{"id":1877,"date":"2024-09-25T17:18:28","date_gmt":"2024-09-25T09:18:28","guid":{"rendered":"https:\/\/www.vcro.com.tw\/tw\/?p=1877"},"modified":"2024-09-26T09:59:32","modified_gmt":"2024-09-26T01:59:32","slug":"%e7%b6%ad%e5%b7%9e%e5%bf%ab%e8%a8%8a%ef%bc%9afda%e7%99%bc%e5%b8%83%e6%96%b0%e6%8c%87%e5%b0%8e%e5%8e%9f%e5%89%87%e4%b9%8b%e8%85%ab%e7%98%a4%e7%94%a2%e5%93%81%e5%a4%9a%e5%9c%b0%e5%8d%80%e8%87%a8","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1877","title":{"rendered":"\u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"675\" src=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/\u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20-1024x675.png\" alt=\"VCRO \u7dad\u5dde\u751f\u7269\u79d1\u6280 \u7dad\u5dde\u5feb\u8a0a \u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20\" class=\"wp-image-1878\" srcset=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/\u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20-1024x675.png 1024w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/\u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20-300x198.png 300w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/\u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20-768x506.png 768w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/\u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20.png 1346w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"685\" src=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/FDA\u7533\u5831\u816b\u7624\u9069\u61c9\u75c7\u7522\u54c1\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u5283\u8b49\u64da\u7684\u8003\u616e\u56e0\u7d20-1024x685.png\" alt=\"VCRO \u7dad\u5dde\u751f\u7269\u79d1\u6280 \u7dad\u5dde\u5feb\u8a0a \u7dad\u5dde\u5feb\u8a0a\uff1aFDA\u767c\u5e03\u65b0\u6307\u5c0e\u539f\u5247\u4e4b\u816b\u7624\u7522\u54c1\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u91cf\u56e0\u7d20\" class=\"wp-image-1879\" srcset=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/FDA\u7533\u5831\u816b\u7624\u9069\u61c9\u75c7\u7522\u54c1\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u5283\u8b49\u64da\u7684\u8003\u616e\u56e0\u7d20-1024x685.png 1024w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/FDA\u7533\u5831\u816b\u7624\u9069\u61c9\u75c7\u7522\u54c1\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u5283\u8b49\u64da\u7684\u8003\u616e\u56e0\u7d20-300x201.png 300w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/FDA\u7533\u5831\u816b\u7624\u9069\u61c9\u75c7\u7522\u54c1\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u5283\u8b49\u64da\u7684\u8003\u616e\u56e0\u7d20-768x514.png 