{"id":98317,"date":"2019-03-15T00:00:50","date_gmt":"2019-05-17T08:13:59","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98317\/"},"modified":"2019-05-17T16:14:00","modified_gmt":"2019-05-17T08:14:00","slug":"7328a17131","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98317\/","title":{"rendered":"FDA\u5bf9\u6297\u80bf\u7624\u4eff\u5236\u836fBE\u8c41\u514d\u7684\u89c2\u70b9\u53ca\u6848\u4f8b\u5206\u6790"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><strong><span style=\"font-size: 18px;color: rgb(0, 0, 0);background-color: rgb(255, 169, 0);\">\u6765\u6e90\uff1a<span style=\"color: rgb(0, 0, 0);background-color: rgb(255, 169, 0);font-size: 18px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;widows: 1;\"><\/span><\/span><\/strong><\/p>\n<p><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;line-height: 25.6px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><img class=\"\"      style=\"box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: auto !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/6-1558080840.jpg\" alt=\"FDA\u5bf9\u6297\u80bf\u7624\u4eff\u5236\u836fBE\u8c41\u514d\u7684\u89c2\u70b9\u53ca\u6848\u4f8b\u5206\u6790\" title=\"FDA\u5bf9\u6297\u80bf\u7624\u4eff\u5236\u836fBE\u8c41\u514d\u7684\u89c2\u70b9\u53ca\u6848\u4f8b\u5206\u6790\"  \/><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<section class=\"\" style=\"max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;line-height: 25.6px;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\n<h2 class=\"\" style=\"padding-top: 5px;padding-bottom: 5px;font-weight: bold;max-width: 100%;line-height: 28px;color: rgb(55, 74, 174);min-height: 32px;border-color: rgb(55, 74, 174);border-bottom-width: 1.5px;border-bottom-style: solid;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"margin-right: 8px;padding: 4px 10px;max-width: 100%;color: rgb(255, 255, 255);display: block;float: left;line-height: 20px;background-color: rgb(55, 74, 174);box-sizing: border-box !important;overflow-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5f15\u8a00&nbsp;<\/span><\/h2>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4eff\u5236\u836f\u6d3b\u6027\u6210\u5206\u7684\u5438\u6536\u901f\u7387\u548c\u7a0b\u5ea6\u4e0e\u53c2\u6bd4\u5236\u5242\u76f8\u540c\u5219\u4e24\u79cd\u836f\u54c1\u662f\u751f\u7269\u7b49\u6548\u7684\uff0821 CFR 320.1(e) and 320.23(b)\uff09\u3002\u4eba\u4f53\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09\u7814\u7a76\u662f\u786e\u4fdd\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\uff08RLD\uff09\u7b49\u6548\u7684\u4f18\u9009\u65b9\u6cd5\u3002<span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4f53\u5185BE\u7814\u7a76\u9700\u8981\u5728\u5236\u836f\u3001\u4f26\u7406\u3001\u4e34\u5e8a\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u5206\u6790\u548c\u7edf\u8ba1\u65b9\u9762\u7cbe\u5fc3\u8bbe\u8ba1\u3002\u5b9e\u9645\u4e0a\u901a\u5e38\u96be\u4ee5\u62db\u52df\u60a3\u8005\u8fdb\u884c\u4f53\u5185\u7814\u7a76\uff0c\u5982\u75c5\u4f8b\u5c11\u6216\u75c5\u60c5\u53d1\u5c55\u5feb\u7684\u764c\u75c7\u3002\u53ef\u7528\u4f53\u5916\u8bd5\u9a8c\u4ee3\u66ffBE\u7814\u7a76\u6765\u8bc1\u660e\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