{"id":78271,"date":"2018-12-08T00:00:50","date_gmt":"2019-02-01T06:15:16","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/78271\/"},"modified":"2019-02-01T14:15:16","modified_gmt":"2019-02-01T06:15:16","slug":"af2c771292","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/78271\/","title":{"rendered":"\u91cd\u5e86\u836f\u53cb\u53c8\u4e00\u836f\u7269\u8fc7\u4e00\u81f4\u6027\u8bc4\u4ef7"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"text-align: justify;\">\u4e00\u3001\u6982\u51b5 \u8fd1\u65e5\uff0c\u4e0a\u6d77\u590d\u661f\u533b\u836f\uff08\u96c6\u56e2\uff09\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u672c\u516c\u53f8\u201d\uff09\u63a7\u80a1\u5b50\u516c\u53f8 \u91cd\u5e86\u836f\u53cb\u5236\u836f\u6709\u9650\u8d23\u4efb\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u91cd\u5e86\u836f\u53cb\u201d\uff09\u6536\u5230\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u9881\u53d1 \u7684\u5173\u4e8e\u6c2f\u5316\u94be\u9897\u7c92\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u8be5\u836f\u54c1\u201d\uff09\u7684\u300a\u836f\u54c1\u8865\u5145\u7533\u8bf7\u6279\u4ef6\u300b\uff08\u6279\u4ef6\u53f7\uff1a 2018B04281\u30012018B04282\uff09\uff0c\u8be5\u836f\u54c1\u901a\u8fc7\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u3002 \u4e8c\u3001\u8be5\u836f\u54c1\u7684\u57fa\u672c\u60c5\u51b5 \u836f\u54c1\u540d\u79f0\uff1a<span style=\"color: rgb(0, 82, 255);\"><strong>\u6c2f\u5316\u94be\u9897\u7c92<\/strong><\/span>\u5242\u578b\uff1a\u9897\u7c92\u5242 \u89c4\u683c\uff1a1.0g\u30011.5g \u6ce8\u518c\u5206\u7c7b\uff1a\u5316\u5b66\u836f\u54c1 \u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\uff1a\u91cd\u5e86\u836f\u53cb \u539f\u6279\u51c6\u6587\u53f7\uff1a\u56fd\u836f\u51c6\u5b57 H50020684\u3001H50020683 \u5ba1\u6279\u7ed3\u8bba\uff1a\u901a\u8fc7\u4eff\u5236\u836f\u8d28\u91cf\u548c\u7597\u6548\u4e00\u81f4\u6027\u8bc4\u4ef7 \u4e09\u3001\u8be5\u836f\u54c1\u7684\u76f8\u5173\u4fe1\u606f \u8be5\u836f\u54c1\u4e3b\u8981\u6cbb\u7597\u4f4e\u94be\u8840\u75c7\u3001\u9884\u9632\u4f4e\u94be\u8840\u75c7\uff0c\u5e76\u9002\u7528\u4e8e\u6d0b\u5730\u9ec4\u4e2d\u6bd2\u5f15\u8d77\u9891\u53d1\u6027\u3001 \u591a\u6e90\u6027\u65e9\u640f\u6216\u5feb\u901f\u5fc3\u5f8b\u5931\u5e38\u30022017 \u5e74\u5ea6\uff0c\u91cd\u5e86\u836f\u53cb\u8be5\u836f\u54c1\u4e8e\u4e2d\u56fd\u5883\u5185\uff08\u4e0d\u5305\u62ec\u6e2f\u6fb3 2 \u53f0\u5730\u533a\uff0c\u4e0b\u540c\uff09\u9500\u552e\u989d\u7ea6\u4e3a\u4eba\u6c11\u5e01 71 \u4e07\u5143\uff08\u672a\u7ecf\u5ba1\u8ba1\uff09\u3002 \u622a\u81f3\u672c\u516c\u544a\u65e5\uff0c\u4e8e\u4e2d\u56fd\u5883\u5185\u5df2\u4e0a\u5e02\u7684\u6c2f\u5316\u94be\u5236\u5242\u5305\u62ec\u4e2d\u56fd\u5927\u51a2\u5236\u836f\u6709\u9650\u516c\u53f8\u7684 \u6c2f\u5316\u94be\u6ce8\u5c04\u6db2\u3001\u5e7f\u5dde\u8a89\u4e1c\u5065\u5eb7\u5236\u836f\u6709\u9650\u516c\u53f8\u7684\u8865\u8fbe\u79c0\u00ae\u7b49\u3002\u6839\u636e IQVIA CHPA \u6700\u65b0\u6570 \u636e\uff08\u7531 IQVIA \u63d0\u4f9b\uff0cIQVIA \u662f\u5168\u7403\u9886\u5148\u7684\u533b\u836f\u5065\u5eb7\u4ea7\u4e1a\u4e13\u4e1a\u4fe1\u606f\u548c\u6218\u7565\u54a8\u8be2\u670d\u52a1\u63d0 \u4f9b\u5546\uff09\uff0c2017 \u5e74\u5ea6\uff0c\u6c2f\u5316\u94be\u5236\u5242\u4e8e\u4e2d\u56fd\u5883\u5185\u9500\u552e\u989d\u7ea6\u4e3a\u4eba\u6c11\u5e01 4.9 \u4ebf\u5143\u3002<strong><span style=\"color: rgb(0, 82, 255);\">\u622a\u81f3 2018 \u5e74 10 \u6708\uff0c\u672c\u96c6\u56e2\uff08\u5373\u672c\u516c\u53f8\u53ca\u63a7\u80a1\u5b50\u516c\u53f8\/\u5355\u4f4d\uff09\u73b0\u9636\u6bb5\u9488\u5bf9\u8be5\u836f\u54c1 \u4e00\u81f4\u6027\u8bc4\u4ef7\u5df2\u6295\u5165\u7814\u53d1\u8d39\u7528\u4eba\u6c11\u5e01\u7ea6 154 \u4e07\u5143\uff08\u672a\u7ecf\u5ba1\u8ba1\uff09\u3002<\/span><\/strong><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(255, 76, 0);\"><strong><br  \/><\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(255, 76, 0);\"><strong>\u5ef6\u4f38\u9605\u8bfb<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: rgb(0, 0, 0);\"><strong>\u8fd1\u65e5\uff0c<\/strong><strong>\u4eba\u798f\u533b\u836f\u96c6\u56e2\u80a1\u4efd\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u516c\u53f8\u201d\u6216\u201c\u4eba\u798f\u533b\u836f\u201d\uff09\u5168\u8d44\u5b50\u516c\u53f8Epic Pharma, LLC\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cEpic Pharma\u201d\uff09\u6536\u5230\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5173\u4e8e\u6c2f \u5316\u94be\u7c89\u7684\u6279\u51c6\u6587\u53f7\uff0c\u73b0\u5c06\u4e3b\u8981\u60c5\u51b5\u516c\u544a\u5982\u4e0b\uff1a \u836f\u54c1\u540d\u79f0\uff1a<\/strong><\/span><span style=\"color: rgb(0, 82, 255);\"><strong>Potassium Chloride for Oral Solution USP\uff08\u6c2f\u5316\u94be\u7c89\uff09<\/strong><\/span><span style=\"color: rgb(0, 0, 0);\"><strong>\u7533\u8bf7\u4e8b\u9879\uff1aANDA\uff08\u7f8e\u56fd\u65b0\u836f\u7b80\u7565\u7533\u8bf7\uff0c\u5373\u7f8e\u56fd\u4eff\u5236\u836f\u7533\u8bf7\u3002ANDA\u83b7\u5f97\u7f8e\u56fdFDA \u5ba1\u8bc4\u6279\u51c6\u610f\u5473\u7740\u7533\u8bf7\u8005\u53ef\u4ee5\u751f\u4ea7\u5e76\u5728\u7f8e\u56fd\u5e02\u573a\u9500\u552e\u8be5\u4ea7\u54c1\u3002\uff09 ANDA\u6279\u4ef6\u53f7\uff1a210200 \u5242\u578b\uff1a\u7c89\u5242 \u89c4\u683c\uff1a20 mEq \u836f\u54c1\u7c7b\u578b\uff1a\u5904\u65b9\u836f \u6c2f\u5316\u94be\u7c89\u7528\u4e8e\u6cbb\u7597\u5404\u79cd\u539f\u56e0\u5f15\u8d77\u7684\u4f4e\u94be\u8840\u75c7\uff0c\u5982\u8fdb\u98df\u4e0d\u8db3\u3001\u5455\u5410\u3001\u4e25\u91cd\u8179\u6cfb\u3001\u5e94\u7528 \u6392\u94be\u5229\u5c3f\u836f\u3001\u4f4e\u94be\u6027\u5bb6\u65cf\u5468\u671f\u6027\u9ebb\u75f9\u3001\u957f\u671f\u5e94\u7528\u7cd6\u76ae\u8d28\u6fc0\u7d20\u548c\u8865\u5145\u9ad8\u6e17\u8461\u8404\u7cd6\u7b49\u3002Epic Pharma\u4e8e2017\u5e74\u63d0\u4ea4\u6c2f\u5316\u94be\u7c89\u7684ANDA\u7533\u8bf7\uff0c\u7d2f\u8ba1\u7814\u53d1\u6295\u5165\u7ea6\u4e3a70\u4e07\u7f8e\u5143\u3002\u6839\u636eIMS\u6570\u636e \u7edf\u8ba1\uff0c2017\u5e74\u5ea6\u6c2f\u5316\u94be\u7c89\u5728\u7f8e\u56fd\u5e02\u573a\u7684\u603b\u9500\u552e\u989d\u7ea6\u4e3a1\u4ebf\u7f8e\u5143\uff0c\u4e3b\u8981\u751f\u4ea7\u5382\u5546\u5305\u62ecNovartis\u3001 Virtus Pharma\u3001Endo Pharma\u7b49\u3002\u56fd\u5185\u76ee\u524d\u5c1a\u65e0\u540c\u5242\u578b\u4ea7\u54c1\u4e0a\u5e02\uff0c\u6839\u636e\u7c73\u5185\u7f51\u6570\u636e\u7edf\u8ba1\uff0c 2017\u5e74\u5ea6\u6c2f\u5316\u94be\u6240\u6709\u5242\u578b\u5728\u6211\u56fd\u57ce\u5e02\u3001\u53bf\u7ea7\u53ca\u4e61\u9547\u4e09\u5927\u7ec8\u7aef\u516c\u7acb\u533b\u9662\u7684\u9500\u552e\u989d\u7ea6\u4e3a7\u4ebf\u5143 \u4eba\u6c11\u5e01\uff0c\u4e3b\u8981\u5382\u5546\u5305\u62ec\u4e2d\u56fd\u5927\u51a2\u5236\u836f\u6709\u9650\u516c\u53f8\u3001\u6e56\u5317\u79d1\u4f26\u836f\u4e1a\u6709\u9650\u516c\u53f8\u3001\u5e7f\u5dde\u8a89\u4e1c\u5065\u5eb7 \u5236\u836f\u6709\u9650\u516c\u53f8\u7b49\u3002 \u672c\u6b21\u6c2f\u5316\u94be\u7c89\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u6587\u53f7\u6807\u5fd7\u7740Epic Pharma\u5177\u5907\u4e86\u5728\u7f8e\u56fd\u5e02\u573a\u9500\u552e\u8be5\u4ea7 \u54c1\u7684\u8d44\u683c\uff0c\u5c06\u5bf9\u516c\u53f8\u62d3\u5c55\u7f8e\u56fd\u4eff\u5236\u836f\u5e02\u573a\u5e26\u6765\u79ef\u6781\u7684\u5f71\u54cd\uff0c\u516c\u53f8\u540e\u7eed\u5c06\u79ef\u6781\u63a8\u8fdb\u8be5\u4ea7\u54c1 \u7279 \u522b \u63d0 \u793a \u672c\u516c\u53f8\u8463\u4e8b\u4f1a\u53ca\u5168\u4f53\u8463\u4e8b\u4fdd\u8bc1\u672c\u516c\u544a\u5185\u5bb9\u4e0d\u5b58\u5728\u4efb\u4f55\u865a\u5047\u8bb0\u8f7d\u3001\u8bef\u5bfc \u6027\u9648\u8ff0\u6216\u8005\u91cd\u5927\u9057\u6f0f\uff0c\u5e76\u5bf9\u5176\u5185\u5bb9\u7684\u771f\u5b9e\u6027\u3001\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\u627f\u62c5\u4e2a\u522b\u53ca \u8fde\u5e26\u8d23\u4efb\u3002 \u5728\u7f8e\u56fd\u5e02\u573a\u7684\u4e0a\u5e02\u51c6\u5907\u5de5\u4f5c\u3002<\/strong><\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u4e00\u3001\u6982\u51b5 \u8fd1\u65e5\uff0c\u4e0a\u6d77\u590d\u661f\u533b\u836f\uff08\u96c6\u56e2\uff09\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u672c\u516c\u53f8\u201d\uff09\u63a7\u80a1\u5b50\u516c\u53f8 \u91cd\u5e86\u836f\u53cb\u5236\u836f\u6709\u9650\u8d23\u4efb\u516c\u53f8\uff08\u4ee5 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":78272,"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\/78271"}],"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=78271"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/78271\/revisions"}],"predecessor-version":[{"id":78273,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/78271\/revisions\/78273"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/78272"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=78271"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=78271"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=78271"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}