{"id":4123,"date":"2021-09-21T15:51:47","date_gmt":"2021-09-21T15:51:47","guid":{"rendered":"https:\/\/curesz.org\/?page_id=4123"},"modified":"2023-01-27T00:23:46","modified_gmt":"2023-01-27T00:23:46","slug":"the-intricate-journey-of-bringing-new-medicines-to-patients","status":"publish","type":"page","link":"https:\/\/curesz.org\/zh\/the-intricate-journey-of-bringing-new-medicines-to-patients\/","title":{"rendered":"\u4e3a\u60a3\u8005\u5e26\u6765\u65b0\u836f\u7684\u9519\u7efc\u590d\u6742\u7684\u65c5\u7a0b"},"content":{"rendered":"

<\/span><\/div>

Karuna Therapeutics \u9996\u5e2d\u533b\u7597\u5b98 Stephen Brannan \u535a\u58eb<\/strong><\/p>\n<\/div><\/div><\/div>

\u6df1\u5165\u4e86\u89e3\u4e3a\u7f8e\u56fd\u60a3\u8005\u63d0\u4f9b\u65b0\u578b\u7cbe\u795e\u79d1\u836f\u7269\u7684\u590d\u6742\u8fc7\u7a0b<\/strong>\u00a0<\/em><\/p>\n

\u5927\u8111\u662f\u4eba\u4f53\u4e2d\u6700\u590d\u6742\u7684\u5668\u5b98\u4e4b\u4e00\u2014\u2014\u4f46\u5b83\u7a76\u7adf\u662f\u5982\u4f55\u5de5\u4f5c\u7684\u5728\u5f88\u5927\u7a0b\u5ea6\u4e0a\u4ecd\u662f\u672a\u77e5\u6570\u3002\u6211\u5f88\u65e9\u5c31\u77e5\u9053\u6211\u60f3\u66f4\u597d\u5730\u4e86\u89e3\u5927\u8111\u7684\u5de5\u4f5c\u539f\u7406\uff0c\u4ee5\u53ca\u5b83\u5728\u6211\u4eec\u601d\u8003\u3001\u611f\u53d7\u548c\u884c\u4e3a\u65b9\u5f0f\u4e2d\u7684\u4f5c\u7528\u3002\u5f53\u6211\u6210\u4e3a\u4e00\u540d\u7cbe\u795e\u79d1\u533b\u751f\u65f6\uff0c\u6211\u610f\u8bc6\u5230\u6709\u6548\u7684\u836f\u7269\u548c\u6cbb\u7597\u8ba1\u5212\u53ef\u4ee5\u663e\u7740\u6539\u5584\u60a3\u8005\u7684\u751f\u6d3b\u8d28\u91cf\u3002<\/p>\n

\u81ea\u4ece\u8fdb\u5165\u5236\u836f\u884c\u4e1a\u4ee5\u6765\uff0c\u6211\u79ef\u6781\u53c2\u4e0e\u4e86\u5305\u62ec\u7cbe\u795e\u5206\u88c2\u75c7\u5728\u5185\u7684\u5404\u79cd\u75be\u75c5\u7684\u65b0\u836f\u7814\u53d1\u5de5\u4f5c\u3002\u4f46\u662f\uff0c\u4e3a\u60a3\u6709\u7cbe\u795e\u75be\u75c5\u7684\u4eba\u5f00\u53d1\u65b0\u836f\u7a76\u7adf\u9700\u8981\u4ec0\u4e48\uff1f<\/p>\n

\u5f00\u53d1\u65b0\u836f\u7684\u8fc7\u7a0b\u9700\u8981\u5927\u91cf\u7684\u65f6\u95f4\u548c\u8d44\u6e90\uff0c\u6700\u91cd\u8981\u7684\u662f\uff0c\u9700\u8981\u5bf9\u6709\u9700\u8981\u7684\u4eba\u505a\u51fa\u575a\u5b9a\u7684\u627f\u8bfa\u3002\u4e00\u79cd\u65b0\u836f\u4ece\u53d1\u73b0\u3001\u5f00\u53d1\u5230\u6700\u7ec8\u5230\u8fbe\u60a3\u8005\u624b\u4e2d\u5e73\u5747\u9700\u898110\u5e74\u65f6\u95f4\u30021<\/sup>\u00a0\u8fd9\u4e00\u5f00\u53d1\u8fc7\u7a0b\u7531\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u76d1\u7763\uff0c\u4ee5\u786e\u4fdd\u836f\u7269\u65e2\u6709\u6548\u53c8\u5b89\u5168\u3002<\/p>\n

