{"id":417,"date":"2023-08-25T13:59:15","date_gmt":"2023-08-25T05:59:15","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=417"},"modified":"2024-01-18T09:57:21","modified_gmt":"2024-01-18T01:57:21","slug":"nmpa-announcement-on-adopting-ich-guidelines-m10-qas-and-faqs","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/nmpa-ich%e3%82%ac%e3%82%a4%e3%83%89%e3%83%a9%e3%82%a4%e3%83%b3-m10-qas-and-faq%e3%81%ae%e6%8e%a1%e7%94%a8%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e3%81%8a%e7%9f%a5%e3%82%89%e3%81%9b\/","title":{"rendered":"ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3M10 Q&amp;A\u304a\u3088\u3073FAQ\u306e\u63a1\u7528\u306b\u95a2\u3059\u308bNMPA\u304b\u3089\u306e\u304a\u77e5\u3089\u305b"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u00a0 \u00a0 \u00a0 \u533b\u85ac\u54c1\u767b\u9332\u306b\u95a2\u3059\u308b\u6280\u8853\u57fa\u6e96\u3092\u56fd\u969b\u7684\u306a\u57fa\u6e96\u306b\u5408\u308f\u305b\u308b\u305f\u3081\u3001\u5be9\u8b70\u306e\u7d50\u679c\u3001ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3M10: Bioanalytical Method Validation And Study Sample Analysis(\u4ee5\u4e0b\u3001M10)\u306eQ&amp;A\u6587\u66f8\u53ca\u3073FAQ\u6587\u66f8\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3068\u3057\u305f\u3002\u3064\u304d\u307e\u3057\u3066\u306f\u3001\u4e0b\u8a18\u306e\u901a\u308a\u304a\u77e5\u3089\u305b\u3044\u305f\u3057\u307e\u3059\uff1a<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">1.2023\u5e747\u670829\u65e5\uff08\u751f\u7269\u5b66\u7684\u8a66\u6599\u5206\u6790\u306e\u6700\u521d\u306e\u8a18\u9332\u6642\u9593\u306b\u57fa\u3065\u304f\uff09\u4ee5\u964d\u306e\u95a2\u9023\u7814\u7a76\u306f\u3001M10\u306eQ&amp;A\u6587\u66f8\u304a\u3088\u3073FAQ\u6587\u66f8\u306b\u9069\u7528\u3055\u308c\u308b\u3002<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">2.\u5f53\u8a72\u6280\u8853\u6307\u91dd\u306f\u3001NMPA \u533b\u85ac\u54c1\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u304b\u3089\u95b2\u89a7\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002NMPA \u533b\u85ac\u54c1\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\u306f\u3001\u672c\u516c\u793a\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u6280\u8853\u6307\u5c0e\u3092\u884c\u3046\u3002<\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u56fd\u5bb6\u533b\u85ac\u54c1\u7ba1\u7406\u5c40<\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">2023\u5e746\u670829\u65e5<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u533b\u85ac\u54c1\u767b\u9332\u306b\u95a2\u3059\u308b\u6280\u8853\u57fa\u6e96\u3092\u56fd\u969b\u7684\u306a\u57fa\u6e96\u306b\u5408\u308f\u305b\u308b\u305f\u3081\u3001\u5be9\u8b70\u306e\u7d50\u679c\u3001ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3M10: Bioanalytical Method Validation And Study Sample Analysis(\u4ee5\u4e0b\u3001M10)\u306eQ&amp;A\u6587\u66f8\u53ca\u3073FAQ\u6587\u66f8\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3068\u3057\u305f\u3002\u3064\u304d\u307e\u3057\u3066\u306f\u3001\u4e0b\u8a18\u306e\u901a\u308a\u304a\u77e5\u3089\u305b\u3044\u305f\u3057\u307e\u3059\uff1a<\/p>","protected":false},"author":4,"featured_media":418,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[70],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/417"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/comments?post=417"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/417\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/418"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=417"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/categories?post=417"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/tags?post=417"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}