{"id":2001,"date":"2021-03-26T19:43:14","date_gmt":"2021-03-26T11:43:14","guid":{"rendered":"https:\/\/damakey.com\/?p=2001"},"modified":"2023-05-26T11:42:35","modified_gmt":"2023-05-26T03:42:35","slug":"%e5%90%83%e8%97%a5%e5%89%8d%ef%bc%8c%e4%bd%a0%e5%bf%85%e9%a0%88%e7%9f%a5%e9%81%93%e7%9a%84%e4%ba%8b","status":"publish","type":"post","link":"https:\/\/damakey.com\/?p=2001","title":{"rendered":"\u5403\u85e5\u524d\uff0c\u4f60\u5fc5\u9808\u77e5\u9053\u7684\u4e8b"},"content":{"rendered":"

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\u300e\u897f\u85e5\u7684\u7528\u85e5\u7406\u8ad6\uff0c\u5247\u662f\u5c07\u6709\u6548\u7684\u300c\u5916\u4f86\u7269\u300d\u7d93\u904e\u7be9\u9078\u904e\u7a0b\u53bb\u856a\u5b58\u83c1\uff0c\u5f97\u5230\u6709\u5be6\u8b49\u7684\u300c\u539f\u6599\u85e5<\/span>(active pharmaceutical ingredient, API)<\/span>\uff0c\u800c\u539f\u6599\u85e5\u518d\u7d93\u904e\u589e\u6548\u6e1b\u6bd2\u7684\u914d\u65b9\u512a\u5316\uff0c\u5f97\u5230\u8868\u73fe\u6700\u4f73\uff0c\u53ef\u4ee5\u4f9b\u4eba\u4f7f\u7528\u7684\u300c\u85e5\u300d<\/span>(finish product)<\/span>\uff0c\u5167\u884c\u4eba\u91dd\u5c0d\u65b0\u767c\u73fe\u6709\u751f\u7269\u6d3b\u6027\u7684\u5916\u4f86\u7269\u901a\u5e38\u7a31\u70ba\u300c\u65b0\u7269\u8cea\u300d<\/span>(new chemical entity)<\/span>\uff0c\u53ea\u6709\u53d6\u5f97\u85e5\u54c1\u8a31\u53ef\u8b49\uff0c\u53ef\u4f9b\u4eba\u4f7f\u7528\u65bc\u6cbb\u75c5\u7684\u7522\u54c1\u624d\u53ef\u7a31\u70ba\u300c\u85e5\u300d<\/span>(drug, medicine)<\/span>\u3002<\/span>……<\/span>\u300f<\/span>*<\/span><\/p>\n

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

\u300e\u7b2c\u4e00\u500b\u88ab\u767c\u660e\u3001\u5177\u6709\u85e5\u6548\u7684\u7269\u8cea\uff0c\u7a31\u70ba\u300c\u65b0\u7269\u8cea\u300d\u3002\u9019\u4e9b\u901a\u5e38\u300c\u6709\u65b0\u7a4e\u6027\u3001\u9032\u6b65\u6027\u3001\u5177\u6709\u7522\u696d\u50f9\u503c\u3001\u53ef\u589e\u9032\u4eba\u985e\u798f\u7949\u300d\u7684\u65b0\u7269\u8cea\uff0c\u662f\u88ab\u6838\u7d66\u767c\u660e\u5c08\u5229\u7684\u8981\u7d20\uff0c\u5b83\u5011\u5728\u52d5\u7269\u5be6\u9a57\u4e2d\u88ab\u8b49\u660e\u5b89\u5168\u7121\u865e\u4e14\u5177\u6709\u85e5\u6548\uff0c\u53ef\u5411\u4e3b\u7ba1\u6a5f\u69cb\u7533\u8acb\u9032\u884c\u81e8\u5e8a\u8a66\u9a57\uff0c\u6210\u70ba\u300c\u81e8\u5e8a\u8a66\u9a57\u65b0\u85e5\u300d<\/span>(Investigational New Drug, IND)<\/span>\uff1b\u81f3\u65bc\u672a\u4e0a\u81e8\u5e8a\u8a66\u9a57\u7684\u300c\u65b0\u7269\u8cea\u300d\u6216\u300c\u81e8\u5e8a\u8a66\u9a57\u65b0\u85e5\u300d\uff0c\u5247\u4e0d\u5c6c\u65bc\u300c\u65b0\u85e5\u300d\u3002<\/span><\/p>\n

