{"id":1283,"date":"2018-07-05T01:00:00","date_gmt":"2018-07-27T06:27:27","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e3%80%90%e6%94%b6%e8%97%8f%e8%b4%b4%e3%80%91%e7%be%8e%e5%9b%bdanda%e6%b3%a8%e5%86%8c%e5%b8%b8%e8%a7%81%e7%bc%ba%e9%99%b7%e5%88%86%e6%9e%90\/"},"modified":"2018-07-27T14:27:28","modified_gmt":"2018-07-27T06:27:28","slug":"%e3%80%90%e6%94%b6%e8%97%8f%e8%b4%b4%e3%80%91%e7%be%8e%e5%9b%bdanda%e6%b3%a8%e5%86%8c%e5%b8%b8%e8%a7%81%e7%bc%ba%e9%99%b7%e5%88%86%e6%9e%90","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/1283\/","title":{"rendered":"\u3010\u6536\u85cf\u8d34\u3011\u7f8e\u56fdANDA\u6ce8\u518c\u5e38\u89c1\u7f3a\u9677\u5206\u6790"},"content":{"rendered":"
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\"\u3010\u6536\u85cf\u8d34\u3011\u7f8e\u56fdANDA\u6ce8\u518c\u5e38\u89c1\u7f3a\u9677\u5206\u6790\"<\/p>\n

\u672c\u6587\u5185\u5bb9\u6839\u636e\u56fd\u9645\u6ce8\u518c\u8457\u540d\u4e13\u5bb6\u5728<\/span>6<\/span>\u6708\u836f\u7814\u8bba\u575b\u7b2c<\/span>4<\/span>\u671f\u6b27\u7f8e\u4eff\u5236\u836f\u56fd\u9645\u6ce8\u518c\u4e0a\u6240\u4f5c\u62a5\u544a\u6574\u7406\uff1a<\/span>
<\/span><\/p>\n


<\/span><\/p>\n

\u4e00\u3001\u603b\u4f53\u8981\u6c42<\/span><\/strong><\/p>\n

\u4efb\u4e00\u91cd\u5927\u7f3a\u9677<\/span>(Major) <\/span><\/p>\n

\u5fae\u5c0f\u7f3a\u9677<\/span> \uff08<\/span>Minor\uff09\u2267<\/span> 10 <\/span><\/p>\n

\u5fae\u5c0f\u7f3a\u9677<\/span> \u2266<\/span>9 <\/span><\/p>\n

\u88ab\u8981\u6c42\u66f4\u6539\u6216\u8865\u5145\u4fe1\u606f\uff0c\u4f46\u672a\u80fd\u5728<\/span> 7 \uff08\u81ea\u7136\uff09\u5929\u5185\u56de\u590d<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u4e8c\u3001\u91cd\u5927\u7f3a\u9677\uff08\u4efb\u4f55\u4e00\u6761\uff0c\u76f4\u63a5\u62d2\u6536\uff09<\/span><\/strong><\/span><\/p>\n

1.356h \u8868 \/ \u5883\u5916\u7533\u8bf7\u8005\u7f3a\u5931\u7f8e\u56fd\u4ee3\u7406\u4eba<\/span><\/p>\n

2.DMF \u975eCA \u72b6\u6001 \uff08GDUFA Fee\uff0c \u8d77\u59cb\u539f\u6599\u7b49\uff09<\/span><\/p>\n

3.DMF\uff1a\u65e0\u83ccAPI \u7f3a\u5931\u65e0\u83cc\u6570\u636e (second DMF) <\/span><\/p>\n

4.\u7a33\u5b9a\u6027\u6570\u636e\u4e0d\u5168\uff1a\u6279\u6570\u3001\u6279\u91cf\u3001\u4e2d\u95f4\u6761\u4ef6\uff0c\u65f6\u95f4\u6bb5\uff08180-d\uff09\uff0c\u6eb6\u6db2\u5236\u5242\u7684\u7f6e\u653e\u65b9\u5f0f<\/span><\/p>\n

5.\u8f85\u6599\uff1a\u4efb\u4f55\u8f85\u6599\u6216\u590d\u5408\u8f85\u6599\u7ec4\u5206\u8d85\u51faFDA IID \u4e0a\u9650\uff08\u65e0\u5408\u7406\u4f9d\u636e\uff09<\/span><\/p>\n

6.\u5236\u5242\u4e2d\u94c1\u542b\u91cf > 5 mg\/day <\/span><\/p>\n

7.\u523b\u75d5\u72b6\u6001\u4e0e RLD \u4e0d\u7b26<\/span><\/p>\n

8.\u6eb6\u51fa\u6570\u636e\u4e0d\u5168 \uff08\u9152\u7cbe\u8bd5\u9a8c\u3001\u523b\u75d5\u7247\u5242\u7684\u534a\u7247\u6eb6\u51fa\u3001BE\u6307\u5357\u7279\u5b9a\u6eb6\u51fa\uff09<\/span><\/p>\n

