u539f\u7814\u539f\u6599\u836f\u8fdb\u884c\u8d28\u91cf\u5bf9\u6bd4\u7814\u7a76\u3002\u5982\u539f\u7814\u539f\u6599\u836f\u5b9e\u5728\u65e0\u6cd5\u83b7\u5f97\uff0c\u53ef\u6309ICH\u6742\u8d28\u7814\u7a76\u6307\u5357\u8fdb\u884c\u5168\u9762\u7684\u6742\u8d28\u7814\u7a76\uff0c\u5173\u8054\u5236\u5242\u53ef\u4e0e\u539f\u7814\u5236\u5242\u8fdb\u884c\u8d28\u91cf\u5bf9\u6bd4\u3002<\/p>\n\n\n\n

38<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u65b0\u836f\u7814\u53d1\u8fc7\u7a0b\u4e2d\u5b58\u5728\u6742\u8d28\u9650\u5ea6\u53d8\u5316\u60c5\u51b5\uff0c\u5982\u4f55\u8fdb\u884c\u975e\u4e34\u5e8a\u836f\u7406\u6bd2\u7406\u6865\u63a5\u7814\u7a76\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4eba\u4f53\u8bd5\u9a8c\u4e2d\u7684\u6742\u8d28\u603b\u91cf\u5728\u52a8\u7269\u8bd5\u9a8c\u7ed3\u679c\u4e2d\u6709\u76f8\u5e94\u6570\u636e\u652f\u6301\u3002\u82e5\u9700\u5f00\u5c55\u52a8\u7269\u8bd5\u9a8c\uff0c\u53c2\u7167ICH  \u7684 Q3\uff0c\u901a\u5e38\u4e3a14-90\u5929\u7684\u91cd\u590d\u7ed9\u836f\u6bd2\u6027\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

39<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u4eff\u5236\u836f\u4f01\u4e1a\u8d2d\u4e70\u53c2\u6bd4\u5236\u5242\u540e\uff0c\u53c2\u6bd4\u5236\u5242\u7684\u751f\u4ea7\u5546\u548c\u6301\u8bc1\u5546\u5747\u53d1\u751f\u4e86\u53d8\u5316\uff0c\u662f\u5426\u9700\u91cd\u65b0\u8d2d\u4e70\u7814\u7a76\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4ece\u751f\u547d\u5468\u671f\u7ba1\u7406\u548c\u98ce\u9669\u63a7\u5236\u7684\u89d2\u5ea6\uff0c\u7533\u8bf7\u4eba\u5e94\u5bf9\u53c2\u6bd4\u5236\u5242\u7684\u751f\u4ea7\u5546\u548c\u6301\u8bc1\u5546\u53d8\u5316\u540e\u7684\u60c5\u51b5\u8fdb\u884c\u7814\u7a76\u548c\u8bc4\u4f30\uff0c\u6839\u636e\u8bc4\u4f30\u7ed3\u679c\u5224\u5b9a\u662f\u5426\u9700\u8981\u91cd\u65b0\u8d2d\u4e70\u53c2\u6bd4\u5236\u5242\u3002<\/p>\n\n\n\n

40<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6570\u5b57\u8ba4\u8bc1\u8bc1\u4e66\u5982\u4f55\u5f00\u901a\uff1f\u5f00\u901a\u540e\u5982\u4f55\u4f7f\u7528\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u8bf7\u53c2\u7167\u836f\u5ba1\u4e2d\u5fc3\u7f51\u7ad9\u53d1\u5e03\u7684\u76f8\u5173\u901a\u77e5\u529e\u7406\uff0c\u76f8\u5173\u901a\u77e5\u94fe\u63a5\u5982\u4e0b\uff1a <\/p>\n\n\n\n

\uff08\u4e00\uff09 \u65b0\u7248CDE\u7f51\u7ad9\u300a\u7533\u8bf7\u4eba\u4e4b\u7a97\u300b\u9891\u9053\u5c06\u91c7\u7528\u5b9e\u540d\u8eab\u4efd\u9a8c\u8bc1\u548cCA\u5355\u4f4d\u6570\u5b57\u8bc1\u4e66\u8ba4\u8bc1\u5b89\u5168\u673a\u5236<\/p>\n\n\n\n

\uff08http:\/\/www.cde.org.cn\/news.do?method=largeInfo&id=312712\uff09 <\/p>\n\n\n\n

\uff08\u4e8c\uff09\u5173\u4e8e\u65b0\u7248CDE\u7f51\u7ad9\u300a\u7533\u8bf7\u4eba\u4e4b\u7a97\u300b\u9891\u9053\u529e\u7406\u5b9e\u540d\u8eab\u4efd\u9a8c\u8bc1\u7684\u901a\u77e5<\/p>\n\n\n\n

\uff08http:\/\/www.cde.org.cn\/news.do?method=largeInfo&id=312720\uff09  <\/p>\n\n\n\n

\uff08\u4e09\uff09\u5173\u4e8e\u201c\u5b9e\u540d\u8eab\u4efd\u9a8c\u8bc1\u201d\u57fa\u7840\u4e0a\u529e\u7406CA\u5355\u4f4d\u6570\u5b57\u8bc1\u4e66\u7684\u901a\u77e5<\/p>\n\n\n\n

\uff08http:\/\/www.cde.org.cn\/news.do?method=largeInfo&id=312721\uff09<\/p>\n\n\n\n

41<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5728\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8bbe\u8ba1\u65f6\uff0c\u5728\u540c\u4e00\u4e2a\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u65b9\u6848\u4e2d\uff0c\u7a7a\u8179\u4e0e\u9910\u540e\u4f7f\u7528\u7684\u53c2\u6bd4\u5236\u5242\u6216\u53d7\u8bd5\u5236\u5242\uff0c\u80fd\u5426\u4e0d\u662f\u540c\u4e00\u6279\u53f7\u7684\u6837\u54c1\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5728\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8bbe\u8ba1\u65f6\uff0c\u540c\u4e00\u4e2a\u8bd5\u9a8c\u4e2d\u5982\u9910\u540e\u6216\u8005\u7a7a\u8179\u5e94\u91c7\u7528\u540c\u4e00\u6279\u6b21\u836f\u54c1\u8fdb\u884c\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

42<\/strong><\/p>\n\n\n\n

\u95ee\uff1aCAR-T\u7c7b\u4ea7\u54c1\u5df2\u6709\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u662f\u5426\u53ef\u4ee5\u514d\u9664\u975e\u4e34\u5e8a\u8bd5\u9a8c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u975e\u4e34\u5e8a\u7814\u7a76\u8bc4\u4ef7\u7684\u76ee\u7684\u662f\u4e3a\u4e86\u8bc4\u4f30\u5e76\u7ba1\u63a7\u62df\u5b9a\u4e34\u5e8a\u65b9\u6848\u7684\u98ce\u9669\u4ee5\u4fdd\u969c\u53d7\u8bd5\u8005\u5b89\u5168\uff0c\u5982\u679c\u5df2\u6709\u4e34\u5e8a\u6570\u636e\u7ecf\u8fc7\u8bc4\u4f30\u540e\u53ef\u4fdd\u8bc1\u4e34\u5e8a\u53d7\u8bd5\u8005\u5b89\u5168\u6027\uff0cCAR-T\u4ea7\u54c1IND\u671f\u95f4\u7684\u975e\u4e34\u5e8a\u7814\u7a76\u53ef\u4ee5\u672c\u7740\u5177\u4f53\u54c1\u79cd\u5177\u4f53\u5206\u6790\u7684\u539f\u5219\u514d\u9664\u4e0d\u5fc5\u8981\u7684\u52a8\u7269\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

43<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5316\u5b66\u836f\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5907\u6848\u8d44\u6599\u4e2d\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u8981\u6c42<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u7167BE\u5907\u6848\u7684\u76f8\u5173\u89c4\u5b9a\uff1a\u5e94\u63d0\u4f9b\u4e09\u6279\u4e2d\u8bd5\u4ee5\u4e0a\u89c4\u6a21\u81ea\u5236\u6837\u54c1\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u6570\u636e\uff0c\u8bd5\u9a8c\u6837\u54c1\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\u4e2d\u8bd5\u653e\u5927\u6279\u4ee5\u53ca\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6279\u6837\u54c1\u3002\u5e94\u63d0\u4f9b\u81f3\u5c11\u4e09\u4e2a\u6708\u52a0\u901f\u4e0e\u957f\u671f\u7559\u6837\u7814\u7a76\u6570\u636e\u3002\u5728\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u671f\u95f4\u7ee7\u7eed\u8fdb\u884c\u4ee5\u4e0a\u6837\u54c1\u8fdb\u884c\u52a0\u901f\u4e0e\u957f\u671f\u7559\u6837\u7a33\u5b9a\u6027\u7814\u7a76\u3002<\/p>\n\n\n\n