\u751f\u7269\u7b49\u6548\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">FDA\u5e94\u7528BCS\u7684\u539f\u7406\u5c06\u4f53\u5916\u8bd5\u9a8c\u4f5c\u4e3a\u53e3\u670d\u901f\u91ca\u5236\u5242BE\u8c41\u514d\u7684\u4e00\u4e2a\u5de5\u5177\u3002\u6b64\u6cd5\u7684\u539f\u7406\u662f\u836f\u7269\u7684\u6eb6\u89e3\u6027\u548c\u6e17\u900f\u6027\u53ca\u836f\u54c1\u7684\u6eb6\u51fa\u5ea6\u8fd9\u4e09\u4e2a\u56e0\u7d20\u51b3\u5b9a\u4e86\u53e3\u670d\u836f\u7269\u5728\u5438\u6536\u90e8\u4f4d\u7684\u5438\u6536\u901f\u5ea6\u548c\u7a0b\u5ea6\u3002BCS I\u7c7b\u836f\u7269\u5177\u6709\u9ad8\u6eb6\u89e3\u6027\u548c\u9ad8\u6e17\u900f\u6027\uff0c\u5982\u679c\u5c06BCS 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!important;\">FDA\u4e8e1995\u5e74\u5f00\u59cb\u5b9e\u65bdBCS\u6a21\u5f0f\u4f5c\u4e3a\u76d1\u7ba1\u5de5\u5177\uff0c\u5f53\u65f6\u53d1\u5e03\u4e86\u901f\u91ca\u5236\u5242\uff08IR\uff09\u653e\u5927\u751f\u4ea7\u548c\u6279\u51c6\u540e\u53d8\u66f4\uff08SUPAC\uff09\u6307\u5357\uff0c\u5728\u8be5\u6307\u5357\u4e2d\u4ecb\u7ecd\u4e86\u9ad8\u6eb6\u89e3\u6027\u548c\u9ad8\u6e17\u900f\u6027\u836f\u7269\u7684\u76d1\u7ba1\u30021995\u5e74\u81f32000\u5e74\u751f\u7269\u8c41\u514d\u4ec5\u9650\u4e8e\u8be5\u836f\u54c1\u7684\u653e\u5927\u6216\u5176\u4ed6\u53d8\u66f4\u7684\u8865\u5145\u30022000\u5e748\u6708FDA\u53d1\u5e03BCS\u6307\u5357\uff0c\u6269\u5927\u4e86\u5bf9\u542b\u6709BCS I\u7c7b\u836f\u7269\u7684\u53e3\u670d\u901f\u91ca\u5236\u5242\u7684\u76d1\u7ba1\u8003\u8651\u3002FDA\u5728\u8be5\u6307\u5357\u4e2d\u8fdb\u4e00\u6b65\u9610\u8ff0\u4e86\u9ad8\u6e17\u900f\u6027\u836f\u7269\u7684\u5b9a\u4e49\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u542bBCS I\u7c7b\u7684\u836f\u54c1\uff0c\u4eff\u5236\u836f\u529e\u516c\u5ba4\uff08OGD\uff09\u9f13\u52b1\u7533\u8bf7\u4eba\u7533\u8bf7\u8c41\u514d\u4f53\u5185BE\u7814\u7a76\uff0c\u5e76\u63d0\u4f9b\u5173\u4e8e\u836f\u7269\u9ad8\u6eb6\u89e3\u6027\u548c\u9ad8\u6e17\u900f\u6027\u3001\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d\u7684\u7a33\u5b9a\u6027\u548c\u836f\u7269\u5feb\u901f\u6eb6\u51fa\u7684\u76f8\u5173\u6587\u4ef6\uff0c\u8be6\u89c1BCS\u6307\u5357\u3002OGD\u5df2\u7ecf\u5ba1\u67e5\u548c\u6279\u51c6\u4e86\u51e0\u79cd\u6297\u591a\u6e90\u6027\u80bf\u7624\u836f\u7269\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u7533\u8bf7\u3002<span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5bf9\u4e8e\u6297\u80bf\u7624\u836f\u7269\uff0c\u8003\u8651\u5230\u8fdb\u884c\u4f53\u5185BE\u7814\u7a76\u7684\u590d\u6742\u6027\uff0c\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u5177\u6709\u8bb8\u591a\u4f18\u70b9\u3002\u5bf9\u4e8e\u5177\u6709\u7ec6\u80de\u6bd2\u6027\u7684\u6297\u80bf\u7624\u836f\u7269\u4e5f\u662f\u5982\u6b64\u3002\u901a\u5e38\u5728\u5065\u5eb7\u5fd7\u613f\u8005\u4f53\u5185\u8fdb\u884c\u7ec6\u80de\u6bd2\u6027\u836f\u7269\u7684\u7814\u7a76\u662f\u4e0d\u9053\u5fb7\u7684\u3002<\/span>21 CFR 