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\n

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

10 \u5e74\u65f6\u95f4\uff0c\u82b1\u8d39 10 \u4ebf\u7f8e\u5143\uff0c\u7814\u53d1\u4e00\u6b3e\u65b0\u836f\uff0c\u65e0\u8bba\u662f\u5229\u76ca\u7684\u9a71\u52a8\uff0c\u8fd8\u662f\u62ef\u6551\u4e07\u5343\u60a3\u8005\u7684\u6210\u5c31\u611f\uff0c\u836f\u4f01\u7684\u8fd9\u4e00\u884c\u4e3a\u90fd\u503c\u5f97\u6211\u4eec\u5c0a\u656c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

 \u4e00\u6b3e\u65b0\u836f\u4ece\u7814\u53d1\u5230\u4e0a\u5e02\u90fd\u9700\u8981\u7ecf\u8fc7\u54ea\u4e9b\u6d41\u7a0b\uff1f\u6bcf\u4e00\u6b65\u53c8\u6709\u54ea\u4e9b\u7ecf\u9a8c\u53ef\u4ee5\u501f\u9274\uff1f\u672c\u6587\u4ee5\u5c0f\u5206\u5b50\u836f\u7269\u4e3a\u4f8b\uff0c\u8bd5\u7740\u505a\u4e86\u4e00\u4e2a\u68b3\u7406\uff0c\u5e0c\u671b\u80fd\u5bf9\u60a8\u6709\u6240\u5e2e\u52a9\u3002<\/span><\/p>\n

 <\/span><\/p>\n

1\u3001 <\/span>\u4e34\u5e8a\u524d\u7814\u7a76<\/span><\/span><\/p>\n

 <\/span><\/p>\n

1.\u7814\u7a76\u5f00\u53d1\uff08\u4e00\u822c 2-3\u5e74\uff09<\/span><\/p>\n

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 <\/span><\/p>\n

1\uff09\u836f\u7269\u9776\u70b9\u7684\u53d1\u73b0\u53ca\u786e\u8ba4<\/span><\/strong><\/p>\n

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 <\/span><\/p>\n

2\uff09\u5316\u5408\u7269\u7684\u7b5b\u9009\u4e0e\u5408\u6210<\/span><\/strong><\/p>\n

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 <\/span><\/p>\n

3\uff09\u6d3b\u6027\u5316\u5408\u7269\u7684\u9a8c\u8bc1\u4e0e\u4f18\u5316<\/span><\/strong><\/p>\n

\u4e0d\u662f\u6240\u6709\u5148\u5bfc\u5316\u5408\u7269\u90fd\u80fd\u7b26\u5408\u8981\u6c42\uff0c\u5728\u8fd9\u4e2a\u9636\u6bb5\u9700\u8981\u901a\u8fc7\u4f53\u5916\u7ec6\u80de\u8bd5\u9a8c\u9a8c\u8bc1\uff0c\u521d\u6b65\u7b5b\u9009\u51fa\u6d3b\u6027\u9ad8\u3001\u6bd2\u6027\u4f4e\u7684\u5316\u5408\u7269\uff0c\u5e76\u6839\u636e\u6784\u6548\u5173\u7cfb\u8fdb\u884c\u7ed3\u6784\u4f18\u5316\uff0c\u8fd9\u4e9b\u5316\u5408\u7269\u79f0\u4e3a\u836f\u7269\u5019\u9009\u7269\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u540c\u65f6\u4e5f\u5b58\u5728\u4e00\u4e2a\u5316\u5408\u7269\u5bf9\u76ee\u6807<\/span> A \u9776\u70b9\u6ca1\u6709\u4f5c\u7528\uff0c\u5374\u6709\u53ef\u80fd\u5bf9\u5176\u4ed6\u7684 B \u9776\u70b9\u3001C \u9776\u70b9\u6709\u975e\u5e38\u597d\u6d3b\u6027\u7684\u60c5\u51b5\uff0c\u6682\u4e14\u4e0d\u8868\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2.\u4e34\u5e8a\u524d\u5b9e\u9a8c\uff08\u4e00\u822c 2-4\u5e74\uff09<\/span><\/p>\n