44<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5728\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8bbe\u8ba1\u65f6\uff0c\u5bf9\u4e8e\u9ad8\u53d8\u5f02\u836f\u7269\uff0c\u53ef\u6839\u636e\u53c2\u6bd4\u5236\u5242\u7684\u4e2a\u4f53\u5185\u53d8\u5f02\uff0c\u5c06\u7b49\u6548\u6027\u8bc4\u4ef7\u6807\u51c6\u4f5c\u9002\u5f53\u6bd4\u4f8b\u7684\u8c03\u6574\uff0c\u8be5\u5982\u4f55\u64cd\u4f5c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u53ef\u4ee5\u53c2\u7167\u7f8e\u56fdFDA\u76f8\u5173\u6307\u5357\u4e2d\u63a8\u8350\u7684\u53c2\u6bd4\u5236\u5242\u6821\u6b63\u7684\u5e73\u5747\u751f\u7269\u7b49\u6548\u6027(reference-scaled average bioequivalence\uff0cRSABE)\u7edf\u8ba1\u65b9\u6cd5\u8bbe\u8ba1\u8bd5\u9a8c\uff0c\u4f46\u662f\u5728\u91c7\u7528RSABE\u6cd5\u524d\u9700\u7ed3\u5408\u65e2\u5f80\u7814\u7a76\u6216\u6587\u732e\u62a5\u9053\uff0c\u5206\u6790\u9020\u6210\u836f\u7269\u5236\u5242\u9ad8\u53d8\u5f02\u7279\u5f81\u7684\u539f\u56e0\uff0c\u8bba\u8bc1\u548c\u8bc4\u4f30\u91c7\u7528RSABE\u6cd5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u9002\u7528\u6027\u3002\u5e76\u5728\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u53ca\u7edf\u8ba1\u5b66\u8ba1\u5212\u4e66\u4e2d\u660e\u786e\u8bf4\u660e\u6240\u4f7f\u7528\u7684\u7edf\u8ba1\u65b9\u6cd5\u3002<\/p>\n\n\n\n

45<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u5c1a\u672a\u516c\u5e03\u53c2\u6bd4\u5236\u5242\u7684\u54c1\u79cd\uff0c\u4f01\u4e1a\u7533\u8bf7\u5907\u6848\u540e\u56fd\u5bb6\u516c\u5e03\u53c2\u6bd4\u5236\u5242\u7684\u6709\u5173\u4e8b\u5b9c<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u5c1a\u672a\u516c\u5e03\u53c2\u6bd4\u5236\u5242\u7684\u54c1\u79cd\uff0c\u836f\u5ba1\u4e2d\u5fc3\u5c06\u6839\u636e100\u53f7\u516c\u544a\u7684\u53c2\u6bd4\u5236\u5242\u9074\u9009\u539f\u5219\uff0c\u6839\u636e\u4f01\u4e1a\u5907\u6848\u60c5\u51b5\uff0c\u5b9a\u671f\u7ec4\u7ec7\u4e13\u5bb6\u8ba8\u8bba\uff0c\u540c\u65f6\u7ed3\u5408\u540c\u54c1\u79cd\u65b0\u4eff\u5236\u836f\u7684\u5ba1\u8bc4\uff0c\u5b9a\u671f\u516c\u5e03\u53c2\u6bd4\u5236\u5242\u3002<\/p>\n\n\n\n

46<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5bf9\u4e8eCFDA\u516c\u5e03\u7684289\u57fa\u836f\u76ee\u5f55\u4e2d\u53ef\u8c41\u514d\u6216\u8005\u7b80\u5316\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c(BE\uff09\u54c1\u79cd\u540d\u5355\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u4e2d\u63d0\u51fa\u53ef\u4ee5\u201c\u91c7\u7528\u836f\u5b66\u4e00\u81f4\u6027\u8bc4\u4ef7\u65b9\u6cd5\uff0cBE\u8c41\u514d\u201d\u60c5\u5f62\uff1a1\u3001\u5df2\u7ecf\u660e\u786e\u7528\u836f\u5b66\u4e00\u81f4\u6027\u8bc4\u4ef7\u7684\u65b9\u6cd5\uff0c\u90a3\u662f\u5426\u8fd8\u9700\u8981\u6309\u7167\u300a\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u8c41\u514d\u6307\u5bfc\u539f\u5219\u300b\u7684\u8981\u6c42\u63d0\u4ea4\u9ad8\u6eb6\u89e3\u6027\u6570\u636e\u548c\u9ad8\u6e17\u900f\u6027\u6570\u636e\uff1f2\u3001\u5982\u679c\u9700\u8981\u63d0\u4ea4\u9ad8\u6e17\u900f\u6027\u7814\u7a76\u8d44\u6599\uff0c\u90a3\u4e48\uff0c\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u662f\u5426\u5fc5\u987b\u63d0\u4ea4  \uff1f\u4f7f\u7528\u539f\u7814\u8bf4\u660e\u4e66\u4e2d\u7684\u836f\u4ee3\u7814\u7a76\u6570\u636e\u662f\u5426\u53ef\u4ee5\uff1f3\u3001\u662f\u5426\u5fc5\u987b\u63d0\u4f9b\u8f85\u6599\u5bf9\u5438\u6536\u7684\u5f71\u54cd\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>1.  \u5bf9\u4e8e\u6309\u7167BCS 1\u7c7b\u7533\u8bf7\u8c41\u514d\u7684\u54c1\u79cd\uff0c\u9700\u8981\u6309\u7167\u300a\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u8c41\u514d\u6307\u5bfc\u539f\u5219\u300b\uff0c\u63d0\u4ea4\u6eb6\u89e3\u6027\u548c\u6e17\u900f\u6027\u8d44\u6599\uff1b<\/p>\n\n\n\n

2.  \u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u662f\u8bc1\u660e\u9ad8\u6e17\u900f\u6027\u6700\u76f4\u89c2\u6709\u6548\u7684\u65b9\u6cd5\uff0c\u539f\u7814\u8bf4\u660e\u4e66\u7684\u4eba\u4f53\u836f\u4ee3\u6570\u636e\u53ef\u4f5c\u4e3a\u836f\u7269\u6e17\u900f\u6027\u7684\u4f9d\u636e\u4e4b\u4e00\uff0c\u5f53\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u6570\u636e\u4e0d\u5145\u5206\u65f6 \uff0c\u4f53\u5916\u6e17\u900f\u6027\u8bd5\u9a8c\u5982Caco-2\u8bd5\u9a8c\u6570\u636e\u4e5f\u53ef\u4f5c\u4e3a\u652f\u6301\u6027\u8bc1\u636e\u3002\u5fc5\u8981\u65f6\uff0c\u8fd8\u5e94\u63d0\u4f9b\u989d\u5916\u7684\u6587\u732e\u8d44\u6599\u8fdb\u884c\u4f50\u8bc1\u3002<\/p>\n\n\n\n

3.  \u6309\u7167BCS1\u7c7b\u7533\u8bf7\u8c41\u514d\u7684\u54c1\u79cd\uff0c\u5f53\u8f85\u6599\u79cd\u7c7b\u548c\u7528\u91cf\u4e0e\u53c2\u6bd4\u5236\u5242\u4e0d\u4e00\u81f4\u65f6\uff0c\u9700\u63d0\u4f9b\u6570\u636e\u8bc1\u660e\u8f85\u6599\u5bf9\u5438\u6536\u4ea7\u751f\u7684\u5f71\u54cd\u3002<\/p>\n\n\n\n