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

\u7b49\u65b0\u7269\u8cea\u505a\u5b8c\u81e8\u5e8a\u8a66\u9a57\uff0c\u901a\u904e\u4e3b\u7ba1\u6a5f\u95dc\u7684\u5c08\u5bb6\u8a55\u4f30<\/span>(risk-benefit assessment)<\/span>\uff0c\u4fbf\u53ef\u7533\u8acb\u4e0a\u5e02\u8a31\u53ef<\/span>(New Drug Application, NGA)<\/span>\uff0c\u6210\u70ba\u300c\u65b0\u85e5\u300d\u3002\u300c\u65b0\u85e5\u300d\u4e0a\u5e02\u5f8c\uff0c\u4ecd\u5fc5\u9808\u6536\u96c6\u75c5\u4eba\u4f7f\u7528\u7684\u81e8\u5e8a\u8b49\u64da\uff0c\u9032\u884c\u56de\u5831\u3001\u8ffd\u67e5\u53ca\u76e3\u8996\uff0c\u56e0\u6b64\u570b\u5167\u300c\u65b0\u85e5\u300d\u7684\u6cd5\u5b9a\u540d\u7a31\u53eb\u505a\u300c\u76e3\u8996\u4e2d\u7684\u65b0\u85e5\u300d\u3002<\/span><\/p>\n

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

\u4e00\u822c\u4f86\u8aaa\uff0c\u7b2c\u4e00\u500b\u4e0a\u5e02\u7684\u65b0\u85e5\u7a31\u70ba\u300c\u539f\u5ee0\u85e5\u300d\uff0c\u7b49\u904e\u4e86\u5c08\u5229\u671f\u7684\u4fdd\u8b77\uff0c\u5247\u7a31\u70ba\u300c\u5b78\u540d\u85e5\u300d\u3002\u539f\u5ee0\u85e5\u904e\u4e86\u5c08\u5229\u4fdd\u8b77\u671f\uff0c\u300c\u65b0\u85e5\u300d\u5c31\u6703\u8b8a\u6210\u7b2b\u4e00\u500b\u5b78\u540d\u85e5\uff0c\u4e26\u5931\u53bb\u5e02\u5834\u7368\u8ce3\u7684\u6b0a\u5229\uff0c\u9019\u6642\u5176\u4ed6\u85e5\u5ee0\u53ef\u4ee5\u51fa\u7522\u76f8\u540c\u54c1\u8cea\u8207\u85e5\u6548\u7684\u5b78\u540d\u85e5\u3002<\/span><\/p>\n

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

\u7531\u65bc\u85e5\u54c1\u54c1\u8cea\u6703\u5f71\u97ff\u85e5\u6548\uff0c\u5176\u4ed6\u5ee0\u724c\u7684\u5b78\u540d\u85e5\u5fc5\u9808\u900f\u904e\u56b4\u8b39\u7684\u79d1\u5b78\u5be6\u8b49\uff0c\u5728\u540c\u4e00\u4f4d\u53d7\u8a66\u8005\u8eab\u4e0a\uff0c\u8b49\u660e\u5b83\u8206\u539f\u5ee0\u5b78\u540d\u85e5\u5177\u6709\u7d71\u8a08\u5b78\u610f\u7fa9\u7684\u9ad4\u5167\u76f8\u7b49\u6027<\/span>(drug A is equivalent to drug B in biological system)<\/span>\uff0c\u7a31\u4e4b\u70ba\u300c<\/span>BE<\/span>\u5b78\u540d\u85e5\u300c<\/span>(bio-equivalent drug, BE)<\/span>\u3002<\/span>……<\/span>\u300f<\/span>*<\/span><\/p>\n

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

\u5f9e\u9019\u88e1\uff0c\u6211\u5011\u53ef\u4ee5\u898f\u7d0d\u5e7e\u500b\u7d50\u8ad6\uff1a<\/span><\/p>\n

