{"id":20644,"date":"2018-07-23T01:00:00","date_gmt":"2018-08-08T01:20:26","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/08\/eca%e6%96%b0%e9%97%bb%ef%bc%9a%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e4%bf%ae%e8%ae%a2%e5%90%8efda%e6%8c%87%e5%8d%97\/"},"modified":"2018-08-08T09:20:27","modified_gmt":"2018-08-08T01:20:27","slug":"eca%e6%96%b0%e9%97%bb%ef%bc%9a%e5%88%86%e6%9e%90%e6%96%b9%e6%b3%95%e9%aa%8c%e8%af%81%e4%bf%ae%e8%ae%a2%e5%90%8efda%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/20644\/","title":{"rendered":"ECA\u65b0\u95fb\uff1a\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u4fee\u8ba2\u540eFDA\u6307\u5357"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><span style=\"font-size: 15px;color: rgb(0, 82, 255);\">\u7ffb\u8bd1\uff1aJULIA&nbsp;\u6765\u6e90\uff1a<\/span><span style=\"font-size: 15px;color: rgb(0, 82, 255);\">Julia\u6cd5\u89c4\u7ffb\u8bd1<\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 13px;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\">1<\/span><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">8.07.2018<\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;text-align: center;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\">Revised FDA Guidance on the validation of analyticalmethods<\/span><\/strong><\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;text-align: center;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u4fee\u8ba2\u540e<\/span><\/strong><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><\/strong><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6307\u5357<\/span><\/strong><\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\">The FDA has recently published the final version of their&nbsp;<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: blue;box-sizing: border-box !important;word-wrap: break-word !important;\">Guidance for Industry &#8220;Bioanalytical Method Validation&#8221;.<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\">&nbsp;Extensive changes had been made to the&nbsp;<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: blue;box-sizing: border-box !important;word-wrap: break-word !important;\">guidance draft from 2013<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;\">; these are the most important:<\/span><\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u6700\u8fd1\u53d1\u5e03\u4e86\u884c\u4e1a\u6307\u5357\u201c\u751f\u7269\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u201d\u6700\u7ec8\u7248\u672c\u3002\u8be5\u7248\u672c\u5728<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">2013<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u57fa\u7840\u4e0a\u6709\u5927\u91cf\u4fee\u6539\uff0c\u4ee5\u4e0b\u70b9\u6700\u4e3a\u91cd\u8981\uff1a<\/span><\/span><\/p>\n<ul class=\"list-paddingleft-2\" type=\"disc\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">Chapter III, formerly &#8220;Chromatographic Methods&#8221;, has been renamed to &#8220;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">Bioanalytical method development and validation<\/strong>&#8221; and supplemented by subsection &#8220;Bioanalytical Parameters of CCs und LBAs&#8221;, which describes a total of nine parameters.<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u7b2c<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">III<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u7ae0\uff0c\u4e4b\u524d\u7684\u201c\u8272\u8c31\u65b9\u6cd5\u201d\u6539\u540d\u4e3a\u201c\u751f\u7269\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u548c\u9a8c\u8bc1\u201d\uff0c\u5e76\u8865\u5145\u4e86\u5b50\u90e8\u201c<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">CC<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u548c<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">LBA<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u7684\u751f\u7269\u5206\u6790\u53c2\u6570\u201d\uff0c\u5176\u4e2d\u63cf\u8ff0\u4e86\u603b\u5171<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">9<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u4e2a\u53c2\u6570\u3002<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">Chapter IV carries the title &#8220;Incurred Sample Reanalysis&#8221; (ISR) and, compared to the guidance draft of 2013 (here in chapter V), contains different requirements on how analyses must be repeated in order to verify the original analytical data. For example, samples for repeat analyses may not be pooled. Also, an ISR is expected for all studies submitted in the&nbsp; scope of an NDA, BLA or ANDA.