47<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u56fd\u5916\u4e0a\u5e02\u56fd\u5185\u672a\u4e0a\u5e02\u836f\u54c1\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8981\u6c42\u4e0e\u7a0b\u5e8f\u662f\u4ec0\u4e48\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e2016\u5e74\u300a\u5173\u4e8e\u7814\u5236\u8fc7\u7a0b\u4e2d\u6240\u9700\u7814\u7a76\u7528\u5bf9\u7167\u836f\u54c1\u4e00\u6b21\u6027\u8fdb\u53e3\u6709\u5173\u4e8b\u5b9c\u7684\u516c\u544a\u300b\u89c4\u5b9a\uff0c\u5bf9\u4e8e\u5883\u5916\u4e0a\u5e02\u4f46\u5883\u5185\u672a\u4e0a\u5e02\u7684\u836f\u54c1\uff0c\u5982\u62df\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u4ee5\u7533\u8bf7\u4e00\u6b21\u6027\u8fdb\u53e3\uff0c\u8fdb\u53e3\u540e\u68c0\u9a8c\u5408\u683c\u65b9\u53ef\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u3002\u751f\u7269\u5236\u54c1\u4e34\u5e8a\u6bd4\u5bf9\u7814\u7a76\u7528\u7684\u53c2\u7167\u836f\uff0c\u5e94\u5728\u6211\u56fd\u6279\u51c6\u6ce8\u518c\uff0c\u6309\u751f\u7269\u7c7b\u4f3c\u836f\u6279\u51c6\u7684\u4ea7\u54c1\u539f\u5219\u4e0a\u4e0d\u53ef\u7528\u4f5c\u53c2\u7167\u836f\u3002\u3002<\/p>\n\n\n\n

48<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u8fdb\u53e3\u836f\u54c1\u518d\u6ce8\u518c\uff0c\u53ef\u4ee5\u540c\u65f6\u5408\u5e76\u7533\u8bf7\u53d8\u66f4\u6301\u8bc1\u5546\u548c\u751f\u4ea7\u5382\u5730\u5740\u5417\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u5173\u4e8e\u8fdb\u53e3\u836f\u54c1\u518d\u6ce8\u518c\u6709\u5173\u4e8b\u9879\u7684\u516c\u544a\u300b\uff08\u56fd\u98df\u836f\u76d1\u6ce8[2009]18\u53f7\uff09\u8981\u6c42\uff0c\u201c\u8fdb\u53e3\u836f\u54c1\u518d\u6ce8\u518c\u4e0d\u5e94\u540c\u65f6\u7533\u62a5\u6539\u6362\u4ea7\u5730\u3001\u589e\u52a0\u836f\u54c1\u89c4\u683c\u7684\u8865\u5145\u7533\u8bf7\uff0c\u6539\u6362\u4ea7\u5730\u3001\u589e\u52a0\u836f\u54c1\u89c4\u683c\u5fc5\u987b\u6309\u7167\u8865\u5145\u7533\u8bf7\u7684\u7a0b\u5e8f\u5355\u72ec\u7533\u62a5\u3002\u201d<\/p>\n\n\n\n

49<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5236\u5242\u6240\u7528\u539f\u6599\u836f\u8d28\u91cf\u6807\u51c6\u53d8\u66f4\u600e\u4e48\u7533\u62a5\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u539f\u6599\u836f\u5e94\u6309\u71672017\u5e74146\u53f7\u516c\u544a\u8981\u6c42\u8fdb\u884c\u767b\u8bb0\uff0c\u5236\u5242\u5e94\u5145\u5206\u8bc4\u4f30\u539f\u6599\u836f\u53d8\u66f4\u5bf9\u5236\u5242\u7684\u5f71\u54cd\uff0c\u6309\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u8981\u6c42\u7533\u62a5\u8865\u5145\u7533\u8bf7\u3002<\/p>\n\n\n\n

50<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6cd5\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u5b89\u5168\u5c40\uff08ANSM\uff09\u7f51\u7ad9\u7535\u5b50\u7248\u7684GMP\u8bc1\u4e66\u80fd\u5426\u8ba4\u53ef\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u73b0\u9636\u6bb5\uff0c\u8ba4\u53ef\u6cd5\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u5b89\u5168\u5c40\uff08ANSM\uff09\u51fa\u5177\u7684\u7535\u5b50\u7248GMP\u8bc1\u4e66\u3002<\/p>\n\n\n\n

51<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u8fdb\u53e3\u836f\u54c1\u7533\u62a5\u65f6\uff0c\u4ee5\u7f8e\u56fdFDA\u51fa\u5177\u7684\u836f\u54c1GMP\u6838\u67e5\u4fe1\u4f5c\u4e3a\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u7b26\u5408\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u8bc1\u660e\u6587\u4ef6\u7684\u5177\u4f53\u8981\u6c42\u662f\u4ec0\u4e48\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u8fdb\u53e3\u836f\u54c1\u53d7\u7406\u65f6\uff0c\u8ba4\u53ef\u5883\u5916\u76d1\u7ba1\u673a\u6784GMP\u6838\u67e5\u4fe1\u9012\u4ea4\u5f62\u5f0f\uff0c\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u76f8\u5173\u4fe1\u606f\u5e94\u4e0e\u6240\u7533\u62a5\u4fe1\u606f\u4e00\u81f4\uff0c\u987b\u7ecf\u6240\u5728\u56fd\u516c\u8bc1\u673a\u5173\u516c\u8bc1\u53ca\u9a7b\u6240\u5728\u56fd\u4e2d\u56fd\u4f7f\u9886\u9986\u8ba4\u8bc1\u3002<\/p>\n\n\n\n

52<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e8e\u751f\u7269\u5236\u54c1\u7684\u53d8\u66f4\uff0c\u7533\u8bf7\u4eba\u5e94\u4ece\u6280\u672f\u5c42\u9762\u7ed9\u4e88\u5145\u5206\u7684\u8bc4\u4f30\u548c\u9a8c\u8bc1\uff0c\u53ef\u6bd4\u6027\u7814\u7a76\u662f\u751f\u7269\u5236\u54c1\u53d8\u66f4\u8bc4\u4ef7\u7684\u57fa\u7840\u548c\u6210\u529f\u7684\u5173\u952e\u3002\u76ee\u7684\u5728\u4e8e\u901a\u8fc7\u6536\u96c6\u76f8\u5173\u6280\u672f\u8d44\u6599\u5bf9\u6bd4\u5206\u6790\u786e\u8ba4\u53d8\u66f4\u6709\u6ca1\u6709\u5bf9\u751f\u7269\u5236\u54c1\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd\u3002  \u5982\u679c\u53d8\u66f4\u524d\u540e\u7684\u4ea7\u54c1\u7684\u751f\u4ea7\u5de5\u827a\u3001\u8d28\u91cf\u7279\u6027\u5206\u6790\u548c\u7a33\u5b9a\u6027\u7814\u7a76\u8db3\u4ee5\u8bc1\u660e\u53ef\u6bd4\u6027\uff0c\u5219\u65e0\u9700\u5bf9\u53d8\u66f4\u540e\u4ea7\u54c1\u5b9e\u65bd\u975e\u4e34\u5e8a\u6216\u4e34\u5e8a\u7814\u7a76\u3002  \u5f53\u8d28\u91cf\u5206\u6790\u5bf9\u6bd4\u7ed3\u679c\u4e0d\u88ab\u63a5\u53d7\u6216\u53d8\u66f4\u524d\u540e\u4ea7\u54c1\u51fa\u73b0\u8f83\u5927\u5dee\u5f02\u6216\u53ef\u6bd4\u6027\u7814\u7a76\u9879\u76ee\u5b58\u5728\u6b20\u7f3a\uff0c\u65e0\u6cd5\u901a\u8fc7\u975e\u4e34\u5e8a\u7814\u7a76\u8bc1\u5b9e\u53d8\u66f4\u5bf9\u4ea7\u54c1\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u4ea7\u751f\u7684\u5f71\u54cd\u65f6\uff0c\u9700\u8981\u8fdb\u884c\u6865\u63a5\u6027\u6216\u786e\u8bc1\u6027\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u8bc1\u660e\u53ef\u6bd4\u6027\u5e76\u4e0d\u610f\u5473\u7740\u4ea7\u54c1\u7684\u8d28\u91cf\u5c5e\u6027\u5728\u573a\u5730\u53d8\u66f4\u524d\u540e\u662f\u5b8c\u5168\u7b49\u540c\u7684\uff0c\u4f46\u5e94\u8be5\u662f\u9ad8\u5ea6\u76f8\u4f3c\u7684\uff0c\u5e76\u4e14\u4f9d\u636e\u73b0\u6709\u7684\u77e5\u8bc6\u548c\u7814\u7a76\u7ed3\u679c\u8db3\u4ee5\u9884\u671f\u5176\u5728\u4ea7\u54c1\u8d28\u91cf\u5c5e\u6027\u65b9\u9762\u7684\u5dee\u5f02\u4e0d\u4f1a\u5bf9\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4ea7\u751f\u4efb\u4f55\u4e0d\u826f\u5f71\u54cd\u3002<\/p>\n\n\n\n

