{"id":9,"date":"2025-02-13T23:23:01","date_gmt":"2025-02-13T23:23:01","guid":{"rendered":"https:\/\/isosolution-v2.staging.xiyx.ai\/news\/health-canada-drug-master-file-dmf-submission\/"},"modified":"2026-08-19T20:22:14","modified_gmt":"2026-08-19T20:22:14","slug":"health-canada-drug-master-file-dmf-submission","status":"publish","type":"iso_news","link":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/news\/health-canada-drug-master-file-dmf-submission\/","title":{"rendered":"\u52a0\u62ff\u5927\u536b\u751f\u90e8\u836f\u7269\u603b\u6863\u6848(DMF)\u6750\u6599"},"content":{"rendered":"
\n
\n

\u5f17\u6717\u7d22\u74e6,\u4e0d\u5217\u98a0 \u54e5\u4f26\u5e03,\u52a0\u62ff\u5927, <\/p>\n

2024\u5e742\u670810\u65e5 (\u82f1\u8bed)<\/cite><\/p><\/blockquote>\n<\/figure>\n

\u5357\u975e\u5f00\u666e\u6566\u548c\u52a0\u62ff\u5927\u6e29\u54e5\u534e-iThemba LABS\u4e0eisoSolutions\u5408\u4f5c,\u81ea\u8c6a\u5730\u5ba3\u5e03\u6210\u529f\u63d0\u4ea4iThembaLABS\u836f\u7269\u603b\u6587\u4ef6(DMF)  68Ge\/68Ga \u53d1\u7535\u673a<\/a> \u52a0\u62ff\u5927\u536b\u751f\u90e8\u3002 \u8fd9\u4e00\u91cd\u5927\u91cc\u7a0b\u7891\u6807\u5fd7\u7740\u533b\u5b66\u6210\u50cf\u9886\u57df\u7684\u4e00\u9879\u91cd\u5927\u8fdb\u6b65,\u7279\u522b\u662f\u5728\u6b63\u7535\u5b50\u6392\u653e\u6210\u50cf\u65b9\u9762,\u5e76\u8868\u660e\u4e24\u5bb6\u516c\u53f8\u81f4\u529b\u4e8e\u63d0\u9ad8\u52a0\u62ff\u5927\u5168\u56fd\u7684\u8bca\u65ad\u80fd\u529b.
NRF \u2013 iThemba LABS\u7684\u4ea7\u7269,68Ge\/68Ga\u751f\u6210\u5668\u88ab\u8bbe\u8ba1\u51fa\u6765,\u4ee5\u63d0\u4f9b\u53ef\u9760\u800c\u9ad8\u6548\u7684Gallium-68\u6e90,\u4e00\u79cd\u5e7f\u6cdb\u7528\u4e8e\u80bf\u7624\u5b66,\u5fc3\u810f\u75c5\u5b66\u548c\u795e\u7ecf\u6210\u50cf\u5b66\u5e94\u7528\u7684\u653e\u5c04\u7ba1. \u901a\u8fc7\u4fc3\u8fdbGa-68\u7684\u73b0\u573a\u751f\u4ea7,\u53d1\u7535\u673a\u65e8\u5728\u6539\u8fdb\u5173\u952e\u6210\u50cf\u6280\u672f\u7684\u53ef\u83b7\u53d6\u6027,\u540c\u65f6\u7b80\u5316\u4e34\u5e8a\u73af\u5883\u4e2d\u7684\u5de5\u4f5c\u6d41\u7a0b.
\u4f5c\u4e3a\u5236\u4f5c\u4eba,iThemba LABS\u5c06\u5927\u91cf\u8d44\u6e90\u7528\u4e8eGa-68\u53d1\u7535\u673a\u7684\u7814\u53d1,\u786e\u4fdd\u5b83\u8fbe\u5230\u6700\u9ad8\u7684\u8d28\u91cf\u6807\u51c6\u548c\u76d1\u7ba1\u5408\u89c4\u6807\u51c6. \u4f5c\u4e3a\u7ecf\u9500\u5546,isoSolutions\u81f4\u529b\u4e8e\u4e3a\u52a0\u62ff\u5927\u5404\u5730\u7684\u4fdd\u5065\u63d0\u4f9b\u8005\u5e26\u6765\u521b\u65b0\u7684\u533b\u7597\u6210\u50cf\u89e3\u51b3\u65b9\u6848,\u901a\u8fc7\u6539\u5584\u83b7\u5f97\u5c16\u7aef\u6280\u672f\u7684\u673a\u4f1a\u52a0\u5f3a\u75c5\u4eba\u7684\u62a4\u7406.