\u8fd9\u4e00\u9636\u6bb5\u76ee\u7684\uff0c\u4e00\u662f\u8bc4\u4f30\u836f\u7269\u7684\u836f\u7406\u548c\u6bd2\u7406\u4f5c\u7528\uff0c\u836f\u7269\u7684\u5438\u6536\u3001\u5206\u5e03\u3001\u4ee3\u8c22\u548c\u6392\u6cc4\u60c5\u51b5\uff08<\/span>ADME\uff09\u3002\u4e8c\u662f\u8fdb\u884c\u751f\u4ea7\u5de5\u827a\u3001\u8d28\u91cf\u63a7\u5236\u3001\u7a33\u5b9a\u6027\u7b49\u7814\u7a76\uff08CMC\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u7b2c\u4e00\u90e8\u5206\u7684\u5b9e\u9a8c\u9700\u8981\u5728\u52a8\u7269\u5c42\u9762\u5c55\u5f00\uff0c\u7ec6\u80de\u5b9e\u9a8c\u7684\u7ed3\u679c\u548c\u6d3b\u4f53\u52a8\u7269\u5b9e\u9a8c\u7684\u7ed3\u679c\u6709\u65f6\u5019\u4f1a\u6709\u5f88\u5927\u7684\u5dee\u5f02\u3002\u8fd9\u4e00\u6b65\u7684\u76ee\u7684\u662f\u786e\u5b9a\u836f\u7269\u7684\u6709\u6548\u6027\u4e0e\u5b89\u5168\u6027\u3002\u7b2c\u4e8c\u90e8\u5206\u9700\u8981\u5728\u7b26\u5408<\/span>GMP\u8981\u6c42\u7684\u8f66\u95f4\u5b8c\u6210\u3002<\/span><\/p>\n

 <\/span><\/p>\n

1\uff09\u836f\u7406\u5b66\u7814\u7a76 <\/span><\/strong><\/p>\n

\u5305\u62ec\uff1a\u836f\u6548\u5b66\u3001\u836f\u52a8\u5b66<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

2\uff09\u6bd2\u7406\u5b66\u7814\u7a76 <\/span><\/strong><\/p>\n

\u6025\u6bd2\u3001\u957f\u6bd2\u3001\u751f\u6b96\u6bd2\u6027\uff0c\u81f4\u764c\u3001\u81f4\u7578\u3001\u81f4\u7a81\u53d8\u60c5\u51b5<\/span><\/span><\/p>\n

 <\/span><\/p>\n

3\uff09\u5236\u5242\u7684\u5f00\u53d1<\/span><\/strong><\/p>\n

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 <\/span><\/p>\n

2\u3001 <\/span> <\/span>\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u6279<\/span> Investigational New Drug\uff08IND\uff09<\/span><\/p>\n

 <\/span><\/p>\n

\"\u3010\u65b0\u836f\u7814\u53d1\u4e0a\u5e02\u3011<\/p>\n

\u56fe<\/span>1<\/span>
<\/p>\n

3\u3001 <\/span>\u4e34\u5e8a\u8bd5\u9a8c\uff08\u4e00\u822c<\/span>3-7\u5e74\uff09<\/span><\/p>\n

 <\/span><\/p>\n

\u4eba\u4f53\u8bd5\u9a8c\u5171\u5206\u4e09\u671f\uff1a<\/span> <\/span><\/p>\n

  \u2022 \u2160\u671f\u4e34\u5e8a 20-100\u4f8b\uff0c\u6b63\u5e38\u4eba\uff0c\u4e3b\u8981\u8fdb\u884c\u5b89\u5168\u6027\u8bc4\u4ef7\u3002 <\/span><\/p>\n

  \u2022 \u2161\u671f\u4e34\u5e8a 100-300\u4f8b\uff0c\u75c5\u4eba\uff0c\u4e3b\u8981\u8fdb\u884c\u6709\u6548\u6027\u8bc4\u4ef7 \u3002<\/span><\/p>\n

  \u2022 \u2162\u671f\u4e34\u5e8a 300-5000\u4f8b\uff0c\u75c5\u4eba\uff0c\u6269\u5927\u6837\u672c\u91cf\uff0c\u8fdb\u4e00\u6b65\u8bc4\u4ef7\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u56e0\u4e3a<\/span> \u2160-\u2162 \u671f\u4e34\u5e8a\u5728\u6574\u4e2a\u836f\u7269\u7814\u53d1\u8fc7\u7a0b\u4e2d\u975e\u5e38\u91cd\u8981\uff0c\u6211\u4eec\u91cd\u70b9\u8bb2\u4e00\u4e0b\u8fd9\u90e8\u5206\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4f20\u7edf\u610f\u4e49\u4e0a\uff0c\u65b0\u836f\u7684\u4e34\u5e8a\u7814\u7a76\u5206\u4e3a<\/span>I\/II\/III\u671f\uff0c\u540e\u6765 II \u671f\u6709\u5206\u6210 IIa \u548c IIb\uff08\u5f88\u5927\u7a0b\u5ea6\u4e0a\u662f\u56e0\u4e3a\u80bf\u7624\u836f\u7269\u7814\u7a76\uff09\uff0c\u63a5\u7740\u51fa\u73b0\u4e86 0 \u671f\u7814\u7a76\u7684\u6982\u5ff5\uff08\u5f88\u5927\u7a0b\u5ea6\u4e0a\u4e5f\u662f\u56e0\u4e3a\u80bf\u7624\u836f\u7269\u7684\u7814\u53d1\uff09\u3002\u7136\u540e\u53c8\u6709\u4eba\u63d0\u51fa\uff0c0\/I \u671f\u4e3a\u65e9\u671f\u4e34\u5e8a\u7814\u7a76\uff0cIIa \u4e3a\u4e2d\u671f\u4e34\u5e8a\u7814\u7a76\uff0cIIb \u548c III \u671f\u4e3a\u665a\u671f\u4e34\u5e8a\u7814\u7a76\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u8fd9\u79cd\u5206\u7c7b\uff0c\u5176\u5b9e\u6211\u89c9\u5f97\u5728\u4e24\u4e2a\u65b9\u9762\u5bf9\u6211\u4eec\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u8bbe\u8ba1\u7684\u4eba\u6765\u8bf4\uff0c\u662f\u5f88\u91cd\u8981\u7684\uff1a<\/span><\/span><\/p>\n