320.31\u6587\u4ef6\u6307\u51fa\u4eff\u5236\u7a76\u4f01\u4e1a\u5728\u8fdb\u884cBE\u7814\u7a76\u4e4b\u524d\u9700\u8981\u63d0\u4ea4\u4e00\u4efd\u4e34\u5e8a\u65b0\u836f\uff08IND\uff09\u7533\u8bf7\u5ba1\u67e5\uff08\u4e5f\u79f0\u4e3aBio-IND\uff09\u3002\u5982\u679c\u4eba\u4f53\u5185\u7814\u7a76\u8bbe\u8ba1\u4e0d\u5b89\u5168\uff0cOGD\u5728\u5ba1\u67e5Bio-IND\u540e\u51fa\u4e8e\u5b89\u5168\u8003\u8651\u4f1a\u8ba9\u4e34\u5e8a\u8bd5\u9a8c\u6682\u505c\u3002<span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u6297\u80bf\u7624\u836f\u7269\u7684\u7814\u7a76\u9700\u8981\u5728\u591a\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u70b9\u8fdb\u884c\uff0c\u4ee5\u4fbf\u62db\u52df\u8db3\u591f\u6570\u91cf\u7684\u60a3\u8005\u3002\u6b64\u7814\u7a76\u53d7\u8bd5\u8005\u4e4b\u95f4\u7684\u53d8\u5f02\u6027\u8f83\u9ad8\uff0c\u4e0d\u826f\u4e8b\u4ef6\u8f83\u591a\uff0c\u751a\u81f3\u4f1a\u6709\u60a3\u8005\u6b7b\u4ea1\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(255, 104, 39);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u672c\u6587\u5206\u4eab\u4e86OGD\u5bf9BCS 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27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<h2 class=\"\" style=\"padding-top: 5px;padding-bottom: 5px;font-weight: bold;max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;line-height: 28px;color: rgb(55, 74, 174);min-height: 32px;border-color: rgb(55, 74, 174);border-bottom-width: 1.5px;border-bottom-style: solid;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"margin-right: 8px;padding: 4px 10px;max-width: 100%;color: rgb(255, 255, 255);display: block;float: left;line-height: 20px;background-color: rgb(55, 74, 174);box-sizing: border-box !important;overflow-wrap: break-word !important;\">2<\/span><span style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u65b9\u6cd5<\/span><\/h2>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<h2 class=\"\" style=\"padding-top: 5px;padding-bottom: 5px;font-weight: bold;max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;line-height: 28px;color: rgb(55, 74, 174);min-height: 32px;border-color: rgb(55, 74, 174);border-bottom-width: 1.5px;border-bottom-style: solid;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span class=\"\" style=\"margin-right: 8px;padding: 4px 10px;max-width: 100%;color: rgb(255, 255, 255);display: block;float: left;line-height: 20px;background-color: rgb(55, 74, 174);box-sizing: border-box !important;overflow-wrap: break-word !important;\">3<\/span>\u7ed3\u679c\u4e0e\u8ba8\u8bba<\/h2>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">CDER\u5ba1\u8bc4\u4e86\u63d0\u4ea4\u7684\u6570\u636e\u8bc4\u4f30\u4e8655\u79cd\u53e3\u670d\u901f\u91ca\u56fa\u4f53\u5236\u5242\u7684\u6570\u636e\uff0c55\u79cd\u836f\u7269\u4e2d\u768441\u79cd\u4ea7\u54c1\u7b26\u5408\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u8981\u6c42\u300241\u79cd\u836f\u7269\u4e2d\u67094\u79cd\uff08\u7ea610%\uff09\u662f\u6297\u764c\u836f\uff0c\u76f8\u6bd4\u4e4b\u4e0b\uff0cWHO\u7684\u57fa\u672c\u836f\u7269\u6e05\u5355\u4e2d\u670921\u79cd\u4e3aBCS I\u7c7b\uff0c\u53ea\u67091\u79cd\u662f\u6297\u764c\u836f\u7269\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u8fc4\u4eca\u4e3a\u6b62\uff0cOGD\u5df2\u7ecf\u901a\u8fc7\u4e86\u6211\u4eec\u7684\u8c03\u67e5\u786e\u5b9a\u76844\u79cd\u6297\u764c\u836f\u7269\u7684ANDAs\u3002\u5728\u8fd949\u4efd\u7533\u8bf7\u4e2d\uff0c30\u4efdANDAs\uff0860%\uff09\u6709\u4f53\u5185\u7684BE\u7814\u7a76\u6570\u636e\uff0c\u6570\u636e\u663e\u793a\u5728\u7981\u98df\u6216\u8fdb\u98df\u6761\u4ef6\u4e0b\u548c\u53c2\u6bd4\u5236\u5242\u7b49\u6548\u3002<span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word 