53<\/strong><\/p>\n\n\n\n

\u95ee\uff1aBE\u8bd5\u9a8c\u7528\u6837\u54c1\u751f\u4ea7\u65f6\uff0c\u4f01\u4e1a\u662f\u5426\u5fc5\u987b\u5df2\u53d6\u5f97\u8be5\u751f\u4ea7\u7ebf\u7684GMP\u8bc1\u4e66\uff1f\u836f\u54c1\u751f\u4ea7\u8bb8\u53ef\u8bc1\u662f\u5426\u5fc5\u987b\u5df2\u5305\u542b\u76f8\u5e94\u54c1\u79cd\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u5f53\u524d\u6cd5\u89c4\u548c\u6280\u672f\u6307\u5357\u8981\u6c42\uff0cBE\u8bd5\u9a8c\u7528\u6837\u54c1\u5e94\u5728\u8be5\u5236\u5242\u7684\u5b9e\u9645\u751f\u4ea7\u7ebf\u6216\u7b26\u5408GMP\u8981\u6c42\u7684\u4e2d\u8bd5\u53ca\u4ee5\u4e0a\u89c4\u6a21\u8f66\u95f4\u751f\u4ea7\uff0c\u8bd5\u9a8c\u5236\u5242\u7684\u5236\u5907\u89c4\u6a21\u5e94\u8fbe\u5230\u4e2d\u8bd5\u4ee5\u4e0a\uff0c\u91c7\u7528\u7684\u5904\u65b9\u5de5\u827a\u5e94\u4e0e\u5927\u751f\u4ea7\u4e00\u81f4\uff0c\u5236\u5907\u8fc7\u7a0b\u5e94\u4e25\u683c\u6267\u884cGMP\u8981\u6c42\u3002<\/p>\n\n\n\n

54<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6813\u5242\u54c1\u79cd\u662f\u5426\u6bcf\u4e2a\u5305\u88c5\u76d2\u5185\u7684\u5355\u72ec\u5242\u91cf\u7684\u6813\u5242\u90fd\u8981\u6c42\u6253\u4e0a\u6279\u53f7?<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u76ee\u524d\u6cd5\u89c4\u5bf9\u6b64\u6ca1\u6709\u660e\u786e\u89c4\u5b9a\uff0c\u4f46\u4ece\u7ba1\u7406\u4f7f\u7528\u548c\u98ce\u9669\u63a7\u5236\u7b49\u89d2\u5ea6\uff0c\u5efa\u8bae\u5c06\u6279\u53f7\u6807\u8bc6\u5728\u5404\u7ea7\u5305\u88c5\u5355\u5143\u4e0a\uff0c\u5305\u62ec\u6700\u5c0f\u5305\u88c5\u5355\u5143\u3002<\/p>\n\n\n\n

55<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u5c40\u4ee4\u7b2c28\u53f7\uff09\u4ee5\u53ca\u300a\u603b\u5c40\u5173\u4e8e\u53d1\u5e03\u5316\u5b66\u836f\u54c1\u65b0\u6ce8\u518c\u5206\u7c7b\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff08\u8bd5\u884c\uff09\u7684\u901a\u544a\u300b\uff082016\u5e74  \u7b2c80\u53f7\uff09\u8981\u6c42\uff0c\u201c\u672a\u5728\u751f\u4ea7\u56fd\u5bb6\u6216\u8005\u5730\u533a\u83b7\u51c6\u4e0a\u5e02\u9500\u552e\u7684\uff0c\u53ef\u4ee5\u63d0\u4f9b\u6301\u8bc1\u5546\u603b\u90e8\u6240\u5728\u56fd\u6216\u8005\u5730\u533a\u836f\u54c1\u7ba1\u7406\u673a\u6784\u51fa\u5177\u7684\u5141\u8bb8\u836f\u54c1\u4e0a\u5e02\u9500\u552e\u53ca\u8be5\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u7b26\u5408\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u7684\u8bc1\u660e\u6587\u4ef6\u3002\u201d<\/p>\n\n\n\n

56<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u653e\u5c04\u6027\u836f\u54c1\u7acb\u9879\u7684\u6cd5\u89c4\u8981\u6c42<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4f9d\u636e\u300a\u56fd\u52a1\u9662\u5173\u4e8e\u7b2c\u56db\u6279\u53d6\u6d88\u548c\u8c03\u6574\u884c\u653f\u5ba1\u6279\u9879\u76ee\u7684\u51b3\u5b9a\u300b\u56fd\u53d1[2007]33\u53f7\u9644\u4ef61  \u7b2c92\u9879\uff0c\u5df2\u53d6\u6d88\u653e\u5c04\u6027\u836f\u54c1\u7814\u5236\u7acb\u9879\u3002<\/p>\n\n\n\n

57<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u975e\u4e34\u5e8a\u8bd5\u9a8c\u59d4\u6258\u7814\u7a76\u7684\u8981\u6c42<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u5c40\u4ee4\u7b2c28\u53f7\uff09\u7b2c\u4e8c\u5341\u56db\u6761\u89c4\u5b9a\uff0c\u7533\u8bf7\u4eba\u59d4\u6258\u5176\u4ed6\u673a\u6784\u8fdb\u884c\u836f\u7269\u7814\u7a76\u6216\u8005\u8fdb\u884c\u5355\u9879\u8bd5\u9a8c\u3001\u68c0\u6d4b\u3001\u6837\u54c1\u7684\u8bd5\u5236\u7b49\u7684\uff0c\u5e94\u5f53\u4e0e\u88ab\u59d4\u6258\u65b9\u7b7e\u8ba2\u5408\u540c\uff0c\u5e76\u5728\u7533\u8bf7\u6ce8\u518c\u65f6\u4e88\u4ee5\u8bf4\u660e\u3002\u56e0\u6b64\u7533\u8bf7\u8868\u4e2d\u5e94\u5f53\u586b\u5199\u5168\u90e8\u7684\u59d4\u6258\u7814\u7a76\u673a\u6784\u3002\u5177\u4f53\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff0c\u6309\u7167\u300a\u603b\u5c40\u5173\u4e8e\u53d1\u5e03\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5ba1\u67e5\u6307\u5357\uff08\u8bd5\u884c\uff09\u7684\u901a\u544a\u300b\uff082017\u5e74\u7b2c194\u53f7\uff09\u9644\u4ef6\u4e2d\u76f8\u5e94\u5185\u5bb9\u6267\u884c\u3002<\/p>\n\n\n\n

58<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u8fdb\u53e3\u4ea7\u54c1\u591a\u4e2a\u5305\u88c5\u5382\u7684\u7533\u62a5<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u7533\u8bf7\u4eba\u53ef\u5728\u7533\u8bf7\u8868\u4e2d\u673a\u67843\uff08\u8fdb\u53e3\u836f\u54c1\u56fd\u5916\u5305\u88c5\u5382\uff09\u4e00\u680f\u53ef\u586b\u5199\u591a\u4e2a\u5305\u88c5\u5382\u540d\u79f0\u548c\u5730\u5740\uff0c\u5404\u5305\u88c5\u5382\u4e2d\u95f4\u7528\u5206\u53f7\u95f4\u9694\u4ee5\u793a\u533a\u522b\u3002<\/p>\n\n\n\n

59<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u51e1\u5728\u6211\u56fd\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff08\u542b\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u8bd5\u9a8c\u3001I\u3001\u2161\u3001\u2162\u3001\u2163\u671f\u8bd5\u9a8c\u7b49\uff09\u7684\uff0c\u5747\u5e94\u767b\u9646\u4fe1\u606f\u5e73\u53f0\uff0c\u6309\u8981\u6c42\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u4e0e\u4fe1\u606f\u516c\u793a\u3002\u5df2\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7533\u8bf7\uff0c\u63d0\u51fa\u540e\u7eed\u6ce8\u518c\u7533\u8bf7\u65f6\u5e94\u540c\u65f6\u63d0\u4ea4\u6309\u7167\u300a\u5173\u4e8e\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4fe1\u606f\u5e73\u53f0\u7684\u516c\u544a\u300b\uff08\u7b2c28\u53f7\uff09\u8981\u6c42\u5df2\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u4e0e\u4fe1\u606f\u516c\u793a\u7684\u76f8\u5173\u6750\u6599\u3002\u7b26\u5408257\u53f7\u516c\u544a\u7684\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\uff0c\u5e94\u6309\u7167\u8981\u6c42\u5728\u76f8\u5e94\u5e73\u53f0\u8fdb\u884c\u5907\u6848\u3002<\/p>\n\n\n\n

