{"id":61499,"date":"2018-11-16T01:00:00","date_gmt":"2018-12-07T03:08:15","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/3de39bf704\/"},"modified":"2018-12-07T11:08:16","modified_gmt":"2018-12-07T03:08:16","slug":"3de39bf704","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/61499\/","title":{"rendered":"DMF\u7f3a\u9677\u53ef\u80fd\u5371\u53ca\u4eff\u5236\u836f\u7533\u8bf7\u7684\u53ca\u65f6\u6279\u51c6"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"text-align: center;\"><span style=\"font-size: 15px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);text-align: left;widows: 1;\"><\/span><\/p>\n<p><span style=\"font-size: 15px;\"><\/span><\/p>\n<p style=\"text-align: center;\"><img class=\"\"      style=\"\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/3-1544152096.gif\" alt=\"DMF\u7f3a\u9677\u53ef\u80fd\u5371\u53ca\u4eff\u5236\u836f\u7533\u8bf7\u7684\u53ca\u65f6\u6279\u51c6\" title=\"DMF\u7f3a\u9677\u53ef\u80fd\u5371\u53ca\u4eff\u5236\u836f\u7533\u8bf7\u7684\u53ca\u65f6\u6279\u51c6\"  \/><\/p>\n<p><br  \/><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u539f\u6599\u5236\u9020\u5546\u9700\u8981\u9762\u5bf9\u63d0\u4ea4\u66f4\u9ad8\u8d28\u91cf II \u578b DMF \u7684\u538b\u529b\u3002\u7f8e\u56fd FDA \u5b98\u5458\u8868\u793a\uff0c\u8bb8\u591a ANDA \u7684\u6279\u51c6\u56e0\u4f4e\u8d28\u91cf DMF \u800c\u5ef6\u8fdf\u3002\u800c\u4eff\u5236\u836f\u4f01\u4e1a\u4ee3\u8868\u5219\u8ba4\u4e3a\uff0c\u8fd9\u4e00\u95ee\u9898\u90e8\u5206\u5e94\u5f52\u548e\u4e8e FDA \u5bf9 DMF \u65bd\u52a0\u7684\u4e0d\u5207\u5b9e\u9645\u7684\u76d1\u7ba1\u671f\u671b\u548c\u4e0d\u73b0\u5b9e\u7684\u9ad8\u6807\u51c6\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7f8e\u56fd FDA \u836f\u54c1\u5ba1\u8bc4\u4e0e\u7814\u7a76\u4e2d\u5fc3\uff08CDER\uff09\u836f\u54c1\u8d28\u91cf\u529e\u516c\u5ba4\uff08OPQ\uff09\u5316\u5b66\u5bb6 Ramnarayan Randad \u5728 5 \u6708 24 \u65e5\u7684\u666e\u4eab\u836f\u534f\u4f1a\uff08AAM\uff09CMC \u7814\u8ba8\u4f1a\u4e0a\u8868\u793a\uff0c\u539f\u6599\u836f\u5236\u9020\u5546\u5e94\u63d0\u9ad8\u5176 II \u578b\u836f\u7269\u4e3b\u6587\u4ef6\uff08DMF\uff09\u63d0\u4ea4\u7684\u8d28\u91cf\u4ee5\u52a0\u5feb DMF \u548c\u5f15\u7528\u76f8\u5e94 DMF \u7684\u4eff\u5236\u836f\u7533\u8bf7\u7684\u6279\u51c6\u3002Randad \u6307\u51fa DMF \u63d0\u4ea4\u8d28\u91cf\u4ecd\u5b58\u5728\u5f88\u591a\u63d0\u5347\u7a7a\u95f4\uff1a<span style=\"max-width: 100%;color: rgb(204, 102, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">98% \u7684 DMF \u5728\u9996\u8f6e\u5ba1\u8bc4\u4e2d\u88ab\u62d2\u7edd\uff0c\u5e76\u4e14 DMF \u7684\u591a\u8f6e\u5ba1\u8bc4\u72b6\u6001\u6b63\u5728\u963b\u788d\u8fd1\u4e09\u5206\u4e4b\u4e00\u7684\u4eff\u5236\u836f\u7533\u8bf7\u5728\u9996\u8f6e\u5ba1\u8bc4\u4e2d\u83b7\u5f97\u6279\u51c6<\/span>\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Randad \u5728\u4f1a\u4e0a\u63d0\u4f9b\u4e86\u6709\u5173\u5982\u4f55\u6539\u5584\u63d0\u4ea4\u8d28\u91cf\u7684\u6280\u5de7\uff0c\u4ee5\u4fbf\u66f4\u591a DMF \u548c ANDA \u5f97\u5230\u53ca\u65f6\u6279\u51c6\u3002\u4f9d\u636e\u300a2012 \u4eff\u5236\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u4fee\u6b63\u6848\u300b\uff08GDUFA\uff09\uff0cFDA \u5728\u786e\u5b9a\u76f8\u5173 DMF \u662f\u201c\u53ef\u4f9b\u5f15\u7528\u201d\u7684\u4e4b\u524d\u4e0d\u80fd\u5f00\u59cb ANDA \u5ba1\u8bc4\u3002Randad \u8868\u793a\uff0c\u201c\u597d\u6d88\u606f\u662f\uff0c2% \u7684 DMF \u5728\u9996\u8f6e\u83b7\u6279\u3002\u6211\u4eec\u8fd8\u6709\u5f88\u957f\u7684\u8def\u8981\u8d70\uff0c\u4e5f\u8bb8\u5230\u660e\u5e74\u6211\u518d\u6b21\u7ad9\u5728\u8fd9\u91cc\u6f14\u8bb2\u7684\u65f6\u5019\u4f1a\u8bf4\u8fd9\u4e00\u6570\u636e\u53d8\u5f97\u66f4\u597d\u4e86\u3002\u53e6\u4e00\u597d\u6d88\u606f\u662f\uff0c<span style=\"max-width: 100%;color: rgb(204, 102, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u6709 50% \u7684 ANDA \u5f15\u7528\u7684\u662f\u5df2\u83b7\u6279\u53ef\u4f9b\u5f15\u7528\u7684 DMF<\/span>\u3002\u201d<\/span><\/p>\n<p style=\"padding: 8px 12px;max-width: 100%;border-left-width: 4px;border-left-color: rgb(85, 142, 213);letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);quotes: none;font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;color: rgb(85, 142, 213);height: auto;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">DMF \u5ba1\u8bc4\u65f6\u95f4\u8fc7\u957f\u5bfc\u81f4 ANDA \u6279\u51c6\u5ef6\u8fdf<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">FDA \u5206\u6790 2015 \u5e74 1 \u6708\u5230 2016 \u5e74 6 \u6708\u63d0\u4ea4\u7684 521 \u4ef6 DMF \u53d1\u73b0\uff0c\u5e73\u5747\u54cd\u5e94\u65f6\u95f4\u4e3a 161 \u5929\uff0c\u7ea6 5.5 \u4e2a\u6708\uff0c\u4e2d\u4f4d\u54cd\u5e94\u65f6\u95f4\u4e3a 133 \u5929\uff0c\u8d85\u8fc7 4 \u4e2a\u6708\u3002\u6279\u51c6 DMF \u7684\u6700\u77ed\u65f6\u95f4\u4e3a 11\u5929\uff0c\u6700\u957f\u4e3a 667 \u5929\u3002\u5206\u6790\u663e\u793a\uff0c98% \u7684 DMF \u5728\u9996\u8f6e\u5ba1\u8bc4\u4e2d\u88ab\u62d2\u7edd\u5e76\u53d1\u5e03\u5b8c\u5168\u56de\u5e94\u51fd\uff0c\u5927\u90e8\u5206 DMF \u5728\u83b7\u6279\u4e4b\u524d\u9700\u8981\u63a5\u53d7\u4e24\u8f6e\u6216\u4e09\u8f6e\u5ba1\u8bc4\u3002\u6570\u636e\u8fdb\u4e00\u6b65\u663e\u793a\uff0c\u5927\u591a\u6570 DMF\uff0868%\uff09\u5728 91 \u5929\u6216\u66f4\u957f\u65f6\u95f4\u5185\u83b7\u5f97\u5ba1\u6279\u51b3\u5b9a\uff0c\u800c\u5f88\u5c11\u4e00\u90e8\u5206 DMF \u5728\u66f4\u77ed\u7684\u65f6\u95f4\u5185\u83b7\u5f97\u5ba1\u8bc4\u51b3\u5b9a\uff1b17% \u7684DMF \u5728 60 \u5929\u6216\u66f4\u77ed\u65f6\u95f4\u5185\u83b7\u5f97\u5ba1\u6279\u51b3\u5b9a\uff0c15% \u7684 DMF \u5728 61 \u523090\u5929\u5185\u83b7\u5f97\u5ba1\u8bc4\u51b3\u5b9a\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8c03\u67e5\u7ed3\u679c\u663e\u793a\uff0c<span style=\"max-width: 100%;color: rgb(204, 102, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u51cf\u5c11 DMF \u7684\u5ba1\u8bc4\u8f6e\u6b21\u6570\u548c DMF \u6301\u6709\u4eba\u7684\u54cd\u5e94\u65f6\u95f4\u5bf9\u4e8e\u589e\u52a0 ANDA \u9996\u8f6e\u6279\u51c6\u7684\u673a\u4f1a\u662f\u81f3\u5173\u91cd\u8981\u7684<\/span>\u3002Randad \u8868\u793a\uff0c\u201c\u9996\u8f6e\u54cd\u5e94\u65f6\u95f4\u592a\u957f\uff0c\u8fd9\u4e0e\u9996\u8f6e ANDA \u6279\u51c6\u7684 10 \u4e2a\u6708\u6216 8 \u4e2a\u6708\u5ba1\u8bc4\u65f6\u949f\u4e0d\u5339\u914d\u3002\u6839\u636e\u6211\u4eec\u7684\u5206\u6790\uff0c\u9664\u975e DMF \u54cd\u5e94\u65f6\u95f4\u660e\u663e\u51cf\u5c11\uff0c\u5426\u5219\u6700\u591a\u53ef\u80fd\u6709\u4e09\u5206\u4e4b\u4e00\u7684\u539f\u59cb ANDA \u53ef\u80fd\u56e0\u6240\u5f15\u7528\u7684 DMF \u95ee\u9898\u800c\u4e0d\u7b26\u5408\u9996\u8f6e\u6279\u51c6\u6761\u4ef6\u3002\u201d<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4e3a\u4e86\u7f29\u77ed\u8fd9\u4e9b\u65f6\u95f4\u8868\uff0c\u4ed6\u8868\u793a\uff0c\u201c\u4f01\u4e1a\u548c FDA \u5e94\u5171\u540c\u52aa\u529b\u964d\u4f4e\u62d2\u6536\u7387\u3002\u56e0\u6b64\uff0c\u7533\u8bf7\u4eba\u5e94\u4e0e\u81ea\u5df1\u7684 DMF \u6301\u6709\u4eba\u660e\u786e\u6c9f\u901a ANDA \u884c\u52a8\u65f6\u95f4\u8868\uff0c\u5e76\u6709\u6548\u5730\u5229\u7528\u7535\u8bdd\u4f1a\u8bae\u548c\u7535\u5b50\u90ae\u4ef6\u5bf9\u7f3a\u9677\u505a\u51fa\u6f84\u6e05\u4ece\u800c\u4f7f\u56de\u590d\u5b8c\u6574\u3002\u201dRandad \u8fd8\u5efa\u8bae<span style=\"max-width: 100%;color: rgb(204, 102, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">&nbsp;DMF \u6301\u6709\u4eba\u5e94\u907f\u514d\u5bf9\u5df2\u63d0\u4ea4\u7684 DMF \u63d0\u4ea4\u589e\u8865<\/span>\u3002\u672a\u7ecf\u8981\u6c42\u7684\u589e\u8865\u53ef\u80fd\u4f1a\u5ef6\u8fdf ANDA \u6279\u51c6\u3002<\/span><\/p>\n<p style=\"padding: 8px 12px;max-width: 100%;border-left-width: 4px;border-left-color: rgb(85, 142, 213);letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);quotes: none;font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;color: rgb(85, 142, 213);height: auto;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">DMF \u7f3a\u9677\u6982\u89c8<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Randad \u8ba8\u8bba\u4e86\u6700\u8fd1\u63d0\u4ea4\u7684 DMF \u4e2d\u963b\u788d\u9996\u8f6e\u6279\u51c6\u7684\u4e00\u4e9b\u4e3b\u8981\u7f3a\u9677\u3002\u8fd9\u4e9b\u63d0\u4ea4\u4fe1\u606f\u6309\u7167\u901a\u7528\u6280\u672f\u6587\u4ef6\uff08CTD\uff09\u6a21\u5757\u4e09 \u539f\u6599\u836f\u8d28\u91cf\u90e8\u5206\u7684\u7ae0\u8282\u5f52\u7c7b\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">CTD S.2 \u90e8\u5206\u53d1\u73b0\u7684\u4e00\u4e9b\u95ee\u9898\u6709\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u672a\u62a5\u544a\u201c\u9690\u85cf\u8bbe\u65bd\u201d\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5982\u679c\u8bbe\u65bd\u9700\u8981\u63a5\u53d7\u68c0\u67e5\uff0c\u8fd9\u53ef\u80fd\u9700\u8981\u76f8\u5f53\u957f\u7684\u65f6\u95f4\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5916\u5305\u5236\u9020\u5de5\u827a\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7f3a\u5c11\u5173\u4e8e\u5916\u5305\u5de5\u827a\u7684\u4fe1\u606f\u53ef\u80fd\u4f1a\u4ea7\u751f\u591a\u4e2a\u7f3a\u9677\u3002\u8fd9\u4e5f\u589e\u52a0\u4e86\u8bbe\u65bd\u53ef\u80fd\u9700\u8981\u63a5\u53d7\u68c0\u67e5\u7684\u98ce\u9669\uff0c\u8fd9\u53ef\u80fd\u9700\u8981\u76f8\u5f53\u957f\u7684\u65f6\u95f4\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u62e5\u6709\u591a\u4e2a\u4e2d\u95f4\u7269\u6599\u4f9b\u5e94\u5546\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u62a5\u544a\u591a\u4e2a\u4e2d\u95f4\u4f9b\u5e94\u5546\uff0c\u5982\u679c\u6ca1\u6709\u63d0\u4f9b\u8db3\u591f\u7684\u6570\u636e\u8bc1\u660e\u7269\u6599\u5177\u6709\u76f8\u540c\u7684\u8d28\u91cf\uff0c\u6216\u8005\u5982\u679c\u4f9b\u5e94\u5546\u5236\u9020\u5de5\u827a\u4e4b\u95f4\u5b58\u5728\u663e\u8457\u5dee\u5f02\uff0c\u53ef\u80fd\u4f1a\u5bfc\u81f4\u7f3a\u9677\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7533\u62a5\u4e0d\u53ef\u63a5\u53d7\u7684 API \u8d77\u59cb\u7269\u6599\uff0c\u5e76\u4e14\u6ca1\u6709\u5fc5\u8981\u7684\u8bba\u8bc1\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8fd9\u53ef\u80fd\u5bfc\u81f4\u8981\u6c42\u5728\u5236\u9020\u5de5\u827a\u4e2d\u66f4\u65e9\u7684\u5efa\u7acb\u8d77\u59cb\u7269\u6599\uff0cRandad \u79f0\u4e4b\u4e3a\u201c\u5927\u91cf\u5de5\u4f5c\u201d\u3002\u4ed6\u8868\u793a\uff0c\u201c\u5982\u679c\u6ca1\u6709\u8ba8\u8bba\u8d77\u59cb\u7269\u6599\u7684\u8bdd\uff0c\u4f1a\u8bae\u4e0a\u7684\u4efb\u4f55\u8ba8\u8bba\u90fd\u662f\u4e0d\u5b8c\u6574\u7684\u3002\u660e\u667a\u5730\u4f7f\u7528\u8d77\u59cb\u7269\u6599\u5e76\u4f5c\u51fa\u8bba\u8bc1\u3002\u6211\u53ef\u4ee5\u7ed9\u4f60\u4eec\u7684\u6700\u4f73\u6307\u9488\u5c31\u662f\u4f7f\u7528 ICH Q 11 \u4e2d\u5217\u51fa\u7684\u6807\u51c6\uff0c\u5e76\u4e14\u4e0d\u8981\u9009\u62e9\u6027\u7684\u4f7f\u7528\u3002\u201d\u4ed6\u8fd8\u4ecb\u7ecd\u4e86\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u4e8e 2014 \u5e74 9 \u6708\u53d1\u5e03\u7684\u6709\u5173\u8bba\u8bc1\u8d77\u59cb\u7269\u6599\u7684\u610f\u89c1\u4e66\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5bf9\u6742\u8d28\u548c\u4e2d\u95f4\u4f53\u89c4\u683c\u8bbe\u7f6e\u6700\u5927\u4e0a\u9650\uff0c\u5e76\u4e14\u89c4\u683c\u592a\u5bbd\u6cdb\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8fd9\u53ef\u80fd\u5bfc\u81f4\u8981\u6c42\u5bf9\u539f\u6599\u836f\u89c4\u683c\u4e2d\u672a\u68c0\u6d4b\u7684\u6742\u8d28\u5f00\u5c55\u52a0\u6837\/\u6e05\u9664\u7814\u7a76\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5728\u8ba8\u8bba\u6b8b\u7559\u4e2d\u95f4\u4f53\u7684\u53bb\u5411\u65f6\u6ca1\u6709\u8003\u8651\u526f\u4ea7\u7269\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Randad \u8868\u793a\uff0c\u8fd9\u4e9b\u7269\u6599\u53bb\u5411\u7684\u8ba8\u8bba\u5e94\u5305\u62ec\u53ef\u80fd\u7531\u4e8e\u4e0b\u6e38\u6301\u7eed\u53cd\u5e94\u800c\u5f62\u6210\u7684\u526f\u4ea7\u7269\u7684\u6570\u636e\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u6ca1\u6709\u89e3\u51b3\u8d77\u59cb\u7269\u6599\u4e2d\u7684\u4f4d\u7f6e\u5f02\u6784\u4f53\u3001\u7acb\u4f53\u5f02\u6784\u4f53\u4ee5\u53ca\u957f\u94fe\u548c\u77ed\u94fe\u7c7b\u4f3c\u7269\u7b49\u6742\u8d28\u95ee\u9898\u3002\u8fd9\u53ef\u80fd\u4f1a\u5bfc\u81f4\u8981\u6c42\u8fd9\u4e9b\u6570\u636e\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">CTD S.3 \u90e8\u5206\u53d1\u73b0\u7684\u4e00\u4e9b\u95ee\u9898\u6709\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8bbe\u5b9a\u7684\u9650\u5ea6\u8d85\u8fc7 ICH Q3A \u7684\u6742\u8d28\u9650\u5ea6\u800c\u6ca1\u6709\u5145\u5206\u8bba\u8bc1\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Randad \u8868\u793a\uff0c\u8d85\u51fa\u8fd9\u4e9b\u9650\u5ea6\u7684\u6742\u8d28\u5b89\u5168\u6027\u7814\u7a76\u5c06\u9700\u8981\u53ef\u80fd\u82b1\u8d39\u5927\u91cf\u65f6\u95f4\u7684\u836f\u7406\/\u6bd2\u7406\u54a8\u8be2\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u63d0\u4ea4\u7684\u4e0e\u53c2\u7167\u836f\u54c1\u7684\u5bf9\u6bd4\u6570\u636e\u4ec5\u4f7f\u7528\u4fdd\u7559\u65f6\u95f4\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8fd9\u53ef\u80fd\u5bfc\u81f4\u8981\u6c42\u63d0\u4f9b\u8fdb\u4e00\u6b65\u6570\u636e\uff0c\u56e0\u4e3a\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u4e0d\u662f\u7279\u5b9a\u7684\u9274\u522b\u68c0\u6d4b\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">CTD S.4 \u90e8\u5206\u53d1\u73b0\u7684\u4e00\u4e9b\u95ee\u9898\u6709\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5f53\u4f7f\u7528\u5185\u90e8\u65b9\u6cd5\u65f6\uff0c\u6ca1\u6709\u5bf9 USP \u6742\u8d28\u63d0\u4ea4\u5b8c\u6574\u7684\u65b9\u6cd5\u9a8c\u8bc1\u4fe1\u606f\u3002<\/span><\/strong><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u63d0\u4ea4\u7684\u5206\u6790\u65b9\u6cd5\u7f3a\u4e4f\u9488\u5bf9\u9884\u671f\u76ee\u7684\u6240\u9700\u7684\u7075\u654f\u5ea6\u3002<\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">CTD