 <\/span><\/p>\n

1. \u5206\u671f\u662f\u548c\u7814\u7a76\u76ee\u7684\u76f8\u5173\u7684\uff0c\u4e0d\u540c\u7684\u76ee\u7684\uff0c\u53ef\u4ee5\u5206\u5230\u4e0d\u540c\u65f6\u671f\/\u9636\u6bb5\u7684\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2. \u4e0d\u540c\u65f6\u671f\/\u9636\u6bb5\u7684\u4e34\u5e8a\u7814\u7a76\uff0c\u5f80\u5f80\u5bf9\u5e94\u4e8e\u4e00\u5b9a\u7684\u7814\u7a76\u6846\u67b6\u8bbe\u8ba1\uff08\u4ea4\u53c9\u7814\u7a76\uff0c\u5e73\u884c\u5bf9\u7167\uff0c\u5355\u81c2\uff0c\u7ec8\u70b9\u9009\u62e9\u7b49\u7b49\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u6240\u4ee5\uff0c\u7406\u89e3\u4e0d\u540c\u65f6\u671f<\/span>\/\u9636\u6bb5\u7684\u4e34\u5e8a\u7814\u7a76\uff0c\u5176\u610f\u4e49\u5df2\u7ecf\u8d85\u51fa\u4e86\u77e5\u9053\u6709\u8fd9\u6837\u7684\u5206\u6cd5\u672c\u8eab\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u5206\u671f\u7684\u4e00\u5934\u662f\u7814\u7a76\u76ee\u7684\uff0c\u53e6\u4e00\u5934\u662f\u5bf9\u5e94\u7684\u8bbe\u8ba1\u6846\u67b6\uff08\u5f53\u7136\u4e5f\u53ea\u662f\u7c97\u7565\u7684\u6846\u67b6\uff0c\u5f88\u591a\u95ee\u9898\uff0c\u8981\u6839\u636e\u75be\u75c5\u3001\u836f\u7269\u7b49\u6765\u786e\u5b9a\uff09\uff0c\u7406\u89e3\u5206\u671f\uff0c\u6709\u52a9\u4e8e\u6211\u4eec\u4e86\u89e3\uff0c\u4e00\u4e2a\u7814\u7a76\u76ee\u7684\uff0c\u5927\u4f53\u4e0a\u6709\u54ea\u4e9b\u8bbe\u8ba1\u65b9\u6cd5\u548c\u601d\u8def\uff0c\u5927\u4f53\u4e0a\u53ef\u4ee5\u5982\u4f55\u53bb\u5904\u7406\uff1b\u4e3a\u4ec0\u4e48\u8be5\u5982\u6b64\u8fdb\u884c\uff0c\u5404\u79cd\u8bbe\u8ba1\u7684\u4f18\u7f3a\u70b9\u5728\u54ea\u91cc\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u6240\u4ee5\uff0c\u6211\u4eec\u5148\u770b\u4e00\u4e0b\u4e0d\u540c\u9636\u6bb5\u7684\u7814\u7a76\u76ee\u7684\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