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27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5bf9\u4e8e\u6709\u4f53\u5185BE\u7814\u7a76\u768430\u4e2a\u836f\u54c1\u7533\u8bf7\uff0c23\u4e2aANDAs\u5df2\u8bc4\u4f30\u5b8c\uff0c\u5e76\u4e14\u8fd923\u4e2aANDA\u4e2d\u768411\u4e2a\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u53ef\u4ee5\u63a5\u53d7\uff0c\u4ec5\u9700\u8981\u4e00\u4e2aBE\u5ba1\u8bc4\u5468\u671f\u3002\u8fd9\u5360\u4e86\u8fd9\u4e00\u7c7b\u7533\u8bf7\u603b\u6570\u7684\u5c06\u8fd1\u4e00\u534a\uff0848%\uff09\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u5305\u542b\u4f53\u5916BCS\u76f8\u5173\u7814\u7a76\u548c\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u768419\u4e2a\u7533\u8bf7\uff0c\u5176\u4e2d11\u4e2aANDAs\u5df2\u5ba1\u8bc4\u5b8c\uff0c\u53ea\u67091\u4e2aANDA\uff08\u5360\u5df2\u5ba1\u8bc4\u603b\u7533\u8bf7\u76849%\uff09\u5305\u542b\u5b8c\u6574\u3001\u5408\u9002\u7684BCS\u76f8\u5173\u4fe1\u606f\u4e14\u80fd\u5728\u4e00\u4e2a\u5ba1\u8bc4\u5468\u671f\u5185\u5b8c\u6210BE\u90e8\u5206\u7684\u5ba1\u8bc4\u3002\u800c\u5176\u4ed610\u4e2aANDAs\u7ecf\u5386\u4e862~5\u4e2a\u5ba1\u8bc4\u5468\u671f\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4e0b\u9762\u8ba8\u8bba\u7684\u6848\u4f8b\u4e2d\u53ef\u4ee5\u627e\u5230\u4e0e\u5177\u6709\u4f53\u5185BE\u7814\u7a76\u7684\u836f\u7269\u5ba1\u8bc4\u5468\u671f\uff0848%\u5728\u7b2c\u4e00\u4e2a\u5ba1\u8bc4\u5468\u671f\u5185\u5373\u53ef\u63a5\u53d7\uff09\u76f8\u6bd4\u5927\u90e8\u5206\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u7533\u8bf7\u5ba1\u8bc4\u5468\u671f\uff08\u5728\u7b2c\u4e00\u4e2a\u5ba1\u8bc4\u5468\u671f\u5185\u53ef\u63a5\u53d7\u7684\u4e0d\u8db310%\uff09\u8f83\u957f\u7684\u90e8\u5206\u539f\u56e0\u3002\u6bcf\u4e2a\u6848\u4f8b\u90fd\u6d89\u53ca\u4e0d\u540c\u7684\u836f\u7269\u3002<span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4e0b\u9762\u7684\u6848\u4f8b\u7814\u7a76\u7a81\u51fa\u4e86\u5ba1\u8bc4\u4e0d\u540c\u7684ANDAs\u65f6\u53d1\u73b0\u7684\u4e3b\u8981\u95ee\u9898\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<section class=\"\" style=\"max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\n<h2 class=\"\" style=\"margin: 5px;padding-right: 10px;padding-left: 10px;font-weight: bold;max-width: 100%;border-left: 5px solid rgb(226, 86, 27);line-height: 32px;color: rgb(102, 102, 102);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: 14px;color: rgb(0, 82, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u6848\u4f8b1\uff1a<\/span><\/strong><\/h2>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u57fa\u4e8eBCS 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style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<h2 class=\"\" style=\"margin: 5px;padding-right: 10px;padding-left: 10px;font-weight: bold;max-width: 100%;border-left: 5px solid rgb(226, 86, 27);line-height: 32px;color: rgb(102, 102, 102);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: 14px;color: rgb(0, 82, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u6848\u4f8b2\uff1a<\/span><\/strong><\/h2>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u57fa\u4e8eBCS\u7684\u7ec6\u80de\u6bd2\u6027\u7684\u4eff\u5236\u836f\u7684BE\u8c41\u514d\u7533\u8bf7\uff0c\u7533\u8bf7\u4eba\u4ec5\u63d0\u4ea4\u4e86\u4f53\u5916\u6eb6\u51fa\u6570\u636e\u652f\u6301BE\u8c41\u514d\u7533\u8bf7\u3002\u7533\u8bf7\u4eba\u4ec5\u9760\u5df2\u53d1\u8868\u7684\u6587\u732e\u652f\u6301\u836f\u7269\u5177\u6709\u9ad8\u6eb6\u89e3\u6027\u548c\u9ad8\u6e17\u900f\u6027\uff0c\u800c\u672a\u8fdb\u884c\u6eb6\u89e3\u6027\u548c\u6e17\u900f\u6027\u7814\u7a76\u3002\u5ba1\u8bc4\u4e2d\u5fc3\u4e0d\u63a5\u53d7\u91c7\u7528\u5df2\u53d1\u8868\u7684\u6587\u732e\u4f5c\u4e3a\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u8bc1\u636e\u7684\u7533\u8bf7\u3002\u6587\u732e\u4e2d\u53ef\u80fd\u4e0d\u542b\u6d4b\u8bd5\u673a\u6784\u5bf9\u7814\u7a76\u505a\u51fa\u5224\u65ad\u7684\u5fc5\u8981\u7ec6\u8282\uff0c\u800c\u65e0\u6cd5\u9a8c\u8bc1\u540c\u884c\u7684\u6587\u732e\uff0c\u56e0\u6b64\u5ba1\u8bc4\u4e2d\u5fc3\u5efa\u8bae\u7533\u8bf7\u4eba\u63d0\u4f9b\u6eb6\u89e3\u6027\u548c\u6e17\u900f\u6027\u7684\u7814\u7a76\u6570\u636e\uff0c\u8be6\u89c1CDER\u5de5\u4e1a\u6307\u5357\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<h2 class=\"\" style=\"margin: 5px;padding-right: 10px;padding-left: 10px;font-weight: bold;max-width: 100%;border-left: 5px solid rgb(226, 86, 27);line-height: 32px;color: rgb(102, 102, 102);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: 14px;color: rgb(0, 82, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u6848\u4f8b3\uff1a<\/span><\/strong><\/h2>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u7533\u8bf7\u4eba\u5f15\u7528\u4e86RLD\u6807\u7b7e\u4e2d\u7684\u4fe1\u606f\u4f5c\u4e3a\u9ad8\u6e17\u900f\u6027\u7684\u8bc1\u636e\uff0c\u4e14\u63d0\u4ea4\u4e86\u4f53\u5916\u8bd5\u9a8c\u6570\u636e\u652f\u6301\u8be5\u836f\u4e3a\u9ad8\u6eb6\u89e3\u6027\u548c\u836f\u54c1\u5feb\u901f\u6eb6\u51fa\u3002\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u663e\u793a\u8be5\u836f\u5728\u80c3\u80a0\u9053\u7684\u67d0\u4e9bpH\u6761\u4ef6\u4e0b\u4e0d\u7a33\u5b9a\u3002\u4e3a\u4e86\u8fbe\u5230\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u7684\u76ee\u7684\uff0cFDA\u8ba4\u4e3a\u836f\u7269\u4f53\u5916\u6570\u636e\u8bc1\u660e\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d\u7a33\u5b9a\u4e14\u836f\u7269\u5728\u4eba\u4f53\u7684\u5438\u6536\u7387\u81f3\u5c11\u8fbe\u523090%\uff0c\u5219\u53ef\u8ba4\u4e3a\u8be5\u836f\u5177\u6709\u9ad8\u6e17\u900f\u6027\u3002\u5ba1\u8bc4\u4e2d\u5fc3\u8ba4\u4e3a\u867d\u7136\u836f\u7269\u5728\u80c3\u80a0\u9053\u67d0\u4e00pH\u503c\u65f6\u4e0d\u7a33\u5b9a\uff0c\u4f46\u7533\u8bf7\u4eba\u672a\u5728\u63d0\u4ea4\u7684\u6587\u4ef6\u4e2d\u63d0\u4f9b\u8bc1\u636e\u8bc1\u660e\u7b26\u5408\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u7684\u8981\u6c42\u3002<\/span><\/p>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4e3a\u4e86\u83b7\u5f97\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u8d44\u683c\uff0c\u5ba1\u8bc4\u4e2d\u5fc3\u9700\u8981\u5ba1\u8bc4\u836f\u54c1\u5728\u80c3\u80a0\u9053\u4e2d\u4e0d\u540cpH\u73af\u5883\u4e2d\u662f\u5426\u80fd\u5feb\u901f\u6eb6\u51fa\u3002\u6b64\u65f6\uff0c\u7533\u8bf7\u4eba\u63d0\u4f9b\u5728\u591a\u79cd\u6eb6\u51fa\u4ecb\u8d28\uff080.1 N 