768w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/09\/FDA\u7533\u5831\u816b\u7624\u9069\u61c9\u75c7\u7522\u54c1\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u5283\u8b49\u64da\u7684\u8003\u616e\u56e0\u7d20.png 1334w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>FDA\u57282024\u5e749\u6708\u767c\u4f48\u4e86guidance &#8220;Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs Guidance for Industry&#8221;<br><a href=\"https:\/\/www.fda.gov\/media\/181824\/download\">https:\/\/www.fda.gov\/media\/181824\/download<\/a><\/p>\n\n\n\n<p>\u5176\u4e2d\u7684\u91cd\u9ede\u5982\u4e0b\uff1a\u816b\u7624\u9069\u61c9\u75c7\u7522\u54c1\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u8b49\u64da\u7684\u8003\u616e\u56e0\u7d20\u3002<br>\u5728\u5168\u7403\u7bc4\u570d\u5167\u958b\u5c55\u816b\u7624\u85e5\u7269\u7684\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\uff08MRCT\uff09\u6642\uff0c\u78ba\u4fdd\u7372\u5f97\u6709\u6548\u7684\u81e8\u5e8a\u8b49\u64da\u662f\u81f3\u95dc\u91cd\u8981\u7684\u3002\u70ba\u6b64\uff0c\u7533\u8fa6\u65b9\u9700\u8981\u4ed4\u7d30\u8003\u616e\u591a\u500b\u65b9\u9762\uff0c\u5f9e\u7f8e\u570b\u4eba\u53e3\u7684\u4ee3\u8868\u6027\u5230\u8207FDA\u53ca\u5176\u4ed6\u76e3\u7ba1\u6a5f\u69cb\u7684\u65e9\u671f\u8aee\u8a62\u3002\u672c\u6587\u5c07\u8a73\u7d30\u63a2\u8a0e\u9019\u4e9b\u95dc\u9375\u56e0\u7d20\uff0c\u4e26\u63d0\u4f9b\u6709\u95dc\u5982\u4f55\u512a\u5316\u81e8\u5e8a\u8a66\u9a57\u7b56\u7565\u7684\u5be6\u7528\u5efa\u8b70\u3002<\/p>\n\n\n\n<p>\u7533\u8fa6\u65b9\u61c9\u78ba\u4fdd\u5176 CDP \u7684\u7d50\u679c\uff08\u5305\u62ec MRCT\uff09\u9069\u7528\u65bc\u7372\u5f97\u6279\u51c6\u5f8c\u5c07\u670d\u7528\u8a72\u85e5\u7269\u7684\u7f8e\u570b\u4eba\u7fa4\u4ee5\u53ca\u7f8e\u570b\u7684\u91ab\u7642\u5be6\u8e10\u3002\u7533\u8fa6\u65b9\u61c9\u4ed4\u7d30\u8003\u616e\u4f7f\u7528\u591a\u5340\u57df\u65b9\u6cd5\u9032\u884c\u7684 CDP \u5728\u79d1\u5b78\u3001\u81e8\u5e8a\u548c\u5176\u4ed6\u56e0\u7d20\u7684\u80cc\u666f\u4e0b\u662f\u5426\u5408\u9069\u3002\u4f8b\u5982\uff0c\u764c\u75c7\u7684\u76db\u884c\u7387\u3001\u8868\u73fe\u3001\u75c5\u56e0\u6216\u56b4\u91cd\u7a0b\u5ea6\u53ef\u80fd\u5b58\u5728\u4e0d\u540c\u570b\u5bb6\u6216\u5730\u5340\u7684\u5df2\u77e5\u5dee\u7570\uff0c\u4e26\u53ef\u80fd\u5f71\u97ff\u5c0d\u7f8e\u570b\u4eba\u53e3\u548c\u7f8e\u570b\u91ab\u7642\u5be6\u8e10\u7684\u9069\u7528\u6027\u3002\u5728\u8a55\u4f30 