\u201c\u4e0eisoSolutions\u7684\u5408\u4f5c\u662f\u6838\u533b\u5b66\u521b\u65b0\u7684\u4e00\u4e2a\u91cd\u8981\u65f6\u523b,\u201d<\/em> deidre Prince\u535a\u58eb\u8bf4 iThemba LABS\u7684\u6838\u533b\u5b66\u4e3b\u7ba1 \u201ciThemba 68Ge\/68Ga\u53d1\u7535\u673a\u662f\u5728\u5357\u975e\u901a\u8fc7\u5c16\u7aef\u7814\u7a76\u548c\u6280\u672f\u5f00\u53d1\u7684,\u5c06\u5927\u5927\u6539\u8fdb\u4e16\u754c\u5404\u5730\u7684PET\u6210\u50cf\u3002 \u6211\u4eec\u6e34\u671b\u4e0e\u52a0\u62ff\u5927\u536b\u751f\u90e8\u5408\u4f5c,\u5c06\u8fd9\u4e00\u91cd\u8981\u5de5\u5177\u5e26\u7ed9\u4fdd\u5065\u63d0\u4f9b\u8005,\u52a0\u5f3a\u8bca\u65ad,\u6539\u5584\u5168\u7403\u8303\u56f4\u7684\u75c5\u4eba\u7ed3\u679c\u201d.
isoSolutions\u7684\u9996\u5e2d\u6267\u884c\u5b98\u963f\u4f26\u00b7\u8f9b\u683c(Arun Singh)\u8865\u5145\u8bf4, \u201c\u8fd9\u4e2aDMF\u63d0\u6848\u7a81\u51fa\u8868\u660e,\u6211\u4eec\u5171\u540c\u81f4\u529b\u4e8e\u63d0\u4f9b\u80fd\u591f\u6539\u53d8\u75c5\u4eba\u62a4\u7406\u7684\u9ad8\u8d28\u91cf\u6210\u50cf\u89e3\u51b3\u65b9\u6848\u3002 \u6211\u4eec\u671f\u5f85\u7740\u4e0eiThemba LABS\u548c\u52a0\u62ff\u5927\u536b\u751f\u90e8\u5bc6\u5207\u5408\u4f5c,\u786e\u4fddiThemba LABS 68Ge\/68Ga\u53d1\u7535\u673a\u7684\u6210\u529f\u5546\u4e1a\u5316\u3002\u201d<\/em>
IThemba LABS 68Ge\/68Ga\u53d1\u7535\u673a\u7684\u4e3b\u8981\u6548\u76ca:<\/em><\/strong>
\u53ef\u9760\u4f9b\u5e94:\u53d1\u7535\u673a\u786e\u4fddGa-68\u7684\u8fde\u7eed\u4f9b\u5e94\u548c\u6309\u9700\u4f9b\u5e94,\u6ee1\u8db3\u4fdd\u5065\u8bbe\u65bd\u5bf9\u53ca\u65f6\u8fdb\u884cPET\u6210\u50cf\u7684\u65e5\u76ca\u589e\u957f\u7684\u9700\u6c42.
\u64cd\u4f5c\u6548\u7387:\u4e3a\u5feb\u901f\u6709\u6548\u751f\u4ea7\u800c\u8bbe\u8ba1,Ga-68\u53d1\u7535\u673a\u5c06\u75c5\u4eba\u7b49\u5f85\u65f6\u95f4\u51cf\u5c11\u5230\u6700\u4f4e\u7a0b\u5ea6,\u5e76\u4f18\u5316\u8bca\u65ad\u6210\u50cf\u4e2d\u5fc3\u7684\u64cd\u4f5c\u6d41\u91cf.
\u5177\u6709\u6210\u672c\u6548\u76ca\u7684\u89e3\u51b3\u65b9\u6848:Ga-68\u53d1\u7535\u673a\u901a\u8fc7\u4f7f\u5185\u90e8\u7684\u653e\u5c04\u7ba1\u751f\u4ea7\u6210\u4e3a\u53ef\u80fd,\u63d0\u4f9b\u4e86\u4e00\u4e2a\u6210\u672c\u6548\u76ca\u9ad8\u7684\u66ff\u4ee3\u54c1,\u4f7f\u60a3\u8005\u66f4\u5bb9\u6613\u83b7\u5f97\u5148\u8fdb\u7684\u8bca\u65ad\u6210\u50cf.
\u52a0\u62ff\u5927\u536b\u751f\u90e8\u7684\u5ba1\u67e5\u8fc7\u7a0b\u5c06\u4e3aiThemba LABS 68Ge\/68Ga\u53d1\u7535\u673a\u7684\u5546\u4e1a\u5316\u94fa\u5e73\u9053\u8def,\u6709\u53ef\u80fd\u5728\u52a0\u62ff\u5927\u5404\u5730\u7684\u8bca\u65ad\u6210\u50cf\u8bbe\u65bd\u4e2d\u5e7f\u6cdb\u91c7\u7528.
\u5173\u4e8eiThemba LABS 68Ge\/68Ga\u751f\u6210\u5668\u4ee5\u53caiThemba LABS\u548cisoSolutions\u4e4b\u95f4\u7684\u5408\u4f5c,\u8bf7\u8bbf\u95ee\u6211\u4eec\u7684\u7f51\u7ad9\u6216\u8054\u7cfb\u6211\u4eec\u7684\u5a92\u4f53\u5173\u7cfb\u5c0f\u7ec4.<\/p>\n