60<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff082015\u5e74\u7b2c  122\u53f7\uff09\u8981\u6c42\uff0c\u5728\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\uff0c\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u7684\u7533\u8bf7\u4eba\u673a\u6784\u66f4\u540d\uff08\u4e3b\u4f53\u4e0d\u53d8\uff09\u3001\u8054\u7cfb\u65b9\u5f0f\u53d8\u66f4\uff08\u4ec5\u9650\u4e8e\u7533\u8bf7\u4eba\u8054\u7cfb\u7535\u8bdd\u3001\u4f20\u771f\u3001\u7535\u5b50\u90ae\u7bb1\u5730\u5740\u7684\u53d8\u66f4\uff09\u3001\u6ce8\u518c\u5730\u5740\u53d8\u66f4\uff08\u4e0d\u6539\u53d8\u751f\u4ea7\u5730\u5740\uff09\u3001\u62df\u4f7f\u7528\u5546\u54c1\u540d\u79f0\u589e\u52a0\u6216\u6539\u53d8\u7684\uff0c\u7531\u539f\u53d7\u7406\u90e8\u95e8\u5ba1\u6838\u540e\u901a\u77e5\u836f\u54c1\u6280\u672f\u5ba1\u8bc4\u673a\u6784\u3002<\/p>\n\n\n\n

61<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u7533\u8bf7\u6838\u9500\u5546\u54c1\u540d\u79f0\u7684\u7533\u62a5\u65b9\u5f0f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff082015\u5e74\u7b2c  122\u53f7\uff09\u8981\u6c42\uff0c\u5e94\u6309\u8865\u5145\u7533\u8bf7\u7533\u62a5\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef6\u836f\u54c1\u8865\u5145\u6ce8\u518c\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c36\u9879\u529e\u7406\uff0c\u5e76\u5e94\u7b26\u5408\u300a\u5173\u4e8e\u529e\u7406\u64a4\u9500\u5546\u54c1\u540d\u8865\u5145\u7533\u8bf7\u6709\u5173\u4e8b\u9879\u7684\u901a\u77e5\u300b\uff08\u98df\u836f\u76d1\u529e\u6ce8[2012]130\u53f7\uff09\u76f8\u5173\u8981\u6c42\u3002<\/p>\n\n\n\n

62<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff082015\u5e74\u7b2c  122\u53f7\uff09\u8981\u6c42\uff0c\u773c\u7528\u5236\u5242\u7533\u8bf7\u53d8\u66f4\u6700\u5c0f\u5236\u5242\u5355\u4f4d\u88c5\u91cf\uff0c\u5e94\u6309\u8865\u5145\u7533\u8bf7\u7533\u62a5\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c5\u9879\u7684\u7a0b\u5e8f\u548c\u8981\u6c42\u529e\u7406\u3002<\/p>\n\n\n\n

63<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff082015\u5e74\u7b2c  122\u53f7\uff09\u8981\u6c42\uff0c\u6b64\u7c7b\u60c5\u5f62\u5e94\u6309\u8865\u5145\u7533\u8bf7\u7533\u62a5\uff0c\u6309\u7167\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6ce8\u518c\u4e8b\u9879\u7b2c18\u9879\u529e\u7406\u3002<\/p>\n\n\n\n

64<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u6ce8\u518c\u6709\u5173\u4e8b\u5b9c\u7684\u516c\u544a\u300b\uff082009\u5e74\u7b2c  \u7b2c16\u53f7\uff09\u89c4\u5b9a\uff0c\u542b\u6297\u83cc\u3001\u6d88\u708e\u836f\u54c1\u7684\u521b\u53e3\u8d34\u3001\u4e2d\u836f\u5916\u7528\u8d34\u6577\u7c7b\u4ea7\u54c1\u7b49\uff0c\u5c5e\u4e8e\u4ee5\u836f\u54c1\u4e3a\u4e3b\u7684\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\uff0c\u6309\u836f\u54c1\u8fdb\u884c\u6ce8\u518c\u7ba1\u7406\u3002<\/p>\n\n\n\n

65<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u6ce8\u518c\u6709\u5173\u4e8b\u5b9c\u7684\u516c\u544a\u300b\uff082009\u5e74\u7b2c  \u7b2c16\u53f7\uff09\u89c4\u5b9a\uff0c\u5e26\u836f\u7269\u6d82\u5c42\u7684\u652f\u67b6\uff0c\u5e26\u6297\u83cc\u6d82\u5c42\u7684\u5bfc\u7ba1\u3001\u542b\u836f\u907f\u5b55\u5957\u3001\u542b\u836f\u8282\u80b2\u73af\u7b49\uff0c\u5c5e\u4e8e\u4ee5\u533b\u7597\u5668\u68b0\u4e3a\u4e3b\u7684\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\uff0c\u6309\u533b\u7597\u5668\u68b0\u8fdb\u884c\u6ce8\u518c\u7ba1\u7406\u3002<\/p>\n\n\n\n

66<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u672a\u5728\u56fd\u5185\u4e0a\u5e02\u7684\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u7684\u7533\u62a5\u95ee\u9898<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u5173\u4e8e\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u6ce8\u518c\u6709\u5173\u4e8b\u5b9c\u7684\u516c\u544a\u300b\uff082009\u5e74\u7b2c  \u7b2c16\u53f7\uff09\u89c4\u5b9a\uff0c\u62df\u7533\u62a5\u6ce8\u518c\u7684\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\uff0c\u5982\u8be5\u7c7b\u4ea7\u54c1\u5c1a\u672a\u5728\u4e2d\u56fd\u83b7\u51c6\u4e0a\u5e02\uff0c\u7533\u8bf7\u4eba\u5e94\u5f53\u5728\u7533\u62a5\u6ce8\u518c\u524d\uff0c\u5411\u884c\u653f\u53d7\u7406\u670d\u52a1\u4e2d\u5fc3\u7533\u8bf7\u4ea7\u54c1\u5c5e\u6027\u754c\u5b9a\uff0c\u6839\u636e\u4ea7\u54c1\u5c5e\u6027\u5ba1\u5b9a\u610f\u89c1\uff0c\u7533\u62a5\u836f\u54c1\/\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7533\u8bf7\uff0c\u5e76\u5728\u7533\u8bf7\u8868\u4e2d\u6ce8\u660e\u201c\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u201d\u3002\u4e3a\u5f15\u5bfc\u7533\u8bf7\u4eba\u5408\u7406\u7533\u62a5\uff0c\u603b\u5c40\u5b9a\u671f\u516c\u5e03\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u7684\u754c\u5b9a\u7ed3\u679c\uff0c\u7533\u8bf7\u4eba\u53ef\u8fdb\u884c\u53c2\u8003\u3002<\/p>\n\n\n\n

67<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u81ea\u67e5\u6838\u67e5\u8303\u56f4\u95ee\u9898<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6309\u7167\u300a\u603b\u5c40\u5173\u4e8e\u8c03\u6574\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u516c\u544a\u300b\uff082017\u5e74\u7b2c  134\u53f7\uff09\u89c4\u5b9a\uff1a\u201c\u96c6\u4e2d\u53d7\u7406\u540e\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u65b0\u53d7\u7406\u7684\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\uff0c\u6839\u636e\u836f\u54c1\u6280\u672f\u5ba1\u8bc4\u4e2d\u7684\u9700\u6c42\uff0c\u7531\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u98df\u54c1\u836f\u54c1\u5ba1\u6838\u67e5\u9a8c\u4e2d\u5fc3\u7edf\u4e00\u7ec4\u7ec7\u5168\u56fd\u836f\u54c1\u6ce8\u518c\u68c0\u67e5\u8d44\u6e90\u5b9e\u65bd\u73b0\u573a\u68c0\u67e5\uff0c\u5e76\u4e0d\u518d\u5217\u51652015\u5e747\u6708\u4ee5\u6765\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5f00\u5c55\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u81ea\u67e5\u6838\u67e5\u8303\u56f4\u3002\u201d\u96c6\u4e2d\u53d7\u7406\u524d\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u4f9d\u7136\u5c5e\u4e8e2015\u5e747\u6708\u4ee5\u6765\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5f00\u5c55\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u81ea\u67e5\u6838\u67e5\u8303\u56f4\u3002<\/p>\n\n\n\n