CDP\uff08\u5305\u62ec\u91dd\u5c0d\u7279\u5b9a\u85e5\u7269\u548c\u81e8\u5e8a\u74b0\u5883\u7684\u591a\u5340\u57df\u81e8\u5e8a\u8a66\u9a57\uff09\u7684\u9069\u7576\u6027\u6642\uff0c\u7533\u8fa6\u65b9\u61c9\u81f3\u5c11\u8003\u616e\u4ee5\u4e0b\u56e0\u7d20\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u75c5\u60a3\u76f8\u95dc\u56e0\u6578\uff08\u4f8b\u5982\uff0c\u63a5\u89f8\u75be\u75c5\u5371\u96aa\u56e0\u6578\u3001\u907a\u50b3\u7956\u5148\u80cc\u666f\uff09\u3002<\/li>\n\n\n\n<li>\u75be\u75c5\u76f8\u95dc\u56e0\u7d20\uff08\u4f8b\u5982\uff0c\u75be\u75c5\u4e9e\u578b\u7684\u76db\u884c\u7387\u3001\u65cf\u7fa4\u4e2d\u67d0\u4e9b\u81f4\u764c\u5206\u5b50\u9a45\u52d5\u56e0\u6578\u7684\u983b\u7387\u548c\u5206\u4f48\uff09\u3002<\/li>\n\n\n\n<li>\u91ab\u7642\u4fdd\u5065\u7cfb\u7d71\u56e0\u7d20\uff08\u4f8b\u5982\uff0c\u7372\u5f97\u91ab\u7642\u4fdd\u5065\u7684\u6a5f\u6703\uff0c\u5305\u62ec\u5c08\u9580\u7684\u816b\u7624\u5b78\u8b77\u7406\u3001\u764c\u75c7\u7be9\u6aa2\u5be6\u8e10\u3001\u764c\u75c7\u6cbb\u7642\u7684\u53ef\u7528\u6027\u548c\u8ca0\u64d4\u80fd\u529b\uff09\u53ef\u80fd\u6703\u5f71\u97ff\u5148\u524d\u63a5\u53d7\u7684\u6cbb\u7642\u548c\u81e8\u5e8a\u8abf\u67e5\u5f8c\u53ef\u7528\u7684\u6cbb\u7642\u3002<\/li>\n\n\n\n<li>\u793e\u6703\u6587\u5316\u56e0\u7d20\uff08\u4f8b\u5982\u98f2\u98df\u3001\u95dc\u65bc\u4f7f\u7528\u300c\u66ff\u4ee3\u300d\u7642\u6cd5\u6cbb\u7642\u764c\u75c7\u7684\u6587\u5316\u4fe1\u5ff5\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u7531\u65bc\u4e0a\u8ff0\u56e0\u7d20\u6709\u53ef\u80fd\u5f71\u97ff MRCT \u7684\u81e8\u5e8a\u7d50\u679c\uff0c\u7533\u8fa6\u65b9\u61c9\u4ed4\u7d30\u8a55\u4f30\u5b83\u5011\uff0c\u4f5c\u70ba\u5176 CDP \u53ef\u884c\u6027\u8a55\u4f30\u7684\u4e00\u90e8\u5206\u3002\u4ee5\u4e0b\u5efa\u8b70\u5217\u51fa\u4e86\u7533\u8fa6\u65b9\u5728\u898f\u5283\u591a\u5340\u57df CDP \u6642\u61c9\u8003\u616e\u7684\u554f\u984c\u7684\u975e\u8a73\u76e1\u6e05\u55ae\uff0c\u4ee5\u78ba\u4fdd MRCT \u7684\u7d50\u679c\u9069\u7528\u65bc\u7f8e\u570b\u4eba\u53e3\u548c\u7f8e\u570b\u91ab\u7642\u5be6\u8e10\u3002<\/p>\n\n\n\n<p><strong>A. \u7f8e\u570b\u4eba\u53e3\u5728MRCT\u4e2d\u7684\u4ee3\u8868\u6027<\/strong><br>\u5728\u9032\u884c\u591a\u5730\u5340\u81e8\u5e8a\u958b\u767c\u8a08\u756b\u6642\uff0c\u78ba\u4fdd\u7f8e\u570b\u60a3\u8005\u7684\u4ee3\u8868\u6027\u81f3\u95dc\u91cd\u8981\u3002\u9019\u4e0d\u50c5\u6709\u52a9\u65bc\u8a55\u4f30\u85e5\u7269\u5728\u7f8e\u570b\u4eba\u7fa4\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u9084\u80fd\u78ba\u4fdd\u8a66\u9a57\u7d50\u679c\u5728\u7f8e\u570b\u6a19\u6e96\u6cbb\u7642\u5be6\u8e10\u4e2d\u7684\u9069\u7528\u6027\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8a66\u9a57\u4eba\u7fa4\u7684\u4ee3\u8868\u6027\uff1a<\/strong>\