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1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u9664\u4e86\u4e0a\u8ff0\u6848\u4f8b\u4e2d\u8ba8\u8bba\u7684\u4e3b\u8981\u7f3a\u9677\u4e4b\u5916\uff0c\u8fd8\u5728\u8fd9\u4e9b\u6848\u4f8b\u4e2d\u53d1\u73b0\u4e86\u5176\u4ed6\u5e38\u89c1\u7684\u7f3a\u9677\u3002\u8fd9\u4e9b\u7f3a\u9677\u4e3b\u8981\u4e0e\u63d0\u4ea4\u7684\u8d44\u6599\u4e0d\u5b8c\u6574\u6709\u5173\uff0c\u5982\u679c\u591a\u52a0\u6ce8\u610f\u5c31\u53ef\u4ee5\u907f\u514d\u8fd9\u4e9b\u7f3a\u9677\u3002\u6309\u7167\u7814\u7a76\u7c7b\u578b\u5206\u7c7b\uff0c\u5c06\u8fd9\u4e9b\u7f3a\u9677\u603b\u7ed3\u5728\u88681\u4e2d\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><img class=\"\"      style=\"border-width: 1px;border-style: solid;border-color: rgb(238, 237, 235);background-color: rgb(238, 237, 235);background-size: 22px;background-position: 50% 50%;background-repeat: no-repeat;box-sizing: border-box !important;overflow-wrap: break-word !important;width: 670px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/5-1558080840.jpg\" alt=\"FDA\u5bf9\u6297\u80bf\u7624\u4eff\u5236\u836fBE\u8c41\u514d\u7684\u89c2\u70b9\u53ca\u6848\u4f8b\u5206\u6790\" title=\"FDA\u5bf9\u6297\u80bf\u7624\u4eff\u5236\u836fBE\u8c41\u514d\u7684\u89c2\u70b9\u53ca\u6848\u4f8b\u5206\u6790\"  \/><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u4ee5\u4e0a\u4e09\u4e2a\u6848\u4f8b\u53cd\u6620\u4e86\u57fa\u4e8eBCS\u7684BE\u8c41\u514d\u7533\u8bf7\u4e0eANDA\u7533\u8bf7\u4e00\u8d77\u63d0\u4ea4\u65f6\u53cd\u590d\u51fa\u73b0\u7684\u95ee\u9898\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u867d\u7136\u8fd9\u4e9b\u6848\u4f8b\u7814\u7a76\u4e2d\u7684\u95ee\u9898\u662f\u5728\u5bf9\u6297\u80bf\u7624\u836f\u7269\u7684\u5ba1\u8bc4\u65f6\u53d1\u73b0\u7684\uff0c\u4f46\u662fOGD\u7684\u7ecf\u9a8c\u8868\u660e\u8fd9\u4e9b\u95ee\u9898\u4e0d\u53ea\u51fa\u73b0\u5728\u7279\u5b9a\u7684\u67d0\u4e00\u7c7b\u836f\u7269\u4e2d\uff0c\u4e00\u822c\u9002\u7528\u4e8e\u5c06\u4f53\u5916\u6e17\u900f\u6027\u3001\u6eb6\u89e3\u6027\u548c\u6eb6\u51fa\u66f2\u7ebf\u6d4b\u8bd5\u5e94\u7528\u5230\u57fa\u4e8eBCS 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\/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u76f8\u6bd4\u4e4b\u4e0b\uff0c<span style=\"max-width: 100%;color: rgb(255, 76, 0);box-sizing: border-box !important;overflow-wrap: break-word 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normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><span style=\"max-width: 100%;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%;color: rgb(255, 41, 65);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\uff082\uff09\u5242\u91cf\u9009\u62e9<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: 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!important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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%;color: rgb(255, 41, 