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1. <\/span>\u300c\u65b0\u85e5\u300d\u662f\u6709\u85e5\u6548\u7684\u300c\u65b0\u7269\u8cea\u300d\u7d93\u904e\u589e\u6548\u3001\u6e1b\u6bd2\u3001\u81e8\u5e8a\u8a66\u9a57\u4e4b\u5f8c\u4e0a\u5e02\u7684\u3002\u4f46\u57fa\u672c\u4e0a\u9084\u662f\u6709\u300c\u6bd2\u300d\u7684\u3002\u800c\u4e14\u81e8\u5e8a\u8a66\u9a57\u53ef\u80fd\u6c92\u6709\u8fa6\u6cd5\u6e2c\u8a66\u5230\u5404\u7a2e\u72c0\u6cc1\uff0c\u5982\u4eba\u7a2e\u3001\u548c\u98df\u7269\u7684\u76f8\u4e92\u4f5c\u7528\u7b49\u7b49\uff0c\u521d\u671f\u4f7f\u7528\u300c\u65b0\u85e5\u300d\u53ef\u80fd\u6703\u6709\u4e0d\u53ef\u9810\u671f\u7684\u98a8\u96aa\u3002\u6240\u4ee5\uff0c\u4e26\u4e0d\u662f\u65b0\u4e0a\u5e02\u7684\u300c\u65b0\u85e5\u300d\u5c31\u662f\u5c31\u662f\u6bd4\u8f03\u597d\u7684\u3002<\/span><\/p>\n

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2. <\/span>\u300c\u65b0\u85e5\u300d\u4e0a\u5e02\u521d\u671f\u81e8\u5e8a\u4f7f\u7528\u7684\u72c0\u6cc1<\/span>(<\/span>\u7b2c\u56db\u968e\u6bb5\u81e8\u5e8a\u8cc7\u6599<\/span>)<\/span>\uff0c\u662f\u4f5c\u70ba\u300c\u65b0\u85e5\u300d\u662f\u5426\u53ef\u4ee5\u7e7c\u7e8c\u4e0a\u5e02\u4f7f\u7528\u7684\u91cd\u8981\u8a55\u4f30\u4f9d\u64da\u3002\u9019\u500b\u6642\u671f\u7684\u7528\u85e5\uff0c\u7b49\u65bc\u662f\u7528\u75c5\u4eba\u505a\u8a66\u9a57\uff0c\u75c5\u4eba\u9762\u5c0d\u7684\u98a8\u96aa\uff0c\u7b49\u65bc\u662f\u70ba\u672a\u4f86\u7684\u4f7f\u7528\u8005\u628a\u95dc\uff0c\u53ef\u8996\u70ba\u4e00\u7a2e\u300c\u516c\u5171\u8ca1\u300d\u3002\u9019\u4e5f\u662f\u70ba\u4ec0\u9ebc\u5c08\u5229\u4fdd\u8b77\u671f\u6709\u4e00\u5b9a\u7684\u6642\u9650\uff0c\u56e0\u70ba\u300c\u65b0\u85e5\u300d\u53ef\u4ee5\u7e7c\u7e8c\u4e0a\u5e02\uff0c\u7b2c\u56db\u968e\u6bb5\u81e8\u5e8a\u8cc7\u6599\u5c45\u529f\u751a\u5049\u3002<\/span><\/p>\n

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

3. <\/span>\u7d93\u7b2c\u56db\u968e\u81e8\u5e8a\u8cc7\u6599\u8a55\u4f30\u53ef\u7e7c\u7e8c\u4e0a\u5e02\u7684\u300c\u65b0\u85e5\u300d\u5728\u5c08\u5229\u4fdd\u8b77\u671f\u6eff\u4e4b\u5f8c\uff0c\u6703\u8f49\u70ba\u300c\u5b78\u540d\u85e5\u300d\uff0c\u5176\u4ed6\u85e5\u5ee0\u90fd\u53ef\u4eff\u88fd\u3002\u7814\u88fd\u300c\u65b0\u85e5\u300d\u662f\u8cc7\u672c\u5bc6\u96c6\u7684\u7522\u696d\uff0c\u4e00\u7a2e\u300c\u65b0\u85e5\u300d\u52d5\u8f12\u9700\u8981<\/span>8<\/span>\u5230<\/span>10<\/span>\u5e74\uff0c\u6295\u8cc7\u9ad8\u9054<\/span>8<\/span>\u5104\u7f8e\u91d1\uff0c\u9019\u4e5f\u662f\u70ba\u4ec0\u9ebc\u4e00\u822c\u6703\u7d66\u5230\u9ad8\u9054<\/span>20<\/span>\u5e74\u7684\u5c08\u5229\uff0c\u4ee5\u52a0\u5f37\u85e5\u5ee0\u7814\u767c\u300c\u65b0\u85e5\u300d\u7684\u52d5\u529b\u3002<\/span><\/p>\n