\u5173\u4e8eiThemba LABS:<\/strong>
iThemba LABS\u662f\u533b\u5b66\u6210\u50cf\u7684\u9886\u5148\u521b\u65b0\u8005,\u4e13\u6ce8\u4e8e\u5f00\u53d1\u5f3a\u5316\u60a3\u8005\u62a4\u7406\u7684\u5148\u8fdb\u89e3\u51b3\u65b9\u6848. iThemba\u81f4\u529b\u4e8e\u63d0\u9ad8\u8d28\u91cf\u548c\u6548\u529b,\u65e8\u5728\u5411\u4fdd\u5065\u63d0\u4f9b\u8005\u63d0\u4f9b\u6700\u5148\u8fdb\u7684\u8bca\u65ad\u5de5\u5177.<\/p>\n

\u5173\u4e8eNRF:<\/strong>
\u56fd\u5bb6\u7814\u7a76\u57fa\u91d1\u4f1a\u662f\u6839\u636e\u300a\u56fd\u5bb6\u7814\u7a76\u57fa\u91d1\u4f1a\u6cd5\u300b\u8bbe\u7acb\u7684\u4e00\u4e2a\u72ec\u7acb\u7684\u6cd5\u5b9a\u673a\u6784\u3002 \u5176\u4efb\u52a1\u662f\u901a\u8fc7\u4f9b\u8d44\u3001\u4eba\u529b\u8d44\u6e90\u5f00\u53d1\u548c\u63d0\u4f9b\u5fc5\u8981\u7684\u7814\u7a76\u8bbe\u65bd,\u652f\u6301\u548c\u4fc3\u8fdb\u7814\u7a76,\u4ee5\u4fc3\u8fdb\u5728\u5305\u62ec\u571f\u8457\u77e5\u8bc6\u5728\u5185\u7684\u6240\u6709\u79d1\u5b66\u6280\u672f\u9886\u57df\u521b\u9020\u77e5\u8bc6\u3001\u521b\u65b0\u548c\u53d1\u5c55;\u53d1\u5c55\u3001\u652f\u6301\u548c\u7ef4\u62a4\u56fd\u5bb6\u7814\u7a76\u8bbe\u65bd;\u652f\u6301\u548c\u4fc3\u8fdb\u516c\u4f17\u5bf9\u79d1\u5b66\u7684\u8ba4\u8bc6\u548c\u63a5\u89e6;\u4fc3\u8fdb\u53d1\u5c55\u548c\u7ef4\u62a4\u56fd\u5bb6\u79d1\u5b66\u4f53\u7cfb,\u652f\u6301\u653f\u5e9c\u7684\u4f18\u5148\u4e8b\u9879,\u4ece\u800c\u6709\u52a9\u4e8e\u63d0\u9ad8\u6240\u6709\u5357\u975e\u4eba\u7684\u751f\u6d3b\u8d28\u91cf.<\/p>\n