65);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\uff083\uff09\u7ed9\u836f\u65b9\u6848\u3001\u91c7\u6837\u65f6\u95f4\u548c\u6e05\u9664\u671f<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">&nbsp;<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u5728\u836f\u7269\u6807\u7b7e\u4e2d\u63cf\u8ff0\u7684\u6cbb\u7597\u6307\u5357\u5e94\u5bf9\u7ed9\u836f\u65b9\u6848\u63d0\u51fa\u5efa\u8bae\uff0c\u8fd8\u5e94\u8003\u8651\u836f\u7269\u7684\u6d88\u9664\u901f\u7387\u548c\u534a\u8870\u671f\u7b49\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u4ee5\u786e\u4fdd\u9009\u62e9\u5408\u9002\u7684\u91c7\u6837\u65f6\u95f4\u548c\u6e05\u9664\u671f\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box 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style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);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%;color: rgb(255, 41, 65);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\uff085\uff09\u5408\u7528\u836f\u7269<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word 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255);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%;color: rgb(255, 41, 65);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\uff086\uff09\u7edf\u8ba1\u5b66\u8003\u8651<\/span><\/strong><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 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!important;\">\u7ecf\u9a8c\u8868\u660e\uff0c\u5728\u4e00\u4e2a\u5ba1\u67e5\u671f\u5185\uff0c\u5927\u591a\u6570\u975e\u57fa\u4e8eBCS\u7684ANDAs\u7684BE\u7814\u7a76\u8db3\u591f\u5145\u5206\uff0c\u8fd9\u4e9bANDAs\u7684\u5ba1\u6279\u65f6\u95f4\u8f83\u77ed\uff08\u63d0\u4ea4ANDAs\u4e4b\u524d\u548cBio-INDs\u7684\u65f6\u95f4\u4e5f\u8003\u7387\u5728\u5185\uff09\u3002<\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<h2 class=\"\" style=\"padding-top: 5px;padding-bottom: 5px;font-weight: bold;max-width: 100%;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;white-space: normal;widows: 1;line-height: 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break-word !important;\">5<\/span>\u58f0\u660e<\/h2>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 27.2px;white-space: normal;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;overflow-wrap: break-word !important;\">\u672c\u6587\u4e3a\u4f5c\u8005\u4e2a\u4eba\u89c2\u70b9\uff0c\u4e0d\u4ee3\u8868FDA\u7684\u5b98\u65b9\u89c2\u70b9\u548c\u653f\u7b56\u3002<br style=\"max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word !important;\"  \/><\/p>\n<p><br  \/><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6765\u6e90\uff1a 1\u5f15\u8a00&nbsp; \u4eff\u5236\u836f\u6d3b\u6027\u6210\u5206\u7684\u5438\u6536\u901f\u7387\u548c\u7a0b\u5ea6\u4e0e\u53c2\u6bd4\u5236\u5242\u76f8\u540c\u5219\u4e24\u79cd\u836f\u54c1\u662f\u751f\u7269\u7b49\u6548\u7684\uff0821 CFR  [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":98318,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98317"}],"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=98317"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98317\/revisions"}],"predecessor-version":[{"id":98321,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98317\/revisions\/98321"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/98318"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=98317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=98317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=98317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}