\u5728\u7cbe\u795e\u75c5\u5b66\u4e2d\uff0c\u8981\u627e\u5230\u4e00\u79cd\u5bf9\u5927\u591a\u6570\u60c5\u51b5\u4e0b\u4f34\u968f\u7684\u4e00\u7cfb\u5217\u75c7\u72b6\u6709\u6548\u7684\u6cbb\u7597\u65b9\u6cd5\u5c24\u5176\u5177\u6709\u6311\u6218\u6027\u3002\u5b83\u5177\u6709\u6311\u6218\u6027\u7684\u4e00\u4e2a\u539f\u56e0\u662f\u7f3a\u4e4f\u4f17\u6240\u5468\u77e5\u7684\u751f\u7269\u6807\u5fd7\u7269\uff0c\u8fd9\u4e9b\u751f\u7269\u6807\u5fd7\u7269\u662f\u75be\u75c5\u6216\u75c5\u75c7\u5b58\u5728\u6216\u4e25\u91cd\u7a0b\u5ea6\u7684\u53ef\u6d4b\u91cf\u6307\u6807\u3002\u5fc3\u7387\u548c\u8840\u538b\u7b49\u751f\u7269\u6807\u5fd7\u7269\u53ef\u4ee5\u5e2e\u52a9\u786e\u5b9a\u8eab\u4f53\u7cfb\u7edf\u662f\u5426\u6b63\u5e38\u5de5\u4f5c\uff0c\u56e0\u6b64\u5bf9\u75be\u75c5\u7684\u8bca\u65ad\u548c\u6cbb\u7597\u975e\u5e38\u6709\u5e2e\u52a9\u3002\u5c3d\u7ba1\u6211\u4eec\u5728\u7cbe\u795e\u75c5\u5b66\u65b9\u9762\u7f3a\u4e4f\u6210\u719f\u7684\u751f\u7269\u6807\u5fd7\u7269\uff0c\u4f46\u6211\u4eec\u5f00\u53d1\u4e86\u5176\u4ed6\u5de5\u5177\u6765\u5e2e\u52a9\u6211\u4eec\u4e86\u89e3\u75be\u75c5\u7684\u5b58\u5728\u548c\u4e25\u91cd\u7a0b\u5ea6\u3002\u4f8b\u5982\uff0c\u533b\u751f\u4f7f\u7528\u9633\u6027\u548c\u9634\u6027\u7efc\u5408\u75c7\u91cf\u8868 (PANSS)\uff0c\u8fd9\u662f\u4e00\u79cd\u7531\u4e00\u7cfb\u5217\u6807\u51c6\u5316\u95ee\u9898\u7ec4\u6210\u7684\u533b\u5b66\u91cf\u8868\uff0c\u7528\u4e8e\u4e86\u89e3\u7cbe\u795e\u5206\u88c2\u75c7\u60a3\u8005\u53ef\u80fd\u51fa\u73b0\u7684\u75c7\u72b6\u7684\u4e25\u91cd\u7a0b\u5ea6\u30022 <\/sup> \u8be5\u91cf\u8868\u8fd8\u7528\u4f5c\u8ddf\u8e2a\u836f\u7269\u662f\u5426\u6709\u52a9\u4e8e\u51cf\u8f7b\u75c7\u72b6\u7684\u57fa\u51c6\u3002\u4f9d\u8d56\u8bf8\u5982\u6b64\u7c7b\u7684\u8bca\u65ad\u5de5\u5177\u53ea\u662f\u7cbe\u795e\u75c5\u5b66\u4e0e\u5176\u4ed6\u533b\u5b66\u9886\u57df\u622a\u7136\u4e0d\u540c\u7684\u4e00\u79cd\u65b9\u5f0f\u3002<\/p>\n

