{"id":5429,"date":"2020-08-30T18:53:23","date_gmt":"2020-08-30T22:53:23","guid":{"rendered":"https:\/\/www.yibababa.com\/?p=5429"},"modified":"2020-08-30T18:53:23","modified_gmt":"2020-08-30T22:53:23","slug":"%e7%96%ab%e8%8b%97%e6%88%96%e6%96%b0%e8%8d%af%e5%9c%a8%e7%be%8e%e5%9b%bd%e4%b8%8a%e5%b8%82%e9%94%80%e5%94%ae-%e9%9c%80%e8%a6%81%e7%bb%8f%e8%bf%87%e5%93%aa%e4%ba%9b%e4%b8%b4%e5%ba%8a%e5%92%8c%e5%ae%a1","status":"publish","type":"post","link":"https:\/\/yibababa.com\/article\/archives\/5429","title":{"rendered":"\u75ab\u82d7\u6216\u65b0\u836f\u5728\u7f8e\u56fd\u4e0a\u5e02\u9500\u552e \u9700\u8981\u7ecf\u8fc7\u54ea\u4e9b\u6b65\u9aa4"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-large\" src=\"https:\/\/www.reviewofoptometry.com\/CMSImagesContent\/2013\/6\/027_ro0613_f1.jpg\" alt=\"\" width=\"600\" height=\"386\" \/><\/p>\n<p>\u5728\u7f8e\u56fd\uff0c\u6240\u6709\u65b0\u7684\u836f\u54c1\uff08\u5305\u62ec\u75ab\u82d7\uff09\u3001\u533b\u7597\u8bbe\u5907\u548c\u6cbb\u7597\u65b9\u6cd5\u90fd\u8981\u7ecf\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u548cFDA\u7684\u5ba1\u6279\u540c\u610f\u540e\u624d\u80fd\u6b63\u5f0f\u4e0a\u5e02\u9500\u552e\u548c\u4f7f\u7528\u3002<\/p>\n<p>\u90a3\u4e48\uff0c\u4e00\u79cd\u65b0\u836f\uff08\u75ab\u82d7\uff09\u4ece\u4e34\u5e8a\u8bd5\u9a8c\u5230\u4e0a\u5e02\u9500\u552e\uff0c\u8981\u7ecf\u8fc7\u54ea\u4e9b\u8fc7\u7a0b\u5462\uff1f<\/p>\n<p style=\"text-align: left; padding-left: 30px;\">1\u3001<span style=\"color: #ff0000;\">Pre-clinical stage \u4e34\u5e8a\u524d\u7814\u7a76\u9636\u6bb5<\/span>\uff0c\u4e34\u5e8a\u524d\u7814\u7a76\u4f7f\u7528\u7ec4\u7ec7\u57f9\u517b\u6216\u7ec6\u80de\u57f9\u517b\uff0c\u4ee5\u53ca\u52a8\u7269\u8bd5\u9a8c\u6765\u8bc4\u4f30\u75ab\u82d7\u7684\u5b89\u5168\u6027\u53ca\u5176\u514d\u75ab\u539f\u6027\u6216\u5f15\u8d77\u514d\u75ab\u53cd\u5e94\u7684\u80fd\u529b\u3002<\/p>\n<p style=\"text-align: left; padding-left: 30px;\">2\u3001Investigational New Drug application\uff08IND\uff09 \u7814\u7a76\u578b\u65b0\u836f\u7533\u8bf7\uff0c\u4e5f\u5c31\u662f\u836f\u5382\u5411\u7f8e\u56fdFDA\u63d0\u51fa\u7814\u7a76\u65b0\u836f\u7533\u8bf7\u3002<\/p>\n<p style=\"padding-left: 30px;\">3\u3001Phase I Vaccine Trials \u4e34\u5e8a\u8bd5\u9a8c\u4e00\u671f\uff0c\u4e00\u5c0f\u7fa4\uff08\u4e00\u822c\u51e0\u5341\u4eba\uff09\u6210\u5e74\u4eba\u63a5\u53d7\u75ab\u82d7\u8bd5\u9a8c\uff0c\u901a\u5e38\u572820-80\u540d\u53d7\u8bd5\u8005\u4e4b\u95f4\u3002 \u5982\u679c\u75ab\u82d7\u662f\u9488\u5bf9\u513f\u7ae5\u7684\uff0c\u7814\u7a76\u4eba\u5458\u5c06\u9996\u5148\u5bf9\u6210\u5e74\u4eba\u8fdb\u884c\u6d4b\u8bd5\uff0c\u7136\u540e\u9010\u6b65\u964d\u4f4e\u6d4b\u8bd5\u5bf9\u8c61\u7684\u5e74\u9f84\uff0c\u76f4\u5230\u4ed6\u4eec\u8fbe\u5230\u76ee\u6807\u4e3a\u6b62\u3002<\/p>\n<p style=\"padding-left: 30px;\">4\u3001Phase II Vaccine Trials\u00a0\u4e34\u5e8a\u8bd5\u9a8c\u4e8c\u671f\uff0c\u6269\u5927\u4e34\u5e8a\u7814\u7a76\u8303\u56f4\uff08\u4e00\u822c\u4e3a\u51e0\u767e\u4eba\uff09\uff0c\u5e76\u5411\u5177\u6709\u4e0e\u65b0\u75ab\u82d7\u76f8\u4f3c\u7684\u7279\u5f81\uff08\u4f8b\u5982\u5e74\u9f84\u548c\u8eab\u4f53\u5065\u5eb7\uff09\u7684\u4eba\u7fa4\u63d0\u4f9b\u75ab\u82d7\u8bd5\u9a8c\u3002II\u671f\u4e34\u5e8a\u6d4b\u8bd5\u7684\u76ee\u7684\u662f\u7814\u7a76\u75ab\u82d7\u7684\u5b89\u5168\u6027\u3001\u514d\u75ab\u539f\u6027\u3001\u5efa\u8bae\u7684\u5242\u91cf\u3001\u514d\u75ab\u65f6\u95f4\u8868\u7b49\u3002<\/p>\n<p style=\"padding-left: 