u7531\u65bc\u4e0d\u540c\u5730\u5340\u7684\u8a66\u9a57\u4eba\u7fa4\u53ef\u80fd\u5b58\u5728\u986f\u8457\u5dee\u7570\uff0c\u9019\u4e9b\u5dee\u7570\u901a\u5e38\u5728\u8a66\u9a57\u5b8c\u6210\u4e26\u5b8c\u5168\u5206\u6790\u5f8c\u624d\u6703\u986f\u73fe\u3002\u70ba\u4e86\u78ba\u4fdd\u8a66\u9a57\u8cc7\u6599\u7684\u5168\u9762\u6027\uff0c\u7533\u8fa6\u65b9\u61c9\u5728\u8a66\u9a57\u4e2d\u62db\u52df\u8db3\u5920\u6578\u91cf\u7684\u7f8e\u570b\u53c3\u8207\u8005\u3002\u9019\u5c07\u5e6b\u52a9\u751f\u6210\u80fd\u5920\u5145\u5206\u53cd\u6620\u7f8e\u570b\u60a3\u8005\u7fa4\u9ad4\u7684\u8b49\u64da\u3002<\/li>\n\n\n\n<li><strong>\u65e9\u671f\u968e\u6bb5\u7684\u7814\u7a76\uff1a<\/strong>\u5728\u65e9\u671f\u968e\u6bb5\uff08\u5982\u85e5\u4ee3\u52d5\u529b\u5b78\u3001\u85e5\u7406\u57fa\u56e0\u7d44\u5b78\u3001\u5291\u91cf\u63a2\u7d22\u548c\u6d3b\u6027\u8a55\u4f30\uff09\u7814\u7a76\u4e2d\uff0c\u61c9\u76e1\u53ef\u80fd\u5728\u5177\u6709\u4ee3\u8868\u6027\u7684\u4eba\u7fa4\u4e2d\u9032\u884c\u3002\u9019\u4e9b\u7814\u7a76\u6709\u52a9\u65bc\u65e9\u671f\u8b58\u5225\u85e5\u7269\u5728\u4e0d\u540c\u4eba\u7fa4\u4e2d\u7684\u6548\u61c9\u5dee\u7570\u3002\u4f8b\u5982\uff0c\u9019\u4e9b\u7814\u7a76\u53ef\u4ee5\u63d0\u4f9b\u6709\u95dc\u85e5\u4ee3\u52d5\u529b\u5b78\u3001\u98f2\u98df\u7fd2\u6163\u3001\u66ff\u4ee3\u85e5\u7269\u4f7f\u7528\u3001\u85e5\u7269\u907a\u50b3\u5b78\u3001\u7a2e\u65cf\u548c\u6027\u5225\u7b49\u56e0\u7d20\u7684\u521d\u6b65\u8cc7\u8a0a\uff0c\u4e26\u70ba\u672a\u4f86\u7684MRCT\u8a2d\u8a08\u63d0\u4f9b\u4f9d\u64da\u3002<\/li>\n\n\n\n<li><strong>FDA<\/strong><strong>\u7684\u5efa\u8b70\uff1a<\/strong>FDA\u5efa\u8b70\uff0c\u91dd\u5c0d\u5728\u7f8e\u570b\u5e38\u898b\u7684\u764c\u75c7\uff08\u5982\u7d50\u76f4\u8178\u764c\u6216\u4e73\u817a\u764c\uff09\u7684\u85e5\u7269\u8a66\u9a57\uff0c\u61c9\u5728\u4e3b\u8981\u5730\u7406\u5340\u57df\uff08\u5305\u62ec\u5317\u7f8e\uff09\u4e2d\u5e73\u7b49\u5206\u914d\u7814\u7a76\u53c3\u8207\u8005\u3002\u5c0d\u65bc\u5728\u7f8e\u570b\u767c\u751f\u7387\u8f03\u4f4e\u4f46\u5728\u5176\u4ed6\u5730\u5340\u8f03\u9ad8\u7684\u764c\u75c7\uff08\u5982\u9c57\u72c0\u7d30\u80de\u98df\u7ba1\u764c\uff09\uff0c\u5247\u5efa\u8b70\u63a1\u7528\u6bd4\u4f8b\u5206\u914d\u65b9\u6cd5\u3002\u901a\u904e\u9019\u7a2e\u65b9\u5f0f\uff0c\u53ef\u4ee5\u78ba\u4fdd\u85e5\u7269\u6548\u679c\u7684\u8a55\u4f30\u4e0d\u53d7\u5730\u5340\u5dee\u7570\u7684\u5f71\u97ff\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>B. \u7f8e\u570b\u548c\u5916\u570b\u5730\u9ede\u9078\u64c7\u7684\u8003\u616e<\/strong><br>\u9078\u64c7\u9069\u5408\u7684\u8a66\u9a57\u5730\u9ede\u5c0d\u65bc\u78ba