1. <\/span>0 \u671f<\/span><\/strong><\/p>\n

\u76ee\u7684\u662f\u5728\u6ee1\u8db3\u4e00\u5b9a\u7684\u7edf\u8ba1\u5b66\u8981\u6c42\u7684\u524d\u63d0\u4e0b\uff0c\u5728\u6709\u9650\u7684\u6837\u672c\u91cf\uff08\u901a\u5e38\u4e0d\u8d85\u8fc7<\/span>20\uff09\u3001\u6709\u9650\u7684\u65f6\u95f4\u5185\uff08\u6bcf\u4e2a\u60a3\u8005\u7684\u6cbb\u7597\u671f\u5e38\u4e0d\u8d85\u8fc7\u6570\u5468\uff09\uff0c\u521d\u6b65\u5224\u65ad\u4e00\u4e2a\u7814\u7a76\u836f\u7269\u662f\u5426\u6709\u6548\u3001\u67d0\u4e2a\u5242\u91cf\u662f\u5426\u6709\u6548\uff0c\u662f\u5426\u5e94\u7ee7\u7eed\u5f00\u53d1\u4e0b\u53bb\uff0c\u9644\u5e26\u770b\u4e00\u4e0b\u67d0\u4e9b\u7597\u6548\u5224\u65ad\u65b9\u6cd5\u662f\u5426\u53ef\u884c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4ece\u76ee\u7684\u89d2\u5ea6\uff0c<\/span>0 \u671f\u7814\u7a76\u4e5f\u662f\u521d\u6b65\u5224\u65ad\u836f\u7269\u7684\u6548\u679c\uff0c\u7c7b\u4f3c II \u671f\uff08\u5c24\u5176\u662fIIa\uff09\uff0c\u6240\u4ee5 0 \u671f\u7684\u8bbe\u8ba1\uff0c\u5728\u67d0\u4e9b\u65b9\u9762\u7c7b\u4f3c IIa \u7684\u5355\u81c2\u7814\u7a76\uff0c\u4f46\u662f\u7531\u4e8e\u6837\u672c\u91cf\u5c0f\u3001\u53c8\u8981\u6ee1\u8db3\u4e00\u5b9a\u7684\u7edf\u8ba1\u5b66\u8981\u6c42\uff0c\u6240\u4ee5\u4e5f\u6709\u5176\u7279\u70b9\uff0c\u8bbe\u8ba1\u8d77\u6765\u5176\u5b9e\u53ef\u80fd\u66f4\u4e3a\u590d\u6742\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2. <\/span>I \u671f<\/span><\/strong><\/p>\n

\u901a\u5e38\u662f\u6478\u7d22\u5242\u91cf\uff08<\/span>dose finding, dose-ranging\uff09\uff0c\u836f\u4ee3\uff08PK\uff09\u548c\u836f\u52a8\uff08PD\uff09\uff0c\u6837\u672c\u91cf\u4e5f\u4e0d\u5927\uff08\u4e00\u822c\u4e0d\u8d85\u8fc720\uff0c\u6216\u800520\u5de6\u53f3\uff09\u3002\u5c24\u5176\u662fPD\uff0c\u901a\u5e38\u4f1a\u4f7f\u7528\u4ea4\u53c9\u7814\u7a76\uff0c\u56e0\u4e3a\u4ea4\u53c9\u7814\u7a76\u6709\u5176\u7279\u70b9\uff0c\u9002\u5408\u6b64\u7c7b\u8bbe\u8ba1\u76ee\u7684\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4ea4\u53c9\u7814\u7a76\u4e2d\uff0c\u6bcf\u4e2a\u60a3\u8005\u90fd\u662f\u5176\u81ea\u5df1\u7684\u5bf9\u7167\uff08\u5728\u4e0d\u540c\u9636\u6bb5\uff0c\u5206\u522b\u626e\u6f14\u7814\u7a76\u7ec4\u548c\u5bf9\u7167\u7ec4\u7684\u89d2\u8272\uff09\uff0c\u800c\u4e14\u4ea4\u53c9\u7814\u7a76\u7684\u53d8\u91cf\u4e00\u822c\u5c0f\u4e8e\u5e73\u884c\u5bf9\u7167\uff0c\u6240\u4ee5\u5728\u5229\u7528\u6837\u672c\u65b9\u9762\uff0c\u4ea4\u53c9\u7814\u7a76\u7684\u6548\u7387\u8fdc\u9ad8\u4e8e\u5e73\u884c\u5bf9\u7167\uff0c\u4ea4\u53c9\u7814\u7a76\u5982\u679c\u7eb3\u5165<\/span> 20 \u4f8b\u60a3\u8005\uff0c\u5e73\u884c\u5bf9\u7167 50 \u4f8b\u90fd\u4e0d\u4e00\u5b9a\u80fd\u83b7\u5f97\u76f8\u4f3c\u7684\u7ed3\u679c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4f46\u662f\u4ea4\u53c9\u5bf9\u7167\u4e5f\u6709\u5f88\u591a\u9650\u5236\uff0c\u4f8b\u5982\u8131\u843d\u548c\u5931\u8bbf\u5bf9\u4ea4\u53c9\u7814\u7a76\u7684\u5f71\u54cd\u8fdc\u5927\u4e8e\u5e73\u884c\u5bf9\u7167\u7814\u7a76\uff1b\u540c\u4e00\u4e2a\u4eba\uff0c\u4e0d\u540c\u65f6\u671f\u63a5\u53d7\u4e0d\u540c\u6cbb\u7597\u3001\u4e2d\u95f4\u9694\u4ee5\u6d17\u8131\u671f\uff0c\u5bfc\u81f4\u540e\u9057\u6548\u5e94\uff0c\u4ee5\u53ca\u6cbb\u7597<\/span>-\u65f6\u95f4\u76f8\u4e92\u4f5c\u7528\u7b49\u7b49\u3002\u6240\u4ee5\u5728\u540e\u671f\u4e34\u5e8a\u7814\u53d1\u4e2d\uff0c\u5f88\u5c11\u770b\u5230\u6709\u7528\u4ea4\u53c9\u5bf9\u7167\u7684\uff08\u6709\uff0c\u4f46\u8fdc\u5c11\u4e8e\u5e73\u884c\u5bf9\u7167\uff09\u3002<\/span><\/p>\n

