{"id":57492,"date":"2018-10-11T01:00:00","date_gmt":"2018-12-07T02:23:43","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/33c75ff898\/"},"modified":"2018-12-07T10:23:43","modified_gmt":"2018-12-07T02:23:43","slug":"33c75ff898","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57492\/","title":{"rendered":"FDA\u4e3a\u900f\u76ae\u7ed9\u836f\u6216\u5c40\u90e8\u4f20\u8f93\u7cfb\u7edf\uff08TDS\uff09\u7684\u590d\u6742\u4eff\u5236\u836f\u63a8\u51fa\u65b0\u6307\u5357\u8349\u6848"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><span style=\"font-size: 12px;text-decoration: underline;color: rgb(136, 136, 136);\">\u6765\u6e90\uff1aHPC\u836f\u95fb\u836f\u4e8b<\/span><\/p>\n<p><br  \/><\/p>\n<p>\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff0910\u67089\u65e5\uff0c\u516c\u5e03\u4e86\u4e00\u4efd\u4fee\u8ba2\u540e\u7684\u6307\u5bfc\u8349\u6848\u548c\u4e00\u4efd\u65b0\u7684\u6307\u5bfc\u8349\u6848\uff0c\u4ee5\u5e2e\u52a9\u63a8\u8fdb\u7ecf\u900f\u76ae\u7ed9\u836f\u6216\u5c40\u90e8\u4f20\u8f93\u7cfb\u7edf\uff08topical delivery systems \uff0cTDS\uff09\u4eff\u5236\u836f\u7684\u5f00\u53d1\u3002<\/p>\n<p><br  \/><\/p>\n<p>TDS\u4ea7\u54c1\u5e94\u7528\u4e8e\u60a3\u8005\u7684\u76ae\u80a4\u3002\u60a3\u8005\u5e0c\u671b\u5373\u4f7f\u5176\u76ae\u80a4\u66b4\u9732\u5728\u6c34\u6216\u6e7f\u6c14\u4e2d\u6216\u5904\u4e8e\u8fd0\u52a8\u72b6\u6001\uff0c\u8fd9\u4e9b\u836f\u7269\u4e5f\u80fd\u591f\u7531\u9884\u671f\u4e00\u6837\u6301\u7eed\u5730\u63d0\u4f9b\u9002\u5f53\u7684\u836f\u7269\u5242\u91cf\uff0c\u5e76\u5728\u9884\u671f\u7684\u65f6\u95f4\u5185\uff0c\u540c\u65f6\u6301\u7eed\u5747\u5300\u5730\u9644\u7740\u5728\u76ae\u80a4\u4e0a\u3002<\/p>\n<p><br  \/><\/p>\n<p>FDA\u5c40\u957fScottGottlieb\u8bf4\uff1a\u201c\u7531\u4e8e\u901a\u8fc7TDS\u9012\u9001\u836f\u7269\u7684\u5185\u5728\u590d\u6742\u6027\uff0c\u5236\u9020\u8fd9\u4e9b\u590d\u6742\u836f\u7269\u7684\u4eff\u5236\u836f\u53ef\u80fd\u4f1a\u7279\u522b\u56f0\u96be\u3002\u201d\u4ed6\u6307\u51fa\uff0c\u8bb8\u591aTDS\u4ea7\u54c1\uff0c\u6bd4\u5982\u836f\u7269\u8d34\u7247\uff0c\u5e76\u6ca1\u6709\u9762\u4e34\u53ca\u65f6\u7684\u4eff\u5236\u836f\u7ade\u4e89\u3002<\/p>\n<p><br  \/><\/p>\n<p>\u4ed6\u8865\u5145\u8bf4\uff0c\u5176\u4ed6\u5e2e\u52a9\u590d\u6742\u4eff\u5236\u836f\u7684\u65b0\u653f\u7b56\u5305\u62ec\u5f00\u53d1\u201c\u65b0\u7684\u5206\u6790\u5de5\u5177\u548c\u4f53\u5916\u8bd5\u9a8c\uff0c\u8fd9\u4e9b\u5de5\u5177\u53ef\u80fd\u66f4\u51c6\u786e\u3001\u66f4\u654f\u611f\uff0c\u800c\u4e14\u53ef\u518d\u751f\u7684\u5de5\u5177\u53ef\u4ee5\u8bc1\u660e\u4eff\u5236\u836f\u548c\u54c1\u724c\u836f\u4e4b\u95f4\u7684\u76f8\u4f3c\u6027\u3002\u201d\u6211\u4eec\u8fd8\u5c06\u53d1\u5e03\u4e00\u4e2a\u603b\u62ec\u6027\u7684\u6307\u5bfc\u610f\u89c1\uff0c\u5e2e\u52a9\u4eff\u5236\u836f\