\u7ea6 isoSolutions :<\/strong>
isoSolutions\u662f\u533b\u7597\u6210\u50cf\u548c\u6cbb\u7597\u4ea7\u54c1\u7684\u5168\u7403\u7ecf\u9500\u5546,\u81f4\u529b\u4e8e\u63d0\u4f9b\u521b\u65b0\u7684\u89e3\u51b3\u65b9\u6848,\u63d0\u9ad8\u8bca\u65ad\u51c6\u786e\u6027\u548c\u75c5\u4eba\u7ed3\u679c. \u4ee5\u534f\u4f5c\u548c\u5353\u8d8a\u4e3a\u91cd\u70b9,isoSolutions\u65e8\u5728\u652f\u6301\u52a0\u62ff\u5927\u5168\u56fd\u548c\u4e16\u754c\u5404\u5730\u7684\u4fdd\u5065\u63d0\u4f9b\u8005.<\/p>\n

\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u8be6\u60c5\u3001\u91c7\u8bbf\u6216\u5a92\u4f53\u8be2\u95ee,\u8bf7\u8054\u7cfb:<\/p>\n

\u56fd\u5bb6\u8d44\u6e90\u4e2d\u5fc3:
\u90a6\u52a0\u5c3c\u00b7\u6069\u79d1\u897f
\u5a92\u4f53\u5173\u7cfb\u5e72\u4e8b
NRF \u516c\u53f8\u901a\u4fe1
\u7535\u8bdd:+27 61 477 3064
\u7535\u5b50\u90ae\u4ef6:b.nkosi@nrf.ac.za<\/p>\n

iTHEMBA LABS: (\u82f1\u8bed)
\u9edb\u6bd4\u30fb\u514b\u91cc\u65af\u8482\u5b89
\u7535\u8bdd:+(27)21-843-1338
\u7535\u5b50\u90ae\u4ef6:debbie@tlabs.ac.za
\u7f51\u7ad9:tlabs.ac.za<\/p>\n

isoSolutions: \u7535\u78c1\u6ce2
\u9a6c\u6587\u00b7\u5361\u5c14\u5fb7\u9f99
\u7535\u8bdd:+1 (604) 669-7277
\u7535\u5b50\u90ae\u4ef6:mcalderon@isosolutions.com
\u7f51\u5740:www.isosolutions.com<\/p>\n

\u5173\u4e8e\u56fd\u5bb6\u6210\u679c\u6846\u67b6\u7f51\u7ad9\u7684\u53c2\u8003\u8d44\u6599:<\/p>\n

https:\/\/www.nrf.ac.za\/nrf-ithemba-labs-and-isosolutions-bring-major-boost-to-canadas-innovative-diagnostic-capabilities\/<\/a><\/p>\n

\u5e76\u901a\u8fc7X:<\/p>\n

https:\/\/x.com\/NRF_News\/status\/1887847514902016212?t=uxIEEKbw6In8dM0n78d-tg&s=08<\/a><\/p>","protected":false},"excerpt":{"rendered":"

68Ge\/68Ga \u53d1\u7535\u673a DMF\u4e0eiThemba LABS\u5408\u4f5c\u5b58\u6863.<\/p>","protected":false},"featured_media":172,"template":"","iso_news_section":[42,43],"class_list":["post-9","iso_news","type-iso_news","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/wp-json\/wp\/v2\/iso_news\/9","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/wp-json\/wp\/v2\/iso_news"}],"about":[{"href":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/wp-json\/wp\/v2\/types\/iso_news"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/wp-json\/wp\/v2\/media\/172"}],"wp:attachment":[{"href":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/wp-json\/wp\/v2\/media?parent=9"}],"wp:term":[{"taxonomy":"iso_news_section","embeddable":true,"href":"https:\/\/isosolution-v2.staging.xiyx.ai\/zh\/wp-json\/wp\/v2\/iso_news_section?post=9"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}