 <\/span><\/p>\n

3. <\/span>II \u671f<\/span><\/strong><\/p>\n

II \u671f\u662f\u521d\u6b65\u5224\u65ad\u7597\u6548\u7684\u548c\u5b89\u5168\u6027\u7684\uff08\u5176\u5b9e\u5b89\u5168\u6027\u8d2f\u7a7f\u7814\u53d1\u59cb\u7ec8\uff09\uff0c\u6240\u4ee5\u4e00\u822c\u79f0\u4e3asafety & activity\u7814\u7a76\uff08SA\u7814\u7a76\uff09\u3002\u6709\u591a\u79cd\u505a\u6cd5\uff0c\u6839\u636e\u4e0d\u540c\u7684\u4e34\u5e8a\u75be\u75c5\u73af\u5883\uff0c\u4ee5\u53ca\u65e2\u5f80\u6570\u636e\u7b49\uff0c\u53ef\u4ee5\u91c7\u53d6\u5355\u81c2\uff0c\u5e73\u884c\u5bf9\u7167\u7684 RCT \u7b49\uff0c\u7ec8\u70b9\u4e00\u822c\u9009\u62e9 surrogate\uff0c\u800c\u4e0d\u662f clinical outcome\u3002\u5982\u679c\u5206 IIa \u548c IIb\uff0c\u5219 IIa \u5f80\u5f80\u662f\u5355\u81c2\uff0c\u6837\u672c\u91cf\u4e00\u822c\u4e0d\u4f1a\u8fc7\u767e\uff1bIIb \u5219\u5f80\u5f80\u662f\u5e73\u884c RCT\u3002<\/span><\/p>\n

 <\/span><\/p>\n

4. <\/span>III \u671f<\/span><\/strong><\/p>\n

III \u671f\u662f\u4e25\u683c\u7684\u9a8c\u8bc1\u836f\u7269\u6548\u679c\u7684\u9a8c\u8bc1\u6027\u4e34\u5e8a\u7814\u7a76\u3002\u5f88\u591a\u4f1a\u8bae\u4e0a\u4ecb\u7ecd\u4e34\u5e8a\u7814\u7a76\uff0c\u5f80\u5f80\u4ee5\u6b64\u7c7b\u7814\u7a76\u4e3a\u6a21\u7248\u8fdb\u884c\u4ecb\u7ecd\uff0c\u5728\u5047\u8bbe\u68c0\u9a8c\u7684\u6846\u67b6\u4e0b<\/span><\/p>\n

 <\/span><\/strong><\/p>\n

\u8fdb\u884c\u4ecb\u7ecd\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

4\u3001 <\/span> <\/span>\u65b0\u836f\u4e0a\u5e02\u5ba1\u6279<\/span> New DrugApplication<\/span><\/p>\n

 <\/span><\/p>\n

\u25cf<\/span> <\/span>NDA\u7533\u62a5\u8d44\u6599 \u2014 CTD(CommonTechnical Document)<\/span><\/p>\n

 <\/span><\/p>\n

CTD\u4e3b\u8981\u7531\u4e94\u5927\u6a21\u5757\u7ec4\u6210\uff1a<\/span>
<\/span>\u2460\u884c\u653f\u548c\u6cd5\u89c4\u4fe1\u606f<\/span>
<\/span>\u2461\u6982\u8ff0:\u836f\u7269\u8d28\u91cf\u3001\u975e\u4e34\u5e8a\u3001\u4e34\u5e8a\u8bd5\u9a8c\u7684\u9ad8\u5ea6\u6982\u62ec<\/span>
<\/span>\u2462\u836f\u54c1\u8d28\u91cf\u8be6\u8ff0<\/span>
<\/span>\u2463\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/span>
<\/span>\u2464\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/span><\/p>\n