<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u7b2c<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">IV<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u7ae0\u6807\u9898\u4e3a\u201c\u8bd5\u9a8c\u6837\u54c1\u518d\u5206\u6790\u201d\uff08<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">ISR<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\uff09\u4ee5\u53ca\u76f8\u6bd4\u4e8e<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">2013<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u5e74\u6307\u5357\u8349\u6848\uff08\u8fd9\u91cc\u662f\u5728\u7b2c<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">V<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u7ae0\uff09\uff0c\u5176\u4e2d\u5bf9\u4e3a\u4e86\u786e\u8ba4\u539f\u59cb\u5206\u6790\u6570\u636e\u800c\u5fc5\u987b\u91cd\u590d\u7684\u5206\u6790\u7684\u8981\u6c42\u662f\u4e0d\u540c\u7684\u3002\u4f8b\u5982\uff0c\u53ef\u80fd\u4e0d\u5171\u7528\u6837\u54c1\u7528\u4e8e\u518d\u5206\u6790\u3002\u8fd8\u6709\uff0c\u5728<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">NDA<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u3001<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">BLA<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u6216<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">ANDA<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u8303\u56f4\u5185\u63d0\u4ea4\u7684\u6240\u6709\u7814\u7a76\u90fd\u9700\u8981\u6709<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">ISR<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u3002<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">The tables included in the Annex have been completely revised and designed more clearly.<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u9644\u5f55\u4e2d\u6240\u5305\u62ec\u7684\u8868\u683c\u5df2\u5b8c\u5168\u4fee\u6539<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">,<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u5e76\u8bbe\u8ba1\u5f97\u66f4\u4e3a\u6e05\u6670<\/span><\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">The glossary has been expanded considerably and contains 31 new terms (from &#8220;Autosampler stability&#8221; and &#8220;Hook effect&#8221; to &#8220;Zero calibrator&#8221;).<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u672f\u8bed\u5df2\u589e\u52a0\u4e3a\u542b\u6709<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">31<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u4e2a\u65b0\u672f\u8bed<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">(<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: \u5b8b\u4f53;\">\u4ece\u201c\u81ea\u52a8\u53d6\u6837\u54c1\u7a33\u5b9a\u6027\u201d\u548c\u201c\u94a9\u72b6\u6548\u5e94\u201d\u81f3\u201c\u96f6\u70b9\u6821\u6b63\u201d<\/span><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-family: Arial, sans-serif;\">)<\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<ul class=\"list-paddingleft-2\" type=\"disc\" style=\"\"><br  \/><\/ul>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">Chapter II &#8220;Background&#8221; clearly points out theimportance of validated analytical methods, which are indispensable for thesuccessful execution of non-clinical, biopharmaceutical and clinical-pharmacological studies. These analytics offer critical data to&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">demonstrate the safety and efficacy of medicinal products<\/strong>. To ensure that this data iscompletely reliable, the FDA lays down the following key questions:<\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7b2c<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">II<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u7ae0\u201c\u80cc\u666f\u201d\u6e05\u6670\u5730\u6307\u51fa\u4e86\u9a8c\u8bc1\u5206\u6790\u65b9\u6cd5\u7684\u91cd\u8981\u6027\uff0c\u8fd9\u5bf9\u4e8e\u6210\u529f\u6267\u884c\u975e\u4e34\u5e8a\u3001\u751f\u7269\u836f\u54c1\u548c\u4e34\u5e8a\u836f\u54c1\u7814\u7a76\u662f\u4e0d\u53ef\u6216\u7f3a\u7684\u3002\u8fd9\u4e9b\u5206\u6790\u63d0\u4f9b\u4e86\u5173\u952e\u6570\u636e\u6765\u8bc1\u660e\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u4e3a\u4e86\u786e\u4fdd\u8fd9\u4e9b\u6570\u636e\u7684\u5b8c\u6574\u53ef\u9760\uff0c<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u8ba2\u51fa\u4e86\u4ee5\u4e0b\u5173\u952e\u95ee\u9898\uff1a<\/span><\/span><\/p>\n<ul class=\"list-paddingleft-2\" type=\"disc\" style=\"\">\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">Is the analyte being&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">specifically<\/strong>&nbsp;and&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">selectively<\/strong>&nbsp;captured by the method? Are there any interfering factors?<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">\u65b9\u6cd5\u5bf9\u5206\u6790\u7269\u662f\u5426\u5177\u6709\u4e13\u5c5e\u6027\u548c\u9009\u62e9\u6027\uff1f\u662f\u5426\u6709\u5e72\u6270\u56e0\u7d20\uff1f<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">What variabilities are to be expected? How&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">accurate<\/strong>&nbsp;and&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">precise&nbsp;<\/strong>is the procedure?