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

4. <\/span>\u300c\u65b0\u85e5\u300d\u8b8a\u6210\u4e86\u300c\u5b78\u540d\u85e5\u300d\uff0c\u4e5f\u53eb\u300c\u539f\u5ee0\u85e5\u300d\u3002\u5176\u4ed6\u85e5\u5ee0\u4eff\u88fd\u7684\u300c\u5b78\u540d\u85e5\u300d\uff0c\u5fc5\u9808\u7d93\u8a66\u9a57\u5728\u7d71\u8a08\u4e0a\u8b49\u660e\u8207\u300c\u539f\u5ee0\u85e5\u300d\u6709\u9ad4\u5167\u76f8\u7b49\u6027\uff0c\u610f\u601d\u662f\u6548\u679c\u548c\u6bd2\u6027\u662f\u4e00\u6a23\u7684\u3002\u6240\u4ee5\uff0c\u4e0d\u8981\u8ff7\u4fe1\u300c\u539f\u5ee0\u85e5\u300d\u662f\u6bd4\u8f03\u597d\u3002\u300c\u5b78\u540d\u85e5\u300d\u662f\u4e00\u6a23\u7684\u597d\uff0c\u800c\u4e14\u5f80\u5f80\u6bd4\u8f03\u4fbf\u5b9c\uff0c\u53ef\u4ee5\u8aaa\u662f\u7269\u5ec9\u50f9\u7f8e\u5594\uff01<\/span><\/p>\n

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

\u9019\u4e9b\u662f\u7528\u85e5\u5f88\u91cd\u8981\u7684\u6982\u5ff5\u3002<\/span><\/p>\n

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

\u85e5\u5c31\u662f\u6bd2\u3002\u53f0\u7063\u4eba\u4ee5\u559c\u6b61\u5403\u5404\u7a2e\u88dc\u54c1\u548c\u85e5\u54c1\u805e\u540d\u65bc\u4e16\uff0c\u800c\u91ab\u7642\u9662\u6240\u4ee5\u85e5\u990a\u91ab\u7684\u7b56\u7565\u4e5f\u6a02\u5f97\u914d\u5408\u6f14\u51fa\uff0c\u4ee5\u81f3\u65bc\u5c0d\u814e\u81df\u9020\u6210\u56b4\u91cd\u7684\u8ca0\u64d4\uff0c\u814e\u81df\u75c5\u672b\u671f\u767c\u751f\u7387\u4e16\u754c\u7b2c\u4e00\uff0c\u7531\u5168\u6c11\u5065\u4fdd\u5168\u984d\u88dc\u52a9\u7684\u6d17\u814e\uff0c\u6bcf\u5e74\u8981\u82b1\u5230\u5c07\u8fd1\u65b0\u53f0\u5e63<\/span>400<\/span>\u5104\u5143\uff01<\/span><\/p>\n

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

\u300e\u7f8e\u570b\u814e\u81df\u767b\u9304\u7cfb\u7d71<\/span>(USRDS)<\/span>\u767c\u5e03\u7684<\/span>2018<\/span>\u5e74\u5831\u6307\u51fa\uff0c<\/span>2016<\/span>\u5e74\u53f0\u7063\u570b\u4eba\u672b\u671f\u814e\u81df\u75c5\u767c\u751f\u7387\u3001\u76db\u884c\u7387\u5747\u70ba\u4e16\u754c\u7b2c\u4e00\u3002\u7acb\u6cd5\u9662\u9810\u7b97\u4e2d\u5fc3\u8fd1\u65e5\u63d0\u51fa\u5831\u544a\u9810\u8b66\uff0c\u53f0\u7063\u6d17\u814e\u4eba\u6578\u5728<\/span>10<\/span>\u5e74\u5167\u589e\u52a0<\/span>2<\/span>\u842c\u591a\u4eba\uff0c\u5230<\/span>2019<\/span>\u5e74\u5df2\u9054<\/span>9<\/span>\u842c<\/span>2624<\/span>\u4eba\uff0c\u5065\u4fdd\u70ba\u6b64\u9808\u652f\u51fa<\/span>393<\/span>\u5104\u5143\uff0c\u5e73\u5747\u6bcf\u4f4d\u6d17\u814e\u75c5\u60a3\u6bcf\u5e74\u652f\u51fa\u7d04<\/span>43<\/span>\u842c<\/span>(<\/span>\u5c1a\u672a\u8a08\u5165\u5176\u4ed6\u4f75\u767c\u75c7\u91ab\u7642\u8cbb\u7528<\/span>)<\/span>\uff0c\u5f62\u6210\u5065\u4fdd\u91cd\u5927\u8ca0\u64d4\u3002\u300f<\/span>**<\/span><\/p>\n