 <\/span><\/p>\n

\u6d41\u7a0b\uff1a<\/span><\/span><\/p>\n

\"\u3010\u65b0\u836f\u7814\u53d1\u4e0a\u5e02\u3011<\/p>\n

\u56fe<\/span>2<\/span>
<\/p>\n

\u2460\u6279\u51c6\u4fe1<\/span><\/strong><\/p>\n

\u7b26\u5408\u8981\u6c42\uff0c\u53ef\u4ee5\u4e0a\u5e02<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

\u2461\u53ef\u6279\u51c6\u4fe1<\/span><\/strong>
<\/span>\u57fa\u672c\u6ee1\u8db3\u8981\u6c42\uff0c\u5c11\u6570\u4e0d\u8db3\u53ef\u4ee5\u4fee\u6539<\/span> \u3002<\/span><\/span><\/p>\n


<\/span>\u7533\u8bf7\u4eba\u5e94\u5728\u6536\u5230<\/span>10\u65e5\u5185\u4f5c\u51fa\u56de\u5e94\u4fee\u6b63\uff0c\u5426\u5219\u89c6\u4e3a\u81ea\u52a8\u64a4\u56de\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u2462\u62d2\u7edd\u4fe1<\/span><\/strong>
<\/span>\u5b58\u5728\u4e25\u91cd\u95ee\u9898\u6216\u9700\u8981\u8865\u5145\u5927\u91cf\u4fe1\u606f\u8d44\u6599\u3002<\/span> <\/span><\/p>\n


<\/span>\u7533\u8bf7\u4eba\u53ef\u5728<\/span>10\u65e5\u5185\u63d0\u51fa\u4fee\u6b63\u6216\u572830\u65e5\u5185\u8981\u6c42\u542c\u8bc1 \u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u25cf<\/span> <\/span>NDA\u7279\u6b8a\u5ba1\u8bc4\u7a0b\u5e8f <\/span><\/p>\n

 <\/span><\/p>\n

\u2460\u4f18\u5148\u5ba1\u8bc4\uff08PriorityReviews\uff09<\/span><\/strong>
<\/span>\u9002\u7528\u4e8e\u80fd\u591f\u5728\u6cbb\u7597\u3001\u8bca\u65ad\u6216\u9884\u9632\u75be\u75c5\u4e0a\u6bd4\u5df2\u4e0a\u5e02\u836f\u54c1\u6709\u663e\u8457\u6539\u8fdb\u7684\u836f\u54c1\uff0c\u4f18\u5148\u5b89\u6392<\/span>NDA\u5ba1\u8bc4\u3002 <\/span><\/p>\n

 <\/span><\/p>\n

\u2461\u52a0\u901f\u5ba1\u6279\uff08Accelerated Approval\uff09<\/span><\/strong>
<\/span>\u7528\u4e8e\u6cbb\u7597\u4e25\u91cd\u6216\u5371\u53ca\u751f\u547d\u75be\u75c5\u7684\u836f\u54c1\uff0c\u4e14\u5b58\u5728\u5408\u7406\u5e76\u80fd\u591f\u6d4b\u91cf\u7684<\/span>\u201c\u66ff\u4ee3\u7ec8\u70b9\u201d\uff08Surrogate endpoint\uff09\uff0c\u5373\u836f\u7269\u9884\u671f\u7684\u6cbb\u7597\u6548\u679c\u7684\u6307\u6807\uff0c\u53d8\u901a\u5ba1\u8bc4\u6807\u51c6\uff0c\u5229\u7528\u201c\u66ff\u4ee3\u7ec8\u70b9\u201d\u5ba1\u8bc4\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u2462\u5feb\u901f\u901a\u9053\uff08Fast-track\uff09<\/span><\/strong>
<\/span>\u7528\u4e8e\u6cbb\u7597\u4e25\u91cd\u6216\u5371\u53ca\u751f\u547d\u75be\u75c5\u7684\u836f\u54c1\uff0c\u4e14\u6709\u6f5c\u529b\u6ee1\u8db3\u4e34\u5e8a\u5c1a\u672a\u6ee1\u8db3\u7684\u533b\u5b66\u9700\u6c42\uff0c\u65e9\u671f\u4ecb\u5165\uff0c\u5bc6\u5207\u4ea4\u6d41\uff0c\u5206\u9636\u6bb5\u63d0\u4ea4\u7533\u62a5\u8d44\u6599\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u4ee5\u4e07\u7edc\u4e3a\u4f8b\uff0c<\/span> 1998 \u5e74 11 \u6708 23 \u65e5\u4e07\u7edc\u63d0\u4ea4 NDA \u7533\u8bf7\uff0c\u7f16\u53f7 21-042\uff0c\u201c1999 \u5e74 5 \u6708 20 \u65e5\u83b7 FDA \u6279\u51c6\uff0c\u5386\u65f6 178 \u5929\u3002<\/span><\/p>\n