\u4fdd\u8cc7\u6599\u7684\u54c1\u8cea\u548c\u4ee3\u8868\u6027\u81f3\u95dc\u91cd\u8981\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8a66\u9a57\u5730\u9ede\u7684\u9078\u64c7\uff1a<\/strong>\u4e00\u822c\u800c\u8a00\uff0cFDA\u5efa\u8b70\u5c07\u816b\u7624\u5b78MRCT\u5206\u4f48\u65bc\u4e3b\u8981\u5730\u7406\u5340\u57df\uff08\u4f8b\u5982\u8de8\u8d8a\u591a\u500b\u5927\u9678\uff09\uff0c\u800c\u4e0d\u662f\u55ae\u4e00\u570b\u5bb6\u6216\u5730\u7406\u5340\u57df\u3002\u9019\u6709\u52a9\u65bc\u78ba\u4fdd\u8a66\u9a57\u7d50\u679c\u5177\u6709\u5ee3\u6cdb\u7684\u9069\u7528\u6027\u3002<\/li>\n\n\n\n<li><strong>\u5730\u7406\u5340\u57df\u7684\u5408\u7406\u6027\uff1a<\/strong>\u5728\u8207FDA\u8a0e\u8ad6\u8a66\u9a57\u8a2d\u8a08\u6642\uff0c\u7533\u8fa6\u65b9\u61c9\u8a73\u7d30\u8aaa\u660e\u6240\u9078\u5730\u7406\u5340\u57df\u53ca\u5176\u6a23\u672c\u91cf\u5206\u914d\u7684\u5408\u7406\u6027\u3002\u9019\u5305\u62ec\u63cf\u8ff0\u5404\u5730\u7406\u5340\u57df\u5728\u60a3\u8005\u3001\u75be\u75c5\u548c\u91ab\u7642\u7cfb\u7d71\u76f8\u95dc\u56e0\u7d20\u4e0a\u7684\u5dee\u7570\u548c\u76f8\u4f3c\u6027\u3002<\/li>\n\n\n\n<li><strong>\u81e8\u5e8a\u8a66\u9a57\u5730\u9ede\u7684\u904e\u5f80\u7d93\u9a57\uff1a<\/strong>\u7533\u8fa6\u65b9\u61c9\u9078\u64c7\u6709\u826f\u597d\u8a18\u9304\u7684\u81e8\u5e8a\u8a66\u9a57\u5730\u9ede\uff0c\u7279\u5225\u662f\u90a3\u4e9b\u5728\u4ee5\u5f80\u816b\u7624\u5b78\u81e8\u5e8a\u8a66\u9a57\u4e2d\u6709\u7d93\u9a57\u7684\u5730\u9ede\u3002\u5c0d\u65bc\u975e\u7f8e\u570b\u5730\u9ede\uff0c\u9019\u53ef\u4ee5\u5305\u62ec\u570b\u969b\u5354\u8abf\u6703\uff08ICH\uff09\u5340\u57df\u5167\u7684\u5730\u9ede\u3002\u78ba\u4fdd\u9019\u4e9b\u5730\u9ede\u7b26\u5408\u9069\u7528\u6cd5\u5f8b\u6cd5\u898f\u548c\u81e8\u5e8a\u8a66\u9a57\u826f\u597d\u64cd\u4f5c\u898f\u7bc4\uff08GCP\uff09\u7684\u8981\u6c42\u3002<\/li>\n\n\n\n<li><strong>\u63a2\u7d22\u975e\u50b3\u7d71\u74b0\u5883\uff1a<\/strong>\u7533\u8fa6\u65b9\u9084\u61c9\u8003\u616e\u5728\u975e\u50b3\u7d71\u74b0\u5883\uff08\u5982\u793e\u5340\u91ab\u9662\u3001\u793e\u5340\u764c\u75c7\u4e2d\u5fc3\uff09\u4e2d\u8a2d\u7acb\u8a66\u9a57\u5730\u9ede\uff0c\u4ee5\u63d0\u9ad8\u62db\u52df\u5177\u6709\u4ee3\u8868\u6027\u7814\u7a76\u4eba\u7fa4\u7684\u6a5f\u6703\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>C. \u75be\u75c5\u3001\u53ef\u7528\u6cbb\u7642\u548c\u91ab\u7642\u7522\u54c1\u7684\u8003\u616e<\/strong><br>\u8a55\u4f30\u75be\u75c5\u7684\u5730\u5340\u5dee\u7570\u4ee5\u53ca\u53ef\u7528\u6cbb\u7642\u5c0d\u8a66\u9a57\u7d50\u679c\u7684\u5f71\u97ff\u4e5f\u662f\u81f3\u95dc\u91cd\u8981\u7684\