\u7f8e\u56fd\u7684\u7cbe\u795e\u75c5\u836f\u7269\u5f00\u53d1\u6d89\u53ca\u5168\u9762\u6d4b\u8bd5\uff0c\u4ee5\u786e\u4fdd\u836f\u7269\u5728\u63d0\u4f9b\u7ed9\u60a3\u8005\u4e4b\u524d\u662f\u5b89\u5168\u6709\u6548\u7684\uff0c\u901a\u5e38\u9075\u5faa\u4e94\u4e2a\u6b65\u9aa4\u30023<\/sup><\/p>\n

1.\u836f\u7269\u53d1\u73b0\uff1a<\/strong> \u836f\u7269\u53d1\u73b0\u662f\u786e\u5b9a\u6f5c\u5728\u65b0\u7597\u6cd5\u7684\u8fc7\u7a0b\u3002\u5728\u8fd9\u91cc\uff0c\u5bf9\u6570\u4ee5\u5343\u8ba1\u7684\u5316\u5408\u7269\u8fdb\u884c\u4e86\u8fdb\u4e00\u6b65\u5f00\u53d1\u7684\u8bc4\u4f30\u2014\u2014\u7136\u800c\uff0c\u53ea\u6709\u5c11\u6570\u5316\u5408\u7269\u663e\u793a\u51fa\u4e86\u5e0c\u671b\u3002<\/p>\n

2. \u4e34\u5e8a\u524d\u7814\u7a76\uff1a<\/strong> \u4e00\u65e6\u786e\u5b9a\u4e86\u4e00\u79cd\u5316\u5408\u7269\uff0c\u5b83\u5c06\u8fdb\u5165\u201c\u4e34\u5e8a\u524d\u7814\u7a76\u201d\uff0c\u5728\u52a8\u7269\u8eab\u4e0a\u8fdb\u884c\u8fdb\u4e00\u6b65\u7684\u6d4b\u8bd5\u3002\u8fd9\u662f\u4e3a\u4e86\u5728\u5bf9\u4eba\u4f53\u8fdb\u884c\u7814\u7a76\u4e4b\u524d\u786e\u8ba4\u5b83\u7b26\u5408\u57fa\u672c\u7684\u5b89\u5168\u8981\u6c42\u3002\u636e\u4f30\u8ba1\uff0c\u5728\u4e34\u5e8a\u524d\u7814\u7a76\u4e2d\u7814\u7a76\u7684\u7565\u4f4e\u4e8e 10% \u7684\u5316\u5408\u7269\u5c06\u8fdb\u5165\u4e34\u5e8a\u7814\u7a76\u30024<\/sup><\/p>\n

\u4e34\u5e8a\u524d\u7814\u7a76\u5728\u7cbe\u795e\u75c5\u5b66\u4e2d\u5c24\u5176\u5177\u6709\u6311\u6218\u6027\uff0c\u56e0\u4e3a\u52a8\u7269\u8bd5\u9a8c\u5e76\u4e0d\u603b\u80fd\u63d0\u4f9b\u53ef\u9760\u7684\u4eba\u7c7b\u6709\u6548\u6027\u6307\u6807\u3002\u00a0<\/strong><\/p>\n

3. \u4e34\u5e8a\u7814\u7a76\uff1a<\/strong> \u4e34\u5e8a\u7814\u7a76\u6d89\u53ca\u5bf9\u4eba\u7c7b\u5fd7\u613f\u8005\u7684\u7814\u7a76\u3002\u4e34\u5e8a\u7814\u7a76\u6709\u4e0d\u540c\u7684\u9636\u6bb5\uff0c\u5176\u89c4\u6a21\u548c\u76ee\u7684\u5404\u4e0d\u76f8\u540c\uff0c\u4ee5\u786e\u4fdd\u836f\u7269\u5b89\u5168\u6709\u6548\u3002<\/p>\n