 <\/span><\/p>\n

5\u3001 <\/span>\u4e0a\u5e02\u540e\u7814\u7a76<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

\u4e34\u5e8a\u76d1\u6d4b\u671f\uff1a<\/span>IV\u671f\u4e34\u5e8a <\/span><\/strong><\/p>\n

 <\/span><\/p>\n

\u53d7\u8bd5\u8005\u8981\u5927\u4e8e<\/span> 2000 \u4f8b\uff0c\u540c\u65f6\u8981\u8fdb\u884c\u793e\u4f1a\u6027\u8003\u5bdf\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4ecd\u4ee5\u4e07\u7edc\u4e3a\u4f8b\uff1a<\/span>2000 \u5e74\u8fdb\u884c\u4e86\u201cVIGOR\u201d\u80c3\u80a0\u9053\u8bd5\u9a8c \u2014\u2014\u663e\u793a\u8f83\u5c11\u7684\u80c3\u80a0\u9053\u526f\u4f5c\u7528\uff0c \u4f46\u662f\u4f7f\u7528 18 \u4e2a\u6708\u540e\u4f1a\u5f15\u53d1 2 \u500d\u7684\u5fc3\u810f\u75c5\/\u4e2d\u98ce\u98ce\u9669\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2001 \u5e74\uff0c\u201cAPPROVe\u201d\u817a\u7624\u606f\u8089\u9884\u9632\u8bd5\u9a8c \u2014\u2014\u670d\u836f\u8d85\u8fc7 18 \u4e2a\u6708\u51fa\u73b0\u8f83\u9ad8\u7684\u5fc3\u8840\u7ba1\u75be\u75c5\u98ce\u9669\u3002<\/span><\/p>\n

 <\/span><\/p>\n

6\u3001 <\/span>\u4e0a\u5e02\u540e\u518d\u5ba1\u6279\uff08\u4e00\u822c\u4e0a\u5e02\u540e<\/span>4-10\u5e74\uff09<\/span><\/p>\n

 <\/span><\/p>\n

\u76ee\u7684\uff1a\u91cd\u65b0\u5ba1\u6838<\/span> NDA \u4e2d\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e07\u7edc\uff0c<\/span>2002 \u5e74 4 \u6708\uff1a\u9ed8\u514b\u516c\u53f8\u589e\u52a0\u4e86\u4e07\u7edc\u53ef\u80fd\u51fa\u73b0\u5fc3\u8840\u7ba1\u526f\u4f5c\u7528<\/span><\/p>\n

\u7684\u8b66\u544a\u3002<\/span> <\/span><\/p>\n

 <\/span><\/p>\n

2004 \u5e74 9 \u6708 28 \u65e5\uff0c\u9ed8\u514b\u516c\u53f8\u4e0e FDA \u5546\u8ba8\u6709\u5173\u4e07\u7edc\u5b9e\u9a8c\u7ed3\u679c\u7684\u4e8b\u5b9c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2004 \u5e74 9 \u6708 30 \u65e5\uff0c \u518d\u5ba1\u8bc4\uff1a\u201c\u4e07\u7edc\u201d\uff0c\u7531\u9ed8\u514b\u516c\u53f8\u4e3b\u52a8\u53ec\u56de\u3002<\/span><\/p>\n


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

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

\n
\n
\n

\u8fd1\u671f\u57f9\u8bad<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

\n
\n
\n
\n
\u8fd1\u70ed\u95e8\u57f9\u8bad\u8bfe\u7a0b<\/strong><\/span>\u671f<\/strong>\u8bf7\u70b9\u51fb\u4e0b\u9762<\/strong><\/span>\u84dd\u8272\u8bfe<\/strong><\/span>\u539f<\/strong>\u9898\u94fe\u63a5<\/strong><\/span>\u9605\u8bfb<\/strong>\u6587<\/strong><\/p>

<\/strong><\/p>
<\/strong><\/p>
\u5317\u4eac\u5e026\u670828-30\u53f7<\/span>-\u7ed3\u6676\u5de5\u827a\u5f00\u53d1\u7814\u7a76\u548c\u8bbe\u8ba1\u57f9\u8bad\u73ed