S.7 \u90e8\u5206\u53d1\u73b0\u7684\u4e00\u4e9b\u7f3a\u9677\u4e3e\u4f8b\u6709\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5f3a\u5236\u964d\u89e3\u7814\u7a76\u4e2d\u7f3a\u4e4f\u8d28\u91cf\u5e73\u8861\u3002<\/span><\/strong><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8fd9\u5f15\u53d1\u4e86\u5206\u6790\u65b9\u6cd5\u662f\u5426\u7a33\u5b9a\u6307\u793a\u7684\u95ee\u9898\uff0c\u53ef\u80fd\u5bfc\u81f4\u8981\u6c42\u91cd\u505a\u7814\u7a76\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7a33\u5b9a\u6027\u7814\u7a76\u4e2d\u5b58\u5728\u8d85\u6807\u7ed3\u679c\u800c\u6ca1\u6709\u67e5\u660e\u6839\u672c\u539f\u56e0\u3002<\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n<p style=\"padding: 8px 12px;max-width: 100%;border-left-width: 4px;border-left-color: rgb(85, 142, 213);letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);quotes: none;font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;color: rgb(85, 142, 213);height: auto;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4f01\u4e1a\u8ba4\u4e3a FDA \u5e94\u4e3a DMF \u5ba1\u6279\u5ef6\u8bef\u4ed8\u90e8\u5206\u8d23\u4efb<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">Mylan \u5236\u53d1\u8d1f\u8d23\u4eba Dan Snider \u8868\u793a\uff0c\u4f01\u4e1a\u5bf9\u4e8e FDA \u5982\u4f55\u5904\u7406\u548c\u5ba1\u67e5 DMF \u5b58\u5728\u4e00\u4e9b\u7591\u95ee\u3002\u4ed6\u7684\u6f14\u8bb2\u662f\u57fa\u4e8e\u5bf9 AAM \u6210\u5458\u516c\u53f8\u7684\u8c03\u67e5\u4ee5\u53ca\u4ed6\u4eec\u5728\u63d0\u4ea4 DMF \u4e2d\u4e0e FDA \u6253\u4ea4\u9053\u7684\u7ecf\u9a8c\u3002\u4e89\u8bba\u7684\u4e00\u4e2a\u65b9\u9762\u662f\uff0c<span style=\"max-width: 100%;color: rgb(204, 102, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">FDA \u5ba1\u8bc4\u4eba\u5458\u65bd\u52a0\u4e86\u6bd4 ICH \u548c USP \u6742\u8d28\u6807\u51c6\u66f4\u4e25\u683c\u7684\u6742\u8d28\u9608\u503c<\/span>\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-align: justify;white-space: normal;background-color: rgb(255, 255, 255);line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4e00\u4e9b\u4f8b\u5b50\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;margin-top: 10px;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 15px;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5728\u4e00\u4e2a\u4e0e\u7b2c\u4e09\u65b9 API \u4f9b\u5e94\u5546\u6709\u5173\u7684\u591a\u4ef6 ANDA \u51fa\u73b0\u5ef6\u8fdf\u7684\u4f8b\u5b50\u4e2d\uff0cOPQ \u8981\u6c42 DMF \u6301\u6709\u4eba\u786e\u8ba4\u7ec8\u4ea7\u54c1\u4e2d\u4e0d\u5b58\u5728\u201c\u4e00\u4e2a\u6216\u591a\u4e2a\u7406\u8bba\u5de5\u827a\u6742\u8d28\u201d\u3002OPQ \u8981\u6c42 DMF 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