u5f00\u53d1\u8005\u89e3\u51b3\u4ed6\u4eec\u5728\u8bd5\u56fe\u5236\u4f5c\u590d\u6742\u836f\u7269\u4eff\u5236\u836f\u65f6\u9047\u5230\u7684\u4e00\u4e9b\u6700\u5177\u6311\u6218\u6027\u7684\u76d1\u7ba1\u548c\u79d1\u5b66\u95ee\u9898\u3002\u8fd9\u4e00\u603b\u6269\u6027\u6307\u5bfc\u4e4b\u540e\uff0c\u5c06\u4f1a\u6709\u4e00\u7cfb\u5217\u66f4\u6709\u9488\u5bf9\u6027\u7684\u6307\u5bfc\uff0c\u4ee5\u5e2e\u52a9\u89e3\u51b3\u53ef\u80fd\u963b\u788d\u4eff\u5236\u836f\u7ade\u4e89\u7684\u6cd5\u5f8b\u95ee\u9898\u3002\u201d<\/p>\n<p><br  \/><\/p>\n<p><strong>\u523a\u6fc0\u6027\u548c\u81f4\u654f\u6027<\/strong><\/p>\n<p><br  \/><\/p>\n<p>\u8fd9\u4efd\u957f\u8fbe12\u9875\u7684\u6307\u5357\u4e3a\u7b80\u5316\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u63d0\u4f9b\u4e86\u5efa\u8bae\uff0c\u4ee5\u8bc4\u4f30\u4e00\u79cd\u62df\u900f\u76ae\u6216\u5c40\u90e8\u4f20\u8f93\u7cfb\u7edf\uff08TDS\uff09\u7684\u4f53\u5185\u76ae\u80a4\u523a\u6fc0\u548c\u654f\u5316\uff08i\/s\uff09\u6f5c\u529b\u7684\u7814\u7a76\u3002<\/p>\n<p>\u7533\u8bf7\u4eba\u5e94\u4f7f\u7528\u9002\u5f53\u8bbe\u8ba1\u7684\u76ae\u80a4I\/S\u7814\u7a76\u4e0e\u4eba\u7c7b\u53d7\u8bd5\u8005\uff08\u8349\u6848\u6ce8\u91ca\uff09\u5bf9\u4eff\u5236\u836f\u548c\u53c2\u6bd4TDS\u4ea7\u54c1\u8fdb\u884c\u6bd4\u8f83\u8bc4\u4f30\uff0c\u4ee5\u8bc1\u660e\u4e0eT TDS\u53d1\u751f\u76ae\u80a4\u523a\u6fc0\u6216\u81f4\u654f\u53cd\u5e94\u7684\u53ef\u80fd\u6027\u4e0d\u6bd4\u7528R TDS\u89c2\u5bdf\u5230\u7684\u53cd\u5e94\u5dee\u3002<\/p>\n<p><br  \/><\/p>\n<p>\u7814\u7a76\u7684\u8bbe\u8ba1\u548c\u5b9e\u65bd\u3001\u7edf\u8ba1\u5206\u6790\u7684\u8003\u8651\u3001\u4e0d\u826f\u4e8b\u4ef6\u6570\u636e\u7684\u603b\u4f53\u8bc4\u4f30\u548c\u6570\u636e\u63d0\u4ea4\u7684\u683c\u5f0f\u90fd\u5728\u6307\u5357\u8349\u6848\u4e2d\u5217\u51fa\u3002<\/p>\n<p><br  \/><\/p>\n<p>\u8be5\u673a\u6784\u8865\u5145\u8bf4\uff1a\u201c\u672c\u6307\u5357\u4e2d\u63cf\u8ff0\u7684\u4e0eI\/S\u7814\u7a76\u7684\u8bbe\u8ba1\u548c\u5b9e\u65bd\u6709\u5173\u7684\u5efa\u8bae\u53d6\u4ee3\u4e86\u5728\u672c\u6307\u5357\u4e4b\u524d\u516c\u5e03\u7684\u4ea7\u54c1\u7279\u5b9a\u6307\u5357\u4e2d\u63d0\u4f9b\u7684\u4e0eI\/S\u7814\u7a76\u76f8\u5173\u7684\u5efa\u8bae\u3002\u201d<\/p>\n<p><br  \/><\/p>\n<p><strong>\u8bc4\u4f30\u9644\u7740\u529b<\/strong><\/p>\n<p><br  \/><\/p>\n<p>\u8fd9\u4efd\u4fee\u8ba2\u540e\u76849\u9875\u8349\u6848\u5c06\u53d6\u4ee32016\u5e746\u6708\u7684\u8349\u6848\uff0c\u5e76\u4e3a\u8bc4\u4f30TDS\u7684\u7c98\u5408\u5242\u6027\u80fd\u7684\u7814\u7a76\u8bbe\u8ba1\u548c\u5b9e\u65bd\u63d0\u4f9b\u5efa\u8bae\u3002<\/p>\n<p><br  \/><\/p>\n<p>\u201c\u6839\u636eTDS\u4ea7\u54c1\u5f00\u53d1\u8ba1\u5212\u7684\u76ee\u6807\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u9009\u62e9\u5728\u8fdb\u884c\u7684\u4ec5\u8bc4\u4f30TDS\u7c98\u9644\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\u6216\u5728\u4ee5\u8054\u5408\u76ee\u7684\u8fdb\u884c\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\u8bc4\u4f30TDS\u7c98\u9644\uff08\u4f8b\u5982\uff0c\u7528\u4e8e\u540c\u65f6\u8bc4\u4f30\u7c98\u9644\u548c\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u4e0e\u836f\u4ee3\u52a8\u529b\u5b66\uff08PK\uff09\u7ec8\u70b9\uff09\uff0c\u201d\u4fee\u8ba2\u8349\u6848\u6307\u51fa\u3002<\/p>\n<p>\u4fee\u8ba2\u8349\u6848\u4e2d\u6d89\u53ca\u7684\u4e3b\u9898\u5305\u62ec\u7814\u7a76\u7684\u8bbe\u8ba1\u548c\u5b9e\u65bd\u3001\u7edf\u8ba1\u5206\u6790\u7684\u8003\u8651\u56e0\u7d20\uff0c\u4ee5\u53ca\u5bf9\u9644\u7740\u529b\u548c\u751f\u7269\u7b49\u6548\u6027\u7684\u7efc\u5408\u8bc4\u4ef7\u7684\u5efa\u8bae\u3002<\/p>\n<p style=\"text-align: right;\"><span style=\"font-size: 12px;color: rgb(102, 102, 102);font-family: &quot;Microsoft YaHei&quot;, \u5fae\u8f6f\u96c5\u9ed1, Simsun, \u5b8b\u4f53;text-indent: 32px;background-color: rgb(255, 255, 255);\"><br  \/><\/span><\/p>\n<p style=\"text-align: left;\"><span style=\"font-size: 12px;color: rgb(102, 102, 102);font-family: &quot;Microsoft YaHei&quot;, \u5fae\u8f6f\u96c5\u9ed1, Simsun, \u5b8b\u4f53;text-indent: 32px;background-color: rgb(255, 255, 255);\">\uff08\u539f\u6807\u9898\uff1a\u7f8e\u56fdFDA\u4e3a\u7279\u5b9a\u7ed9\u836f\u7cfb\u7edf\u7684\u590d\u6742\u4eff\u5236\u836f\u63a8\u51fa\u4e86\u65b0\u7684\u6307\u5357\u8349\u6848\uff09<\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"font-size: 12px;color: rgb(102, 102, 102);font-family: &quot;Microsoft YaHei&quot;, \u5fae\u8f6f\u96c5\u9ed1, Simsun, \u5b8b\u4f53;text-indent: 32px;background-color: rgb(255, 255, 255);\"><br  \/><\/span><\/p>\n<p style=\"text-align: center;\">\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6765\u6e90\uff1aHPC\u836f\u95fb\u836f\u4e8b \u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff0910\u67089\u65e5\uff0c\u516c\u5e03\u4e86\u4e00\u4efd\u4fee\u8ba2\u540e\u7684\u6307\u5bfc\u8349\u6848\u548c\u4e00\u4efd\u65b0\u7684\u6307\u5bfc\u8349\u6848\uff0c [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":57493,"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\/57492"}],"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=57492"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57492\/revisions"}],"predecessor-version":[{"id":57494,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57492\/revisions\/57494"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/57493"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=57492"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=57492"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=57492"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}