<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">\u9884\u671f\u6709\u54ea\u4e9b\u6ce2\u52a8\u6027\uff1f\u7a0b\u5e8f\u7684\u51c6\u786e\u6027\u548c\u7cbe\u5bc6\u5ea6\u5982\u4f55\uff1f<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">What range in measurements provides reliable data? How sensitive is the method (detection and determination limits)?<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">\u5728\u4ec0\u4e48\u6d4b\u91cf\u8303\u56f4\u5185\u4f1a\u63d0\u4f9b\u53ef\u9760\u6570\u636e\uff1f\u65b9\u6cd5\u7075\u654f\u5ea6\u5982\u4f55\uff08\u68c0\u51fa\u9650\u548c\u5b9a\u91cf\u9650\uff09\uff1f<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">How do the collection, handling and storage of a sample affect the reliability of the data? What steps need to be followed while collecting samples? Must samples be frozen before they are shipped? Storage time and temperature of samples?<\/span><\/p>\n<\/li>\n<li>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">\u6837\u54c1\u91c7\u96c6\u3001\u5904\u7406\u548c\u5b58\u8d2e\u662f\u5982\u4f55\u5f71\u54cd\u6570\u636e\u53ef\u9760\u6027\u7684\uff1f\u5728\u91c7\u96c6\u6837\u54c1\u65f6\u6b65\u9aa4\u5982\u4f55\uff1f\u6837\u54c1\u5728\u8fd0\u9001\u4e4b\u524d\u662f\u5426\u5fc5\u987b\u51b7\u51bb\uff1f\u6837\u54c1\u7684\u5b58\u8d2e\u65f6\u957f\u548c\u6e29\u5ea6\u5982\u4f55\uff1f<\/span><\/p>\n<\/li>\n<\/ul>\n<ul class=\"list-paddingleft-2\" type=\"disc\" style=\"\"><br  \/><\/ul>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">The FDA expects that these questions are considered for proving the reliability of analytical data through&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">method validation<\/strong>.<\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">FDA<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u8981\u6c42\u901a\u8fc7\u65b9\u6cd5\u9a8c\u8bc1\u8bc1\u660e\u5206\u6790\u6570\u636e\u53ef\u9760\u6027\u65f6\u8003\u8651\u8fd9\u4e9b\u95ee\u9898\u3002<\/span><\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\"><br  \/><\/span><\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-family: Arial, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;font-size: 15px;\">Following the&nbsp;<strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">fit-for-purpose (FFP) concept<\/strong>&nbsp;however,the proportionality should be considered: compared to analytical studies, whichare paramount for gaining a marketing authorisation for a drug product,exploratory studies (e.g. in early stages of development) do not require a complete method validation in consideration of all key questions formulated in this guideline.<\/span><\/p>\n<p style=\"margin-bottom: 8px;max-width: 100%;min-height: 1em;line-height: normal;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\u5728\u9002\u5408\u76ee\u7684\uff08<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: Arial, sans-serif;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">FFP<\/span><span style=\"font-size: 15px;max-width: 100%;font-family: \u5b8b\u4f53;color: rgb(0, 0, 204);box-sizing: border-box !important;word-wrap: break-word !important;\">\uff09\u6982\u5ff5\u4e4b\u4e0b\uff0c\u4ecd\u5e94\u8003\u8651\u5747\u8861\u6027\uff1a\u76f8\u6bd4\u4e8e\u5206\u6790\u7814\u7a76\uff0c\u5bf9\u4e8e\u4e00\u4e2a\u836f\u54c1\u6765\u8bf4\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u662f\u81f3\u9ad8\u65e0\u4e0a\u7684\uff0c\u8003\u8651\u5230\u5728\u672c\u6307\u5357\u4e2d\u9610\u8ff0\u7684\u6240\u6709\u5173\u952e\u95ee\u9898\uff0c\u63a2\u7d22\u6027\u7814\u7a76\uff08\u4f8b\u5982\uff0c\u5728\u5f00\u53d1\u65e9\u671f\uff09\u5e76\u4e0d\u9700\u8981\u6709\u4e00\u4e2a\u5b8c\u6574\u7684\u65b9\u6cd5\u9a8c\u8bc1\u3002<\/span><\/span><\/p>\n<p><img class=\"\"       style=\"line-height: 25.6000003814697px;white-space: normal;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/08\/beepress0-1533691226.jpeg\" alt=\"ECA\u65b0\u95fb\uff1a\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u4fee\u8ba2\u540eFDA\u6307\u5357\" title=\"ECA\u65b0\u95fb\uff1a\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u4fee\u8ba2\u540eFDA\u6307\u5357\"  \/><\/p>\n<blockquote class='keep-source'>\n<p>\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a                         \u84b2\u516c\u82f1                      <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u7ffb\u8bd1\uff1aJULIA&nbsp;\u6765\u6e90\uff1aJulia\u6cd5\u89c4\u7ffb\u8bd1 18.07.2018 Revised FDA Guida [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":20645,"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\/20644"}],"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=20644"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/20644\/revisions"}],"predecessor-version":[{"id":20651,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/20644\/revisions\/20651"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/20645"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=20644"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=20644"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=20644"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}