68<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5173\u4e8e\u539f\u8f85\u5305\u5173\u8054\u7533\u62a5\u7684\u5236\u5242\u7533\u8bf7\u8868\u586b\u62a5\u95ee\u9898<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u7533\u8bf7\u4eba\u5e94\u5728\u5236\u5242\u7533\u8bf7\u8868\u201c\u540c\u54c1\u79cd\u5df2\u88ab\u53d7\u7406\u6216\u540c\u671f\u7533\u62a5\u7684\u539f\u6599\u836f\u3001\u5236\u5242\u6216\u4e0d\u540c\u89c4\u683c\u54c1\u79cd\u201d  \u9879\u586b\u5199\u8be5\u5236\u5242\u5df2\u88ab\u53d7\u7406\u6216\u5173\u8054\u5ba1\u6279\u7684\u539f\u6599\u836f\u3001\u8f85\u6599\u3001\u836f\u5305\u6750\u3001\u5236\u5242\u6216\u4e0d\u540c\u89c4\u683c\u54c1\u79cd\u7684\u53d7\u7406\u53f7\/\u767b\u8bb0\u53f7\u53ca\u540d\u79f0\u3002\u5b8c\u6210\u4e34\u5e8a\u7814\u7a76\u7533\u8bf7\u4e0a\u5e02\u7684\u7533\u8bf7\uff0c\u8fd8\u9700\u586b\u5199\u539f\u4e34\u5e8a\u7533\u8bf7\u53d7\u7406\u53f7\u3001\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\u53f7\u3001\u4e34\u5e8a\u8bd5\u9a8c\u767b\u8bb0\u53f7\u6216\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5907\u6848\u53f7\u7b49\u3002<\/p>\n\n\n\n

69<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u7528\u4e8e\u808c\u8089\u6ce8\u5c04\u7684\u72c2\u72ac\u75c5\u4eba\u514d\u75ab\u7403\u86cb\u767d2\u6b65\u75c5\u6bd2\u706d\u6d3b\u5de5\u827a\u662f\u5426\u5fc5\u9700\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u73b0\u6709\u6307\u5bfc\u539f\u5219\u8981\u6c42\uff0c\u9700\u8981\u91c7\u75282\u6b65\u75c5\u6bd2\u706d\u6d3b\u5de5\u827a\u3002<\/p>\n\n\n\n

70<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u73b0\u884c\u300a\u751f\u7269\u5236\u54c1\u751f\u4ea7\u5de5\u827a\u8fc7\u7a0b\u53d8\u66f4\u7ba1\u7406\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\u4e3a2005\u5e74\u9881\u5e03\u7684\uff0c\u6709\u5173\u751f\u7269\u5236\u54c1\u751f\u4ea7\u5de5\u827a\u8fc7\u7a0b\u53d8\u66f4\u662f\u5426\u6709\u5176\u4ed6\u6307\u5bfc\u539f\u5219\u53ef\u4ee5\u53c2\u8003\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6709\u5173\u751f\u7269\u5236\u54c1\u751f\u4ea7\u5de5\u827a\u8fc7\u7a0b\u53d8\u66f4\u53ef\u53c2\u8003ICH Q5E\u6307\u5357\u3002<\/p>\n\n\n\n

71<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6309\u751f\u7269\u5236\u54c11\u7c7b\u7533\u62a5\u7684\u54c1\u79cd\uff0c\u53d6\u5f97\u4e34\u5e8a\u6279\u4ef6\u540e\u2160\u671f\u4e34\u5e8a\u6837\u54c1\u751f\u4ea7\u65f6\u53ef\u5426\u66f4\u6362\u57f9\u517b\u57fa\u7684\u751f\u4ea7\u5382\u5bb6\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u73b0\u6709\u6307\u5bfc\u539f\u5219\u8981\u6c42\uff0c\u5982\u9700\u66f4\u6362\u57f9\u517b\u57fa\u7684\u751f\u4ea7\u5382\u7533\u8bf7\u4eba\u5e94\u91cd\u65b0\u7533\u62a5\u3002<\/p>\n\n\n\n

72<\/strong><\/p>\n\n\n\n

\u95ee\uff1aBE\u8bd5\u9a8c\u4e2d\u7531\u4e8e\u5973\u6027\u53d7\u8bd5\u8005\u62db\u52df\u56f0\u96be\uff0c\u53ef\u5426\u4ec5\u91c7\u7528\u7537\u6027\u53d7\u8bd5\u8005\u8fdb\u884cBE\u8bd5\u9a8c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\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\u300b\u6307\u5bfc\u539f\u5219\u5bf9\u4e8e\u53d7\u8bd5\u8005\u7684\u89c4\u5b9a\uff1a\u5e94\u6db5\u76d6\u4e00\u822c\u4eba\u7fa4\u7684\u7279\u5f81\uff0c\u5305\u62ec\u5e74\u9f84\u3001\u6027\u522b\u7b49\u3002\u5982\u679c\u7814\u7a76\u836f\u7269\u62df\u7528\u4e8e\u4e24\u79cd\u6027\u522b\u7684\u4eba\u7fa4\uff0c\u4e00\u822c\u60c5\u51b5\u4e0b\uff0c\u53d7\u8bd5\u8005\u5e94\u6709\u9002\u5f53\u7684\u6027\u522b\u6bd4\u4f8b\u3002<\/p>\n\n\n\n

73<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u300a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5173\u4e8e\u5316\u5b66\u836f\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5b9e\u884c\u5907\u6848\u7ba1\u7406\u7684\u516c\u544a\u300b\uff082015\u5e74\u7b2c257\u53f7\uff09\u4e2d\u201c\u6ce8\u518c\u7533\u8bf7\u4eba\u5f00\u5c55\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u524d30\u5929\uff0c\u5e94\u5f53\u5728\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u6307\u5b9a\u7684\u5316\u5b66\u836fBE\u8bd5\u9a8c\u5907\u6848\u4fe1\u606f\u5e73\u53f0\u8fdb\u884c\u5316\u5b66\u836fBE\u8bd5\u9a8c\u5907\u6848\uff0c\u6309\u8981\u6c42\u63d0\u4ea4\u5907\u6848\u8d44\u6599\u201d\u4e2d\uff0c30\u5929\u662f\u81ea\u7136\u65e5\u8fd8\u662f\u5de5\u4f5c\u65e5\uff1f\u7533\u8bf7\u4eba\u5728\u83b7\u5f97\u5907\u6848\u53f7\u540e30\u5929\uff0c\u5982\u603b\u5c40\u65e0\u610f\u89c1\u5373\u53ef\u81ea\u884c\u5f00\u5c55BE\u8bd5\u9a8c\u5417\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u300a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5173\u4e8e\u5316\u5b66\u836f\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5b9e\u884c\u5907\u6848\u7ba1\u7406\u7684\u516c\u544a\u300b\uff082015\u5e74\u7b2c257\u53f7\uff09\u4e2d\u5173\u4e8e\u5907\u6848\u65f6\u95f4\u768430\u5929\u8981\u6c42\u4e3a\u81ea\u7136\u65e5\uff0c\u5907\u6848\u6210\u529f\u5e76\u83b7\u5f97\u5907\u6848\u53f730\u5929\u540e\u4f01\u4e1a\u5373\u53ef\u81ea\u884c\u5f00\u5c55\u8bd5\u9a8c\u3002<\/p>\n\n\n\n

74<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u8fdb\u53e3\u836f\u7684BE\u8bd5\u9a8c\u662f\u5426\u53ef\u4ee5\u5728BE\u5907\u6848\u5e73\u53f0\u8fdb\u884c\u5907\u6848\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u7b26\u5408\u300a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5173\u4e8e\u5316\u5b66\u836f\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5b9e\u884c\u5907\u6848\u7ba1\u7406\u7684\u516c\u544a\u300b\uff082015\u5e74\u7b2c257\u53f7\uff09\u89c4\u5b9a\u8303\u56f4\u7684\u8fdb\u53e3\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u53ef\u4ee5\u8fdb\u884cBE\u5907\u6848\u3002<\/p>\n\n\n\n

75<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u6ce8\u518c\u7533\u8bf7\u5ba1\u8bc4\u671f\u95f4\u5982\u4f55\u7533\u8bf7\u64a4\u56de\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u56fd\u4ea7\u6ce8\u518c\u7533\u8bf7\u5e94\u8bf7\u5411\u7701\u5c40\u63d0\u51fa\u64a4\u56de\u7533\u8bf7\uff0c\u7531\u7701\u5c40\u628a\u64a4\u56de\u7533\u8bf7\u548c\u7701\u5c40\u610f\u89c1\u5355\u4e00\u5e76\u8f6c\u9001\u836f\u5ba1\u4e2d\u5fc3\uff1b\u8fdb\u53e3\u6ce8\u518c\u7533\u8bf7\u5e94\u5411\u603b\u5c40\u63d0\u51fa\u64a4\u56de\u7533\u8bf7\uff0c\u7531\u603b\u5c40\u628a\u64a4\u56de\u7533\u8bf7\u8f6c\u836f\u5ba1\u4e2d\u5fc3\u3002<\/p>\n\n\n\n