30px;\">5\u3001Phase III Vaccine Trials \u4e34\u5e8a\u8bd5\u9a8c\u4e09\u671f\uff0c\u63d0\u4f9b\u75ab\u82d7\u7ed9\u51e0\u5343\u5230\u4e0a\u4e07\u7684\u4eba\u6d4b\u8bd5\uff0c\u5e76\u8fdb\u884c\u529f\u6548\u548c\u5b89\u5168\u6027\u6d4b\u8bd5\u3002III\u671f\u8bd5\u9a8c\u662f\u968f\u673a\u4e14\u53cc\u76f2\u7684\u3002<\/p>\n<p style=\"padding-left: 30px;\">6\u3001\u4e0a\u5e02\u6279\u51c6\uff0c\u5728\u6210\u529f\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e4b\u540e\uff0c\u75ab\u82d7\u5f00\u53d1\u516c\u53f8\u5c06\u5411FDA\u63d0\u4ea4\u300a\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\u300b\u3002 \u7136\u540e\uff0cFDA\u5c06\u68c0\u67e5\u751f\u4ea7\u75ab\u82d7\u7684\u5de5\u5382\uff0c\u5e76\u6279\u51c6\u75ab\u82d7\u7684\u6807\u7b7e\u3002<span style=\"color: #ff0000;\">\u75ab\u82d7\u6b63\u5f0f\u53ef\u4ee5\u4e0a\u5e02\u9500\u552e<\/span>\u3002<\/p>\n<p style=\"padding-left: 30px;\">\u75ab\u82d7\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u540e\uff0cFDA\u5c06\u7ee7\u7eed\u76d1\u89c6\u75ab\u82d7\u7684\u751f\u4ea7\uff0c\u5305\u62ec\u68c0\u67e5\u8bbe\u65bd\u5e76\u5ba1\u67e5\u5236\u9020\u5546\u5bf9\u8bb8\u591a\u75ab\u82d7\u7684\u6548\u529b\u3001\u5b89\u5168\u6027\u548c\u7eaf\u5ea6\u7684\u6d4b\u8bd5\u3002 FDA\u6709\u6743\u5bf9\u5236\u9020\u5546\u7684\u75ab\u82d7\u8fdb\u884c\u81ea\u5df1\u7684\u6d4b\u8bd5\u3002<\/p>\n<p style=\"padding-left: 30px;\">7\u3001Post-Licensure Monitoring of Vaccines\u00a0\u75ab\u82d7\u7684\u6279\u51c6\u6388\u6743\u540e\u76d1\u6d4b\uff0c\u6279\u51c6\u75ab\u82d7\u540e\uff0cFDA\u8fd8\u5c06\u591a\u65b9\u4f4d\u76d1\u63a7\u75ab\u82d7\uff0c\u5305\u62ecIV\u671f\u8bd5\u9a8c\u3001\u75ab\u82d7\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u7cfb\u7edf\u548c\u75ab\u82d7\u5b89\u5168\u6027\u6570\u636e\u6536\u96c6\u5bf9\u6bd4\u7b49\u3002<\/p>\n<p style=\"padding-left: 30px;\">8\u3001Phase IV Trials\u00a0\u7b2c\u56db\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff08\u975e\u5f3a\u5236\u6027\uff09\uff0c\u5927\u90e8\u5206\u836f\u5382\u5728\u75ab\u82d7\u4e0a\u5e02\u540e\u8fd8\u4f1a<span style=\"color: #ff0000;\">\u9009\u62e9\u6027<\/span>\u7ee7\u7eed\u8fdb\u884c\u7b2c\u56db\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6765\u6d4b\u8bd5\u75ab\u82d7\u7684\u5b89\u5168\u6027\u3001\u529f\u6548\u548c\u5176\u4ed6\u6f5c\u5728\u7528\u9014\u3002<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: left;\">\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5728\u7f8e\u56fd\uff0c\u6240\u6709\u65b0\u7684\u836f\u54c1\uff08\u5305\u62ec\u75ab\u82d7\uff09\u3001\u533b\u7597\u8bbe\u5907\u548c\u6cbb\u7597\u65b9\u6cd5\u90fd\u8981\u7ecf\u8fc7\u4e34\u5e8a\u8bd5\u9a8c\u548cFDA\u7684\u5ba1 &hellip; <a href=\"https:\/\/yibababa.com\/article\/archives\/5429\">\u7ee7\u7eed\u9605\u8bfb <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5429","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/posts\/5429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/comments?post=5429"}],"version-history":[{"count":0,"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/posts\/5429\/revisions"}],"wp:attachment":[{"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/media?parent=5429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/categories?post=5429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/yibababa.com\/article\/wp-json\/wp\/v2\/tags?post=5429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}