<\/span><\/a><\/strong><\/span><\/p>
\u5317\u4eac7<\/span>\u6708<\/span>26-28<\/span>\u65e5<\/span>-<\/span>\u836f\u7269\u6742\u8d28\u7814\u7a76\u8981\u70b9\u89e3\u6790\u4e0e\u6848\u4f8b\u5206\u6790\u9ad8\u7ea7\u7814\u4fee\u73ed<\/span><\/span><\/strong><\/span><\/a><\/p>

<\/span><\/a>\u4e0a\u6d77\u5e026<\/span>\u6708<\/span>19-21<\/span>\u65e5<\/span><\/span>-FDA483 \u4e0e\u6b27\u7f8e<\/span>CGMP\u73b0\u573a\u5ba1\u8ba1\u89e3\u6790\u4e0e\u6848\u4f8b
\u5206\u6790\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a><\/strong><\/span>
<\/p>

<\/span><\/p>
<\/span><\/p>
\u4e0a\u6d77\u5e026\u670822-24\u53f7<\/span>-\u836f\u54c1\u4e13\u5229\u4fdd\u62a4\u548c\u4e13\u5229\u5e03\u5c40\u5b9e\u6218\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5

<\/span><\/strong><\/a><\/p>
\u4e0a\u6d77-<\/span>7<\/span>\u6708<\/span>23-25<\/span>\u65e5<\/span>\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279\u89e3\u6790\u53ca\u5982\u4f55\u7f16\u5199\u7533\u62a5\u8d44\u6599\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/strong><\/span><\/a><\/p>
<\/span><\/strong><\/a>
<\/p>
<\/span>
<\/p>
\u5357\u4eac\u5e026<\/span>\u670828-30<\/span><\/span>-\u65e0\u83cc\u751f\u4ea7\u5982\u4f55\u901a\u8fc7\u56fd\u5185\u5916<\/span>cGMP\u8ba4\u8bc1\u201d\u4e13\u9898\u57f9\u8bad\u73ed<\/span><\/strong><\/a><\/p>

<\/p>
\uff086\u670813-15\u5317\u4eac\uff092018 QA\u4e13\u5458\u6280\u80fd\u5b8c\u5584\u3001\u63d0\u5347\u4e0e\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5

<\/span><\/a><\/strong><\/span><\/p>
\u676d\u5dde\u5e022018\u5e746\u670822-24\u65e5<\/span><\/span>-\u836f\u54c1\u5236\u5907\u5de5\u827a\u5f00\u53d1\u4e0e\u5de5\u827a\u9a8c\u8bc1<\/span>\/\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7814\u7a76\u4e0e\u5b9e\u65bd\u201d\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a><\/p>

<\/p>

<\/p>
\u5357\u4eac\u5e026<\/span>\u6708<\/span>21<\/span>\u65e5\u81f3<\/span>23<\/span>\u65e5<\/span><\/strong><\/span>-\u57fa\u4e8e<\/span>GxP\u539f\u5219\u7684\u836f\u5382\u57f9\u8bad\u4f53\u7cfb\u5efa\u7acb<\/span><\/a><\/span><\/strong><\/span><\/p>
\u3001<\/span><\/a><\/span><\/strong><\/span><\/p>
\u5b9e\u65bd\u4e0e\u5b8c\u5584\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5


<\/a><\/span><\/strong><\/span><\/p>
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<\/p>

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<\/p><\/pre>\n<\/section>\n

<\/p>\n
\u62a5\u540d\u54a8\u8be2  \u5c1a\u4e3915652565785\uff08\u5fae\u4fe1\u540c\u53f7<\/strong><\/strong>\uff09<\/strong><\/strong><\/p>\n
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\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

<\/p>\n
\n
\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                         \u836f\u4f01\u6280\u672f\u4ea4\u6d41\u8054\u76df                      <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
10 \u5e74\u65f6\u95f4\uff0c\u82b1\u8d39 10 \u4ebf\u7f8e\u5143\uff0c\u7814\u53d1\u4e00\u6b3e\u65b0\u836f\uff0c\u65e0\u8bba\u662f\u5229\u76ca\u7684\u9a71\u52a8\uff0c\u8fd8\u662f\u62ef\u6551\u4e07\u5343\u60a3\u8005\u7684\u6210\u5c31\u611f\uff0c\u836f\u4f01\u7684\u8fd9\u4e00\u884c\u4e3a\u90fd\u503c […]<\/p>\n","protected":false},"author":1,"featured_media":9952,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9951"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=9951"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9951\/revisions"}],"predecessor-version":[{"id":9956,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9951\/revisions\/9956"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/9952"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=9951"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=9951"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=9951"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}