{"id":60331,"date":"2018-11-20T01:00:00","date_gmt":"2018-12-07T02:55:52","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/1476f2c3a9\/"},"modified":"2018-12-07T10:55:54","modified_gmt":"2018-12-07T02:55:54","slug":"1476f2c3a9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/60331\/","title":{"rendered":"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><br  \/><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/1-1544151353.jpg\" alt=\"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f\" title=\"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f\"  \/><\/p>\n<p><strong>1.<\/strong>\u6839\u636e<span style=\"text-decoration: underline;\">\u836f\u878d\u6570\u636e\uff0cPharnex Datamonitor<\/span><span style=\"text-decoration: none;\">2018\u5e7411\u670820\u65e5<\/span>\u76d1\u6d4b\uff1a<\/p>\n<p><br  \/><\/p>\n<p><strong>2.<\/strong>\u534e\u6d77\u836f\u4e1a\u7f2c\u6c99\u5766\u6c22\u6c2f\u567b\u55ea\u7247\u83b7\u5f97\u6211\u56fdCDE\u53d1\u653e\u7684<strong>\u4e34\u5e8a\u8bd5\u9a8c\u901a\u77e5\u4e66<\/strong>\u3002\u672c\u53d7\u7406\u53f7\u4e8e2017\u5e7411\u670817\u65e5\u63d0\u4ea44\u7c7b\u4eff\u5236\u836f\u4e0a\u5e02\u7533\u8bf7\u3002<\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/10-1544151353.jpg\" alt=\"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f\" title=\"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f\"  \/><\/p>\n<p><strong>3.<\/strong>\u5728\u7f8e\u56fd\uff0c\u534e\u6d77\u5b50\u516c\u53f8\u666e\u9716\u65af\u901a\uff08<span style=\"color: rgb(34, 34, 34);font-family: &quot;Helvetica Neue&quot;, Helvetica, Arial, sans-serif;font-size: 15.4px;background-color: rgb(255, 255, 255);\">PRINSTON PHARMACEUTICAL INC&nbsp;<\/span>\uff09\u4e8e2016\u5e742\u67088\u65e5\u591a\u4e2a\u89c4\u683c\u7684\u7f2c\u6c99\u5766\u6c22\u6c2f\u567b\u55ea\u7247\u83b7\u6279\u3002ANDA,<strong style=\"box-sizing: border-box;color: rgb(34, 34, 34);font-family: &quot;Helvetica Neue&quot;, Helvetica, Arial, sans-serif;font-size: 15.4px;white-space: normal;background-color: rgb(255, 255, 255);\">Application Number:<\/strong><span style=\"color: rgb(34, 34, 34);font-family: &quot;Helvetica Neue&quot;, Helvetica, Arial, sans-serif;font-size: 15.4px;background-color: rgb(255, 255, 255);\">&nbsp;A206083 \u3002<\/span><\/p>\n<p><br  \/><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/6-1544151354.jpg\" alt=\"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f\" title=\"\u91cd\u78c5\uff1a\u91cd\u65b0\u505aBE,\u56fd\u5916\u8f6c\u62a5\u7684ANDA\u53ef\u80fd\u662f\u4f2a\u547d\u9898\u5417\uff1f\"  \/><\/p>\n<p><br  \/><\/p>\n<p><strong>4.\u8f6c\u62a5\u4e4b\u8def\u4e0d\u6613\uff1a<\/strong><\/p>\n<p><br  \/><\/p>\n<p><strong>\u76d0\u9178\u5ea6\u6d1b\u897f\u6c40\u80a0\u6eb6\u80f6\u56ca<\/strong>\u4e5f\u662f\u8fd1\u671f\u83b7\u5f97\u4e34\u5e8a\u6279\u4ef6\uff0c\u9700\u8981\u91cd\u65b0\u505aBE\u3002<br  style=\"font-family: arial, \u5b8b\u4f53, serif;font-size: 12px;white-space: normal;background-color: rgb(255, 255, 255);\"  \/>\u5316\u5b66\u836f\u54c1\u7b2c\u20024\u2002\u7c7b \uff0c\u5ba1\u6279\u7ed3\u8bba\uff1a\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u54c1\u7ba1\u7406\u529e\u6cd5\u300b\uff0c\u7ecf\u5ba1\u67e5\uff0c<span style=\"text-decoration: underline;\">\u6279\u51c6\u672c\u54c1\u8fdb&nbsp;\u884c\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u8bd5\u9a8c\u3002<\/span>&nbsp;<br  style=\"font-family: arial, \u5b8b\u4f53, serif;font-size: 12px;white-space: normal;background-color: rgb(255, 255, 255);\"  \/><br  \/><\/p>\n<p>\u4e8e\u20022017\u2002\u5e74\u20025\u2002\u6708\u83b7\u5f97\u2002FDA\u2002\u7684\u901a\u77e5\uff0c\u516c\u53f8\u5411\u7f8e\u56fd\u2002FDA\u2002\u7533\u62a5\u7684\u5ea6\u6d1b\u897f\u6c40\u80a0&nbsp;<br  style=\"font-family: arial, \u5b8b\u4f53, serif;font-size: 12px;white-space: normal;background-color: rgb(255, 255, 255);\"  \/>\u6eb6\u80f6\u56ca\u65b0\u836f\u7b80\u7565\u7533\u8bf7\uff08ANDA\uff09\u83b7\u5f97\u6279\u51c6\uff1b&nbsp;2017\u2002\u5e74\u200212\u2002\u6708\u200218\u2002\u65e5\uff0c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u53d1\u5e03\u300a\u62df\u7eb3&nbsp;\u5165\u4f18\u5148\u5ba1\u8bc4\u7a0b\u5e8f\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u7684\u516c\u793a\u300b\uff08\u7b2c\u4e8c\u5341\u4e94\u6279\uff09\uff0c\u5c06\u76d0\u9178\u5ea6\u6d1b\u897f\u6c40\u80a0\u6eb6\u80f6\u56ca&nbsp;\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u836f\u54c1\u6ce8\u518c\u7a0b\u5e8f\u5e76\u4e88\u4ee5\u516c\u793a\uff1b\u8fd1\u65e5\uff0c\u516c\u53f8\u6536\u5230\u56fd\u5bb6\u836f\u76d1\u5c40\u6279\u51c6\u5c31\u8be5\u836f&nbsp;\u7269\u8fdb\u884c\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u7684\u4e34\u5e8a\u6279\u4ef6\u3002&nbsp;<span style=\"text-decoration: underline;\">\u534e\u6d77\u8868\u793a\uff1a\u5c06\u4e25\u683c\u6309\u7167\u6279\u4ef6\u8981\u6c42\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\u5411\u56fd\u5bb6\u836f\u76d1\u5c40&nbsp;\u9012\u4ea4\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\u53ca\u76f8\u5173\u6587\u4ef6\uff0c\u540c\u65f6\uff0c\u5b8c\u6210\u2002BE\u2002\u8bd5\u9a8c\u540e\uff0c\u672c\u54c1\u4ecd\u53ef\u4ee5\u901a\u8fc7\u4f18\u5148\u5ba1&nbsp;\u8bc4\u6ce8\u518c\u7a0b\u5e8f\u91cd\u65b0\u7533\u62a5\u751f\u4ea7\u3002&nbsp;<\/span><br  style=\"font-family: arial, \u5b8b\u4f53, serif;font-size: 12px;white-space: normal;background-color: rgb(255, 255, 255);\"  \/>\u2002\u2002<\/p>\n<p><strong>5.<\/strong><span style=\"text-decoration: underline;\">\u53ef\u4ee5\u9884\u89c1\uff0c\u534e\u6d77\u5f88\u5feb\u4f1a\u516c\u544a\u7f2c\u6c99\u5766\u6c22\u6c2f\u567b\u55ea\u7247\u83b7\u6279BE\u3002<\/span><\/p>\n<p><br  \/><\/p>\n<p><strong>6.<\/strong>BE\u4e0d\u7b26\u5408\u8981\u6c42\u4e0d\u9c9c\u89c1\uff0c\u6b64\u524d<span style=\"text-decoration: underline;\">\u77f3\u836f\u96c6\u56e2\u7684\u6c2f\u5421\u683c\u96f7<\/span>\u5c31\u662f\u5982\u6b64\u3002\u5408\u9002\u7684CRO\uff0c\u7b26\u5408ICH,FDA,NMPA\u8981\u6c42\u624d\u662f\u738b\u9053\uff0c\u4e00\u6765\u4e00\u56de\u901f\u5ea6\u53ef\u80fd\u6ca1\u6709\u4e86\u3002<\/p>\n<p><br  \/><\/p>\n<p><strong>7.<\/strong>\u672c\u6587\u4ec5\u4e00\u5bb6\u4e4b\u8a00\uff0c\u4ec5\u4f9b\u53c2\u8003\u3002\u53e6\u5916\u5e0c\u671b\u6211\u56fd\u5236\u5242\u56fd\u9645\u5316\u7684\u534e\u6d77\u836f\u4e1a\u5728\u56fd\u5185\u5e26\u91cf\u91c7\u8d2d\u5f62\u52bf\u4e0b\uff0c\u8d8a\u6765\u8d8a\u597d\uff0c\u4e0d\u80fd\u88ab\u7f8e\u5e1d\u7ed9\u7275\u7eca\u3002<\/p>\n<p><br  \/><\/p>\n<section  label=\"Powered by 135editor.com\" style=\"max-width: 100%;color: rgb(51, 51, 51);letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;border-width: 0px;border-style: none;border-color: initial;word-wrap: break-word !important;\">\n<p><span style=\"font-size: 14px;\">\u53c2\u8003\uff1a<\/span><\/p>\n<p><span style=\"font-size: 14px;\">https:\/\/www.accessdata.fda.gov\/scripts\/cder\/ob\/results_product.cfm?Appl_Type=A&amp;Appl_No=206083\uff1b<\/span><\/p>\n<p><span style=\"font-size: 14px;\">NMPA\/CDE\uff1b<\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u836f\u878d\u6570\u636e\uff0cPharnex &nbsp;Datamonitor;<\/span><\/p>\n<p><span style=\"font-size: 14px;\">FDA\/EMA\uff1b<\/span><\/p>\n<p><span style=\"font-size: 14px;\">\u76f8\u5173\u516c\u53f8\u516c\u5f00\u62ab\u9732\u7b49\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;letter-spacing: 0.544px;box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u6587\u540e\u7559\u8a00\uff0c\u5408\u9002\u7684\u53ef\u6dfb\u52a0Research\u533b\u836f\u4ebaDaniel\u5fae\u4fe1\u3002<\/p>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>1.\u6839\u636e\u836f\u878d\u6570\u636e\uff0cPharnex Datamonitor2018\u5e7411\u670820\u65e5\u76d1\u6d4b\uff1a 2.\u534e\u6d77\u836f\u4e1a\u7f2c\u6c99\u5766\u6c22\u6c2f\u567b [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":60332,"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\/60331"}],"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=60331"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/60331\/revisions"}],"predecessor-version":[{"id":60336,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/60331\/revisions\/60336"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/60332"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=60331"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=60331"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=60331"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}