\u7b2c\u4e00\u9636\u6bb5\u7814\u7a76\u662f\u7814\u7a76\u7684\u7b2c\u4e00\u9636\u6bb5\u3002\u8fd9\u4e9b\u7814\u7a76\u5bfb\u6c42\u6709\u5173\u6f5c\u5728\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u9002\u5f53\u5242\u91cf\u7684\u4fe1\u606f\uff0c\u901a\u5e38\u5728 20 \u5230 100 \u4eba\u4e2d\u8fdb\u884c\uff0c\u4ee5\u786e\u4fdd\u5728\u7814\u7a76\u66f4\u5927\u7684\u4eba\u7fa4\u4e4b\u524d\u836f\u7269\u662f\u5b89\u5168\u7684\u3002<\/p>\n

2 \u671f\u7814\u7a76\u901a\u5e38\u5305\u62ec\u6570\u767e\u540d\u60a3\u6709\u6b63\u5728\u7814\u7a76\u7684\u75be\u75c5\u6216\u75c5\u75c7\u7684\u4eba\u3002\u8fd9\u4e9b\u7814\u7a76\u7684\u91cd\u70b9\u662f\u786e\u5b9a\u836f\u7269\u5bf9\u6cbb\u7597\u75be\u75c5\u6216\u75c5\u75c7\u7684\u5e2e\u52a9\u7a0b\u5ea6\uff0c\u4ee5\u53ca\u4eba\u4eec\u670d\u7528\u8be5\u836f\u7269\u53ef\u80fd\u4f1a\u4ea7\u751f\u54ea\u4e9b\u526f\u4f5c\u7528\u3002<\/p>\n

3 \u671f\u7814\u7a76\u6700\u591a\u53ef\u5305\u62ec 3,000 \u540d\u60a3\u6709\u6b63\u5728\u7814\u7a76\u7684\u75be\u75c5\u6216\u75c5\u75c7\u7684\u4eba\u3002\u8fd9\u4e9b\u7814\u7a76\u8bc1\u5b9e\u4e86\u8fd9\u79cd\u6cbb\u7597\u6709\u591a\u5927\u5e2e\u52a9\uff0c\u4ee5\u53ca\u5b83\u53ef\u80fd\u4ea7\u751f\u4ec0\u4e48\u526f\u4f5c\u7528\uff0c\u4f46\u89c4\u6a21\u66f4\u5927\uff0c\u56e0\u4e3a\u5b83\u4eec\u65e8\u5728\u5bf9\u836f\u7269\u5bf9\u60a3\u8005\u7684\u76ca\u5904\u8fdb\u884c\u660e\u786e\u8bc4\u4f30\u3002<\/p>\n

\u5982\u524d\u6240\u8ff0\uff0c\u5fc3\u7406\u5065\u5eb7\u6cbb\u7597\u7684\u6709\u6548\u6027\u662f\u901a\u8fc7\u5728\u6574\u4e2a\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u8fdb\u884c\u7684\u95ee\u5377\u8c03\u67e5\u6765\u8861\u91cf\u7684\u3002\u8fd9\u6709\u52a9\u4e8e\u786e\u5b9a\u4eba\u4eec\u968f\u7740\u65f6\u95f4\u7684\u63a8\u79fb\u670d\u7528\u836f\u7269\u662f\u5426\u611f\u89c9\u66f4\u597d\u3002<\/p>\n

4. FDA \u5ba1\u67e5\uff1a<\/strong> \u4e00\u65e6\u6240\u9700\u7684\u7814\u7a76\u5b8c\u6210\uff0c\u5e76\u4e14\u5982\u679c\u5b83\u652f\u6301\u4e00\u79cd\u836f\u7269\u5bf9\u5176\u9884\u671f\u7528\u9014\u5b89\u5168\u6709\u6548\uff0c\u516c\u53f8\u5c31\u53ef\u4ee5\u5411 FDA \u63d0\u4ea4\u7533\u8bf7\u4ee5\u4f9b\u5ba1\u67e5\u3002\u7136\u540e FDA \u51b3\u5b9a\u662f\u5426\u6279\u51c6\u8be5\u836f\u7269\u3002<\/p>\n