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u75be\u75c5\u7279\u5fb5\u7684\u5730\u5340\u5dee\u7570\uff1a<\/strong>\u7533\u8fa6\u65b9\u5728\u6c7a\u5b9a\u662f\u5426\u63a1\u7528\u591a\u5730\u5340\u65b9\u6cd5\u6642\uff0c\u61c9\u8003\u616e\u75be\u75c5\u7684\u5730\u5340\u5dee\u7570\uff0c\u5982\u767c\u75c5\u7387\u3001\u6d41\u884c\u7387\u3001\u98a8\u96aa\u56e0\u7d20\u3001\u767c\u75c5\u5e74\u9f61\u3001\u764c\u75c7\u7d44\u7e54\u5b78\u5206\u4f48\u548c\u53ef\u7528\u6cbb\u7642\u7b49\u3002\u5982\u679c\u67d0\u764c\u75c7\u4e9e\u578b\u5728\u7f8e\u570b\u662f\u4e3b\u8981\u8868\u73fe\uff0c\u7533\u8fa6\u65b9\u61c9\u9078\u64c7\u80fd\u5920\u5728\u5927\u91cf\u60a3\u6709\u8a72\u4e9e\u578b\u7684\u60a3\u8005\u4e2d\u8a55\u4f30\u8a66\u9a57\u85e5\u7269\u7684\u81e8\u5e8a\u8a66\u9a57\u5730\u9ede\u3002<\/li>\n\n\n\n<li><strong>\u5c0d\u7167\u7d44\u7684\u6a19\u6e96\u6cbb\u7642\uff1a<\/strong>\u5728\u8a55\u4f30\u5916\u570b\u7db2\u7ad9\u7684\u53ef\u7528\u6a19\u6e96\u6cbb\u7642\u6642\uff0c\u7533\u8fa6\u65b9\u61c9\u5305\u62ec\u5c0d\u7167\u7d44\u6cbb\u7642\u7684\u53ef\u7528\u6027\u8a55\u4f30\uff0c\u4e26\u5728\u8a66\u9a57\u898f\u5283\u968e\u6bb5\u5c07\u6b64\u8cc7\u8a0a\u63d0\u4f9b\u7d66FDA\u3002\u5c0d\u7167\u7d44\u4e2d\u7684\u6cbb\u7642\u61c9\u53cd\u6620\u7f8e\u570b\u7684\u6a19\u6e96\u6cbb\u7642\uff0c\u4ee5\u78ba\u4fdd\u8a66\u9a57\u7d50\u679c\u9069\u7528\u65bc\u7f8e\u570b\u4eba\u7fa4\u3002\u5982\u679c\u5916\u570b\u7db2\u7ad9\u7684\u6a19\u6e96\u6cbb\u7642\u8207\u7f8e\u570b\u4e0d\u4e00\u81f4\uff0c\u7533\u8fa6\u65b9\u61c9\u8003\u616e\u662f\u5426\u53ef\u4ee5\u5728\u5c0d\u7167\u7d44\u4e2d\u5305\u62ec\u9810\u5148\u6307\u5b9a\u7684\u91ab\u751f\u9078\u64c7\u7684\u6cbb\u7642\uff0c\u9019\u4e9b\u6cbb\u7642\u5305\u62ec\u7f8e\u570b\u6a19\u6e96\u6cbb\u7642\u3002<\/li>\n\n\n\n<li><strong>\u665a\u671f\u75be\u75c5\u7684\u6cbb\u7642\uff1a<\/strong>\u5728\u8a2d\u8a08\u665a\u671f\u75be\u75c5\u7684\u8a66\u9a57\u6642\uff0c\u7533\u8fa6\u65b9\u61c9\u8003\u616e\u5728\u78ba\u5b9aMRCT\u8cc7\u683c\u4e4b\u524d\u5df2\u63a5\u53d7\u7684\u6cbb\u7642\u60c5\u6cc1\uff0c\u4e26\u8a55\u4f30\u75be\u75c5\u9032\u5c55\u5f8c\u7684\u53ef\u7528\u6cbb\u7642\u3002\u9019\u6709\u52a9\u65bc\u78ba\u4fdd\u8a66\u9a57\u7d50\u679c\u7684\u9069\u7528\u6027\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>D. \u591a\u5730\u5340\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\u5206\u6790\u7684\u8003\u616e<\/strong><br>\u8cc7\u6599\u5206\u6790\u662f\u78ba\u4fdd\u81e8\u5e8a\u8a66\u9a57\u7d50\u679c\u6e96\u78ba\u6027\u7684\u91cd\u8981\u6b65\u9a5f\u3002<\/p>\n\n\n\n<ul 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