76<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u4e3a\u517c\u987e\u516c\u5e73\u548c\u6548\u7387\uff0c\u836f\u5ba1\u4e2d\u5fc3\u5bf9\u6ce8\u518c\u7533\u8bf7\u5b9e\u65bd\u540c\u54c1\u79cd\u96c6\u4e2d\u5ba1\u8bc4\u548c\u6309\u8fdb\u4e2d\u5fc3\u65f6\u95f4\u5148\u540e\u987a\u5e8f\u653e\u884c\u7684\u7ba1\u7406\u65b9\u5f0f\uff0c\u5ba1\u8bc4\u56e2\u961f\u53ef\u4e0d\u6309\u7533\u62a5\u987a\u5e8f\u5b9e\u65bd\u54c1\u79cd\u96c6\u4e2d\u5ba1\u8bc4\uff0c\u5b8c\u6210\u5ba1\u8bc4\u540e\u7531\u4e1a\u52a1\u7ba1\u7406\u5904\u6309\u540c\u5ba1\u8bc4\u5e8f\u5217\u6ce8\u518c\u7533\u8bf7\u7684\u7533\u62a5\u65f6\u95f4\u987a\u5e8f\u5236\u4f5c\u9001\u7b7e\u6587\u4ef6\u548c\u653e\u884c\u3002\u56e0\u6b64\uff0c\u7533\u62a5\u65f6\u95f4\u9760\u540e\u4f46\u5148\u5b8c\u6210\u5ba1\u8bc4\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u9700\u7b49\u5f85\u6392\u5728\u5176\u524d\u9762\u7684\u4efb\u52a1\u5b8c\u6210\u540e\u624d\u80fd\u8f6c\u5165\u4e0b\u4e00\u73af\u8282\u3002\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\u7684\u6ce8\u518c\u7533\u8bf7\u4e0d\u53d7\u6309\u5e8f\u653e\u884c\u7684\u9650\u5236\uff0c\u5404\u73af\u8282\u5747\u5e94\u7b2c\u4e00\u65f6\u95f4\u5904\u7406\u3002<\/p>\n\n\n\n

77<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u7b2c\u4e00\u6b21\u63d0\u4ea4\u8865\u5145\u7533\u8bf7\u65f6\u4e0d\u8981\u6c42\u5fc5\u987b\u63d0\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff0c\u7ecf\u5ba1\u8bc4\u540e\u5982\u9700\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\uff0c\u7531\u836f\u5ba1\u4e2d\u5fc3\u53d1\u51fa\u4e34\u5e8a\u6279\u4ef6\uff0c\u7533\u8bf7\u4eba\u53ef\u5728\u83b7\u5f97\u4e34\u5e8a\u6279\u4ef6\u540e\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5b8c\u6210\u4e34\u5e8a\u8bd5\u9a8c\u540e\u6309\u7167\u8865\u5145\u7533\u8bf7\u518d\u6b21\u7533\u62a5\u3002<\/p>\n\n\n\n

78<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u4e2d\u836f\u4e2d\u8bd5\u7814\u7a76\u6837\u54c1\u7684\u5236\u5907\u662f\u5426\u9700\u8981\u5728\u6709GMP\u8bc1\u4e66\u7684\u8f66\u95f4\u751f\u4ea7\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5bf9\u4e2d\u8bd5\u6837\u54c1\u5236\u5907\u7684\u8f66\u95f4\uff0c\u4e0d\u8981\u6c42\u5fc5\u987b\u6709GMP\u8bc1\u4e66\u3002<\/p>\n\n\n\n

79<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u4e2d\u836f\u5236\u5242\u53ef\u5426\u7528\u8865\u5145\u7533\u8bf7\u65b9\u5f0f\u5728\u539f\u6709\u7cd6\u578b\u5236\u5242\u57fa\u7840\u4e0a\u589e\u52a0\u65e0\u7cd6\u578b\u89c4\u683c\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4e2d\u836f\u5236\u5242\u6709\u7cd6\u578b\u6539\u4e3a\u65e0\u7cd6\u578b\u5c5e\u4e8e\u8f85\u6599\u7684\u53d8\u66f4\uff0c\u4e0d\u5c5e\u4e8e\u589e\u52a0\u89c4\u683c\uff0c\u4e24\u8005\u53ea\u80fd\u4fdd\u7559\u5176\u4e00\uff0c\u4e0d\u80fd\u901a\u8fc7\u8865\u5145\u7533\u8bf7\u9014\u5f84\u589e\u52a0\u3002<\/p>\n\n\n\n

80<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u4e34\u5e8a\u6838\u67e5\u6309\u7167\u603b\u5c40\u300a\u5173\u4e8e\u5370\u53d1\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6838\u67e5\u5de5\u4f5c\u7a0b\u5e8f\uff08\u6682\u884c\uff09\u7684\u901a\u77e5\u300b(\u98df\u836f\u76d1\u836f\u5316\u7ba1\u30142016\u301534\u53f7)\u6267\u884c\u3002\u836f\u5ba1\u4e2d\u5fc3\u5b9a\u671f\u5411\u603b\u5c40\u6838\u67e5\u4e2d\u5fc3\u66f4\u65b0\u9700\u8981\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6838\u67e5\u7684\u6ce8\u518c\u7533\u8bf7\u540d\u5355\uff0c\u5176\u4e2d\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\u7684\u5efa\u8bae\u4f5c\u4e3a\u7b2c\u4e00\u4f18\u5148\u7ea7\u5b89\u6392\u6838\u67e5\uff0c\u5df2\u7ecf\u5b8c\u6210\u5404\u9879\u5ba1\u8bc4\u5de5\u4f5c\u7b49\u5f85\u6c47\u603b\u4e34\u5e8a\u6838\u67e5\u7ed3\u679c\u7684\u5efa\u8bae\u4f5c\u4e3a\u7b2c\u4e8c\u4f18\u5148\u7ea7\u5b89\u6392\u6838\u67e5\uff0c\u5176\u4ed6\u6ce8\u518c\u7533\u8bf7\u5219\u6309\u5e8f\u6838\u67e5\uff1b\u540c\u4e00\u4f18\u5148\u7ea7\u7684\u6ce8\u518c\u7533\u8bf7\u5219\u5efa\u8bae\u6309\u7167\u6ce8\u518c\u7533\u8bf7\u8f6c\u5165\u836f\u5ba1\u4e2d\u5fc3\u7684\u65f6\u95f4\u5148\u540e\u987a\u5e8f\u5b89\u6392\u6838\u67e5\u3002<\/p>\n\n\n\n

81<\/strong><\/p>\n\n\n\n

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\u89e3\u7b54\uff1a<\/strong>\u7533\u8bf7\u4eba\u5e94\u5728\u8865\u5145\u8d44\u6599\u89c4\u5b9a\u7684\u671f\u9650\u5185\u5411\u836f\u5ba1\u4e2d\u5fc3\u63d0\u4ea4\u9664\u68c0\u9a8c\u62a5\u544a\uff08\u8d28\u91cf\u590d\u6838\u62a5\u544a\u6216\u68c0\u9a8c\u62a5\u544a\uff09\u4ee5\u5916\u7684\u5176\u4ed6\u8d44\u6599\u3001\u836f\u54c1\u68c0\u9a8c\u673a\u6784\u6837\u54c1\u63a5\u6536\u5355\uff0c\u68c0\u9a8c\u62a5\u544a\u7531\u68c0\u9a8c\u673a\u6784\u5728\u5b8c\u6210\u68c0\u9a8c\u5de5\u4f5c\u540e\u62a5\u9001\u836f\u5ba1\u4e2d\u5fc3\uff0c\u836f\u5ba1\u4e2d\u5fc3\u4f1a\u5728\u6536\u5230\u8d28\u91cf\u590d\u6838\u62a5\u544a\u6216\u68c0\u9a8c\u62a5\u544a\u540e\u542f\u52a8\u5ba1\u8bc4\u4efb\u52a1\u3002<\/p>\n\n\n\n

82<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5982\u4f55\u5728\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u8865\u5145\u7a33\u5b9a\u6027\u7814\u7a76\u8d44\u6599\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5bf9\u5c1a\u672a\u5b8c\u6210\u5ba1\u8bc4\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u901a\u8fc7\u516c\u6587\u65b9\u5f0f\u5411\u836f\u5ba1\u4e2d\u5fc3\u8865\u5145\u63d0\u4ea4\u7a33\u5b9a\u6027\u7814\u7a76\u6570\u636e\uff1b\u5bf9\u5df2\u5b8c\u6210\u5ba1\u8bc4\u7684\u54c1\u79cd\uff0c\u4e0d\u518d\u63a5\u6536\u6b64\u7c7b\u8d44\u6599\u3002<\/p>\n\n\n\n