9.\u5236\u5242\u914d\u65b9Q\/Q\uff08\u9488\u5242\uff0c\u6ef4\u773c\u5242\u7b49\uff09\u3001FillVolume\uff0c \u65e0\u83cc\u9a8c\u8bc1<\/span><\/p>\n

10.\u516c\u6c11\u8bf7\u613f\u672a\u4e86 \uff08Pending Suitability Petition\uff09<\/span><\/p>\n

11.BE \uff08Tables\uff0c Forms\uff09<\/span><\/p>\n


<\/span><\/strong><\/span><\/p>\n

\u4e09\u3001\u5176\u4ed6\u7f3a\u9677<\/span><\/strong><\/span><\/p>\n

1.\u6742\u8d28\u5bf9\u7167\u54c1\u4fe1\u606f\u4e0d\u5168\uff08<\/span>IR\u3001<\/span>MNR\uff0c<\/span>MS\uff0c<\/span> UV\u56fe\u8c31\uff0c<\/span>CoA\u2026<\/span>) <\/span><\/p>\n

2.\u7a33\u5b9a\u6027\u6570\u636e\u8d8b\u52bf\u5206\u6790\uff0c<\/span> \u52a0\u901f\u5931\u8d25\u540e\u7684\u4e2d\u95f4\u6761\u4ef6\u6570\u636e<\/span><\/span><\/p>\n

3.\u7a33\u5b9a\u6027\u5b9e\u9a8c\u65b9\u6848\u548c\u6570\u636e\uff08\u653e\u6837<\/span>\/\u53d6\u6837\u65f6\u95f4\u2026\uff0c\u8bd5\u9a8c\u5730\u70b9<\/span>) <\/span><\/p>\n

4.\u7814\u53d1\u62a5\u544a<\/span>\/QOS \u4e0e<\/span>M3\u5185\u5bb9\u524d\u540e\u77db\u76fe\uff08\u91cd\u590d\u5185\u5bb9\uff09<\/span><\/span><\/p>\n

5.\u5305\u6750<\/span> \uff08<\/span>water permeation, light transmission\uff09<\/span><\/span><\/p>\n

6.\u89c4\u5b9a\u7684\u8868\u683c\uff1a\u4e0d\u505a\u4efb\u4f55\u8c03\u6574\uff0c\u4fdd\u6301\u539f\u6837<\/span><\/p>\n

7.\u751f\u4ea7\u6279\u8bb0\u5f55\uff08\u4f8b\uff1a\u7269\u6599\u5e73\u8861\u8868\u8bf7\u7528<\/span>Tablet \u8ba1\uff0c\u800c\u4e0d\u662f<\/span>Kg \u8ba1\uff09<\/span><\/span><\/p>\n

8.\u6ca1\u6709\u8be6\u7ec6\u7684\u751f\u4ea7\u63cf\u8ff0\uff08\u9664\u6279\u8bb0\u5f55\u5916\uff09<\/span><\/p>\n

9.\u6279\u8bb0\u5f55\u751f\u4ea7\u8fc7\u7a0b\u63a7\u5236\u4e0d\u8db3\uff08\u4e0e\u7814\u53d1\u62a5\u544a\u6302\u94a9\uff09<\/span><\/p>\n

10.cGMP\u8bc1\u4e66<\/span> \uff08\u7f3a\u5931\u6216\u63aa\u8f9e\u95ee\u9898\uff09<\/span><\/span><\/p>\n

11.\u751f\u4ea7\u573a\u5730\u63cf\u8ff0<\/span>(API\u548c\u5236\u5242\u7684\u751f\u4ea7\u3001\u68c0\u6d4b\u3001\u5305\u88c5\u573a\u5730\u2026\u7b49\uff09<\/span><\/span><\/p>\n

12.\u6eb6\u51fa\u66f2\u7ebf\u6bd4\u8f83<\/span> <\/span><\/p>\n

Test BE strength vs. RLD<\/span><\/p>\n

Test other strength vs. RLD and Reference (strength)<\/span><\/p>\n

Test other strength vs.BE strength (f2)<\/span><\/p>\n

Summary and raw data (<\/span>\u5305\u62ec\u8bd5\u9a8c\u6761\u4ef6\u548c\u5730\u70b9\u3001\u8bd5\u9a8c\u65f6\u95f4\u3001\u6837\u54c1\u5b58\u4fdd\u5b58\u6761\u4ef6\uff09<\/span><\/p>\n