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

\u4e00\u65e6\u6d17\u814e\uff0c\u9664\u4e86\u5c0d\u5065\u4fdd\u9020\u6210\u8ca0\u64d4\uff0c\u66f4\u91cd\u8981\u7684\u662f\uff0c\u500b\u4eba\u7684\u751f\u6d3b\u54c1\u8cea\u6c34\u6e96\u5c31\u5f88\u56f0\u96e3\u7dad\u6301\u4e86\u3002\u552f\u6709\u5927\u5bb6\u5f9e\u6839\u672c\u8a8d\u8b58\u300c\u85e5\u300d\u5373\u662f\u300c\u6bd2\u300d\uff0c\u4e0d\u5c6c\u65bc\u8eab\u9ad4\u7684\u300c\u88dc\u85e5\u300d\u4e5f\u53ef\u80fd\u662f\u300c\u6bd2\u300d\uff0c\u50c5\u614e\u7528\u85e5\u5c11\u5403\u88dc\u54c1\uff0c\u624d\u6709\u53ef\u80fd\u626d\u8f49\u6d17\u814e\u7684\u9839\u52e2\u3002<\/span><\/p>\n

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

\u75c5\u5f9e\u53e3\u5165\u3002\u5728\u5403\u4efb\u4f55\u6771\u897f\u4e4b\u524d\uff0c\u5148\u60f3\u60f3\u662f\u4e0d\u662f\u8981\u5403\u4e0b\u4e86\u6709\u6bd2\u7684\u7269\u8cea\u4e86\u3002\u53e3\u8179\u4e4b\u617e\uff0c\u9700\u8981\u6211\u5011\u53ca\u6642\u61f8\u5d16\u52d2\u99ac\u3002<\/span><\/p>\n

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

\u5728\u9115\u4e0b\u6bd4\u8f03\u5f31\u52e2\u7684\u5730\u65b9\uff0c\u6ab3\u6994\u6524\u5c31\u53ef\u4ee5\u8cb7\u5230\u865f\u7a31\u662f\u300c\u660e\u5929\u7684\u529b\u6c23\u300d\u4e4b\u985e\u7684\u85e5\u9152\uff0c\u9577\u671f\u653e\u4efb\u5982\u6b64\uff0c\u61c9\u8a72\u5c31\u662f\u4e00\u500b\u653f\u5e9c\u653e\u4efb\u4e0d\u7ba1\u7684\u9053\u5fb7\u554f\u984c\u4e86\uff0c\u4e0d\u662f\u55ce\uff1f<\/span><\/p>\n

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

*<\/span>\uff1a\u300a\u5403\u85e5\u524d\uff0c\u4f60\u5fc5\u9808\u77e5\u9053\u7684\u4e8b\u300b\uff0c<\/span> <\/span>\u738b\u60e0\u73c0<\/span> <\/span>\u8457<\/span><\/p>\n

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**<\/span>\uff1a\u3008\u53f0\u7063\u6d17\u814e\u4eba\u53e3\u6bd4\u4f8b\u4e16\u754c\u7b2c\u4e00<\/span> <\/span>\u6bcf\u4eba\u6bcf\u5e74\u8981\u82b1\u8cbb\u5065\u4fdd<\/span>43<\/span>\u842c\u3009\uff0c<\/span>2020\/12\/6 <\/span>\u4e2d\u6642\u65b0\u805e\u7db2<\/span><\/p>\n

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2021\/3\/26 <\/span>\u5403\u85e5\u524d\uff0c\u4f60\u5fc5\u9808\u77e5\u9053\u7684\u4e8b<\/span> Damakey<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

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