83<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5982\u4f55\u53d8\u66f4\u5f85\u5ba1\u8bc4\u6ce8\u518c\u7533\u8bf7\u7684\u8054\u7cfb\u4eba\u3001\u516c\u53f8\u540d\u79f0\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u98df\u54c1\u836f\u54c1\u76d1\u7ba1\u603b\u5c40\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u6ce8\u518c\u53d7\u7406\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff08\u98df\u836f\u76d1\u836f\u5316\u7ba1\u30142015\u3015122\u53f7  \uff09  \uff0c\u5728\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u7684\u7533\u8bf7\u4eba\u673a\u6784\u66f4\u540d\uff08\u4e3b\u4f53\u4e0d\u53d8\uff09\u3001\u8054\u7cfb\u65b9\u5f0f\u53d8\u66f4\uff08\u4ec5\u9650\u4e8e\u7533\u8bf7\u4eba\u8054\u7cfb\u7535\u8bdd\u3001\u4f20\u771f\u3001\u7535\u5b50\u90ae\u7bb1\u5730\u5740\u7684\u53d8\u66f4\uff09\u3001\u6ce8\u518c\u5730\u5740\u53d8\u66f4\uff08\u4e0d\u6539\u53d8\u751f\u4ea7\u5730\u5740\uff09\u3001\u62df\u4f7f\u7528\u7684\u5546\u54c1\u540d\u79f0\u589e\u52a0\u6216\u6539\u53d8\u7684\uff0c\u7531\u539f\u53d7\u7406\u90e8\u95e8\uff08\u7701\u5c40\u6ce8\u518c\u5904\u6216\u603b\u5c40\u53d7\u7406\u4e2d\u5fc3\uff09\u5ba1\u6838\u540e\u901a\u77e5\u836f\u54c1\u6280\u672f\u5ba1\u8bc4\u90e8\u95e8\u3002<\/p>\n\n\n\n

84<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u7533\u8bf7\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\u7684\u8fdb\u5ea6\u4ee5\u53ca\u7a0b\u5e8f\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u6839\u636e\u300a\u603b\u5c40\u5173\u4e8e\u53d1\u5e03\u836f\u7269\u7814\u53d1\u4e0e\u6280\u672f\u5ba1\u8bc4\u6c9f\u901a\u4ea4\u6d41\u7ba1\u7406\u529e\u6cd5\uff08\u8bd5\u884c\uff09\u300b\uff082016\u5e74\u7b2c94\u53f7\uff09\uff0c\u7533\u8bf7\u4eba\u53ef\u901a\u8fc7\u836f\u5ba1\u4e2d\u5fc3\u7f51\u7ad9\u201c\u7533\u8bf7\u4eba\u4e4b\u7a97\u201d\u63d0\u4ea4\u201c\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\u57fa\u672c\u4fe1\u606f\u8868\u201d\u53ca\u201c\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\u8d44\u6599\u201d\uff0c\u836f\u5ba1\u4e2d\u5fc3\u9879\u76ee\u7ba1\u7406\u4eba\u8d1f\u8d23\u7ec4\u7ec7\u4f1a\u8bae\u7533\u8bf7\u7684\u5ba1\u6838\u3001\u7b79\u5907\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\uff0c\u786e\u5b9a\u65e5\u671f\u3001\u5730\u70b9\u3001\u5185\u5bb9\u3001\u53c2\u4f1a\u4eba\u5458\u7b49\u4fe1\u606f\u3002<\/p>\n\n\n\n

85<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u5f85\u5ba1\u8bc4\u54c1\u79cd\u5c5e\u4e8e\u5e94\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u81ea\u67e5\u6838\u67e5\u8303\u56f4\u7684\uff0c\u4f46\u201c\u7533\u8bf7\u4eba\u4e4b\u7a97\u201d\u672a\u6807\u8bb0\u9700\u4e34\u5e8a\u8bd5\u9a8c\u6838\u67e5\uff0c\u4e5f\u672a\u7eb3\u5165\u603b\u5c40\u516c\u544a\uff0c\u8be5\u5982\u4f55\u5904\u7406\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u53d1\u73b0\u6b64\u7c7b\u60c5\u51b5\uff0c\u7533\u8bf7\u4eba\u53ef\u901a\u8fc7\u201c\u7533\u8bf7\u4eba\u4e4b\u7a97\u201d\u4e00\u822c\u6027\u6280\u672f\u95ee\u9898\u54a8\u8be2\u901a\u9053\u63d0\u51fa\uff0c\u6216\u90ae\u4ef6\u5411\u9879\u76ee\u7ba1\u7406\u4eba\u53cd\u6620\uff0c\u6216\u5411\u836f\u5ba1\u4e2d\u5fc3\u63d0\u4ea4\u516c\u6587\u8bf4\u660e\u3002<\/p>\n\n\n\n

86<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u300a\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u5173\u4e8e\u8c03\u6574\u90e8\u5206\u836f\u54c1\u884c\u653f\u5ba1\u6279\u4e8b\u9879\u5ba1\u6279\u7a0b\u5e8f\u7684\u51b3\u5b9a\u300b\uff08\u603b\u5c40\u4ee4\u7b2c31\u53f7\uff09\u53d1\u5e03\u540e\uff0c\u518d\u6ce8\u518c\u671f\u95f4\u7684\u4e34\u65f6\u8fdb\u53e3\u662f\u5426\u4e5f\u7531\u836f\u5ba1\u4e2d\u5fc3\u5ba1\u6279\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4e34\u65f6\u8fdb\u53e3\u7533\u8bf7\u4e0d\u5c5e\u4e8e\u603b\u5c4031\u53f7\u6587\u8c03\u6574\u5ba1\u6279\u7a0b\u5e8f\u7684\u8303\u56f4\uff0c\u5e94\u6309\u539f\u7a0b\u5e8f\u7533\u62a5\u548c\u5ba1\u6279\u3002<\/p>\n\n\n\n

87<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u53e3\u670d\u56fa\u4f53\u5236\u5242\u4ea7\u54c1\u5df2\u83b7\u5f97\u4e34\u5e8a\u6279\u4ef6\uff0c\u5df2\u5b8c\u6210\u5de5\u827a\u6539\u8fdb\u7b49\u7814\u7a76\u5de5\u4f5c\uff0c\u73b0\u62df\u5f00\u5c55\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\uff0c\u662f\u5426\u5fc5\u987b\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5907\u6848\u540e\u624d\u80fd\u5f00\u5c55\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u5df2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\u4e14\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\u5728\u6709\u6548\u671f\u5185\u7684\uff0c\u53ef\u76f4\u63a5\u5f00\u5c55\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\uff0c\u4e0d\u5fc5\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5907\u6848\u3002<\/p>\n\n\n\n

88<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u56fd\u5185\u9996\u5bb6\u54c1\u79cd\u62a5\u751f\u4ea7\u65f6\u80fd\u5426\u7533\u62a5\u5546\u54c1\u540d\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u836f\u54c1\u5546\u54c1\u540d\u7684\u7533\u62a5\u5e94\u7b26\u5408\u300a\u5173\u4e8e\u8fdb\u4e00\u6b65\u89c4\u8303\u836f\u54c1\u540d\u79f0\u7ba1\u7406\u7684\u901a\u77e5\u300b\uff08\u56fd\u98df\u836f\u76d1\u6ce8[2006]99\u53f7\uff09\u7684\u8981\u6c42\u3002<\/p>\n\n\n\n

89<\/strong><\/p>\n\n\n\n

\u95ee\uff1a\u4e34\u5e8a\u8bd5\u9a8c\u6837\u54c1\u3001\u5bf9\u7167\u54c1\u7684\u5236\u5907\u3001\u9009\u62e9\u4e0e\u68c0\u9a8c\u6709\u4ec0\u4e48\u8981\u6c42\uff1f<\/strong><\/p>\n\n\n\n

\u89e3\u7b54\uff1a<\/strong>\u4e34\u5e8a\u8bd5\u9a8c\u6837\u54c1\u5e94\u6309\u7167GCP\u4e2d\u5bf9\u8bd5\u9a8c\u836f\u7269\u7ba1\u7406\u76f8\u5173\u6761\u6b3e\u53ca\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\uff0828\u53f7\u4ee4\uff09\u7b2c36\u6761\u89c4\u5b9a\u6267\u884c\u3002<\/p>\n\n\n\n

90<\/strong><\/p>\n\n\n\n

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