\u5176\u4ed6\u5a92\u4ecb\u6216\u6761\u4ef6\uff08\u63a7\u91ca\u5236\u5242\uff09\u2026<\/span><\/p>\n

 <\/span><\/p>\n

\u56db\u3001<\/span><\/strong>ANDA<\/span><\/strong>\u6210\u529f\u5feb\u901f\u83b7\u6279\u7684\u5173\u952e<\/span><\/strong><\/span><\/p>\n

1.Secret to success: high submission quality!<\/span><\/p>\n

Good Product \uff08\u7814\u53d1\u3001\u751f\u4ea7\u548c\u68c0\u9a8c\uff09<\/span>+ Good Submission \uff08\u6587\u4ef6\u7f16\u5199\uff09<\/span><\/span><\/p>\n

DMF \u5728<\/span>CA \u72b6\u6001\uff0c<\/span> \u73b0\u573a\u68c0\u67e5<\/span> Ready<\/span> <\/span><\/p>\n

2.Concise, specific and necessary info <\/span><\/p>\n

\u4fe1\u606f\u63d0\u4f9b\uff1a\u7b80\u660e\uff0c\u5177\u4f53\u548c\u5fc5\u8981<\/span> <\/span><\/p>\n

3.Charts and tables preferred <\/span><\/p>\n

\u5c3d\u53ef\u80fd\u7528\u8868\u683c\u548c\u56fe\u793a<\/span> <\/span><\/p>\n

4.Justified, justified, justified\u2026<\/span><\/span><\/p>\n

\u660e\u786e\u7684\u79d1\u5b66\u8fa9\u89e3<\/span> <\/span><\/p>\n

5.Risk- and science-based thinking andwriting <\/span><\/p>\n

\u98ce\u9669\u5206\u6790\u548c\u79d1\u5b66\u4e3a\u57fa\u7840\u7684\u601d\u8003\u548c\u5199\u4f5c<\/span> <\/span><\/p>\n

6.Provide complete and timely responses <\/span><\/p>\n

\u63d0\u4f9b\u5b8c\u6574\u548c\u53ca\u65f6\u7684\u7b54\u590d<\/span> <\/p>\n


<\/span><\/p>\n

—THE END—<\/span><\/p>\n

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\u836f\u7814\u8bba\u575b\u7b2c5\u671f\u4f1a\u8bae\u4ecb\u7ecd\uff1a<\/span>2018\u6ce8\u5c04\u5242\u4e00\u81f4\u6027\u8bc4\u4ef7\u5173\u952e\u6280\u672f\u4e0e\u653f\u7b56\u6cd5\u89c4<\/span><\/a><\/p>\n


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\u58f0\u660e\uff1a\u836f\u7814\u5bf9\u672c\u6587\u9648\u8ff0\u548c\u89c2\u70b9\u4fdd\u6301\u4e2d\u7acb\uff0c\u4e0d\u5bf9\u6587\u7ae0\u5185\u5bb9\u53ef\u9760\u6027\u63d0\u4f9b\u4efb\u4f55\u4fdd\u8bc1\u3002\u4ec5\u4f9b\u53c2\u8003\uff01\u672c\u6587\u4ec5\u4e3a\u5b66\u4e60\u4ea4\u6d41\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\uff0c\u5982\u9047\u7248\u6743\u95ee\u9898\u8bf7\u8054\u7cfb\u6211\u4eec\u5220\u9664\uff0c\u8c22\u8c22\uff01<\/span><\/p>\n


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\u5173\u6ce8\u836f\u7814  \u4e00\u8def\u540c\u884c<\/span><\/p>\n

\u57f9\u8bad\uff5c\u6295\u7a3f\uff5c\u5408\u4f5c<\/span><\/p>\n

V:diaodiao666666<\/span><\/p>\n<\/section>\n

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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u7814 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u672c\u6587\u5185\u5bb9\u6839\u636e\u56fd\u9645\u6ce8\u518c\u8457\u540d\u4e13\u5bb6\u57286\u6708\u836f\u7814\u8bba\u575b\u7b2c4\u671f\u6b27\u7f8e\u4eff\u5236\u836f\u56fd\u9645\u6ce8\u518c\u4e0a\u6240\u4f5c\u62a5\u544a\u6574\u7406\uff1a \u4e00\u3001\u603b\u4f53\u8981\u6c42 \u4efb\u4e00\u91cd\u5927\u7f3a\u9677 […]<\/p>\n","protected":false},"author":1,"featured_media":1284,"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\/1283"}],"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=1283"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/1283\/revisions"}],"predecessor-version":[{"id":1286,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/1283\/revisions\/1286"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/1284"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=1283"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=1283"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=1283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}