5. FDA \u4e0a\u5e02\u540e\u5b89\u5168\u76d1\u6d4b\uff1a<\/strong> \u4e00\u65e6\u8be5\u836f\u7269\u83b7\u5f97 FDA \u6279\u51c6\u5e76\u53ef\u4f9b\u60a3\u8005\u4f7f\u7528\uff0cFDA \u548c\u9500\u552e\u8be5\u836f\u7269\u7684\u516c\u53f8\u5c06\u7ee7\u7eed\u76d1\u6d4b\u8be5\u836f\u7269\u7684\u5b89\u5168\u6027\uff0c\u4ee5\u786e\u4fdd\u5176\u9002\u5408\u7ee7\u7eed\u4f7f\u7528\u3002<\/p>\n

\u6b63\u5982\u8be5\u8fc7\u7a0b\u6240\u5f3a\u8c03\u7684\u90a3\u6837\uff0c\u6210\u529f\u5f00\u53d1\u65b0\u836f\u9700\u8981\u575a\u6301\u4e0d\u61c8\u7684\u5949\u732e\u7cbe\u795e\u3002\u5c3d\u7ba1\u5f00\u53d1\u7cbe\u795e\u75be\u75c5\u6cbb\u7597\u65b9\u6cd5\u7684\u9053\u8def\u5386\u6765\u5145\u6ee1\u6311\u6218\uff0c\u4f46\u6211\u548c\u6211\u5728 Karuna \u7684\u540c\u4e8b\u5e76\u6ca1\u6709\u88ab\u5413\u5012\u3002\u4f5c\u4e3a\u4e00\u540d\u533b\u751f\u548c\u836f\u7269\u5f00\u53d1\u4eba\u5458\uff0c\u6211\u7684\u804c\u4e1a\u751f\u6daf\u7ee7\u7eed\u52a0\u5f3a\u4e86\u6211\u5bf9\u7cbe\u795e\u75c5\u5b66\u4e34\u5e8a\u7814\u7a76\u7684\u6295\u5165\uff0c\u56e0\u4e3a\u8fd9\u5bf9\u4e8e\u4e3a\u6709\u9700\u8981\u7684\u4eba\u63a8\u8fdb\u65b0\u7684\u66f4\u6709\u6548\u7684\u6cbb\u7597\u65b9\u6cd5\u81f3\u5173\u91cd\u8981\u3002<\/p>\n

1. \u533b\u836f\u5236\u9020\u5546\u534f\u4f1a\u3002 \u751f\u7269\u5236\u836f\u7814\u53d1\uff1a\u65b0\u836f\u80cc\u540e\u7684\u8fc7\u7a0b<\/em>.\u7f8e\u56fd\u533b\u5b66\u4f1a\uff0c2015 \u5e74\u3002
\nhttp:\/\/phrma-docs.phrma.org\/sites\/default\/files\/pdf\/rd_brochure_022307.pdf<\/a>.<\/p>\n

2. Opler\u3001Mark GA\u3001Christian Yavorsky \u548c David G. Daniel\u3002 \u201c\u9633\u6027\u548c\u9634\u6027\u7efc\u5408\u75c7\u91cf\u8868 (PANSS) \u57f9\u8bad\u3002\u201d \u4e34\u5e8a\u795e\u7ecf\u79d1\u5b66\u7684\u521b\u65b0<\/em>\u00a014\uff082017 \u5e74 12 \u6708 1 \u65e5\uff09\uff1a77-81\u3002<\/p>\n

3.\u201c\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u201d\u3002\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u3002 FDA\uff0c2018 \u5e74 1 \u6708 4 \u65e5\u3002
\nhttps:\/\/www.fda.gov\/patients\/learn-about-drug-and-device-approvals\/drug-development-process<\/a>.<\/p>\n

4. Lowe, Derek\u3002 \u201c\u6700\u65b0\u7684\u836f\u7269\u5931\u8d25\u548c\u6279\u51c6\u7387\u3002\u201d\u79d1\u5b66\u8f6c\u5316\u533b\u5b66\uff0c2019 \u5e74 5 \u6708 9 \u65e5\u3002
\nhttps:\/\/blogs.sciencemag.org\/pipeline\/archives\/2019\/05\/09\/the-latest-on-drug-failure-and-approval-rates<\/a>.<\/p>\n

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

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