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Q3B (R2); CPMP\/ICH\/2738\/99<\/strong>: \u65b0\u85ac\u4e2d\u306e\u4e0d\u7d14\u7269<\/li>\n<li><strong>ICH S4; CPMP\/ICH\/300\/95<\/strong>: \u52d5\u7269\uff08\u3052\u3063\u6b6f\u985e\u304a\u3088\u3073\u975e\u3052\u3063\u6b6f\u985e\uff09\u306b\u304a\u3051\u308b\u6162\u6027\u6bd2\u6027\u8a66\u9a13\u306e\u671f\u9593<\/li>\n<li><strong>ICH S7A; CPMP\/ICH\/539\/00<\/strong>: \u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u85ac\u7406\u7814\u7a76<\/li>\n<li><strong>ICH S7B; CPMP\/ICH\/423\/02<\/strong>: \u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306b\u304a\u3051\u308bQT\u9593\u9694\u5ef6\u9577\u30ea\u30b9\u30af\u306e\u975e\u81e8\u5e8a\u8a55\u4fa1<\/li>\n<li><strong>ICH S8; CHMP\/167235\/2004<\/strong>: \u30d2\u30c8\u533b\u85ac\u54c1\u306e\u514d\u75ab\u6bd2\u6027\u8a66\u9a13<\/li>\n<\/ul>\n<h4><strong>2025\u5e741\u670810\u65e5<\/strong><\/h4>\n<ul>\n<li><strong>ICH Q3A (R2); CPMP\/ICH\/2737\/99<\/strong>: \u65b0\u85ac\u539f\u85ac\u4e2d\u306e\u4e0d\u7d14\u7269<\/li>\n<li><strong>ICH Q5B; CPMP\/ICH\/139\/95<\/strong>: \u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u88fd\u54c1\u306e\u54c1\u8cea - \u7d30\u80de\u682a\u306b\u304a\u3051\u308b\u767a\u73fe\u69cb\u9020\u306e\u5206\u6790<\/li>\n<li><strong>ICH Q5D; CPMP\/ICH\/294\/95<\/strong>: \u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\/\u751f\u7269\u5b66\u7684\u88fd\u54c1\u306e\u305f\u3081\u306e\u7d30\u80de\u57fa\u8cea\u306e\u7279\u6027\u8a55\u4fa1<\/li>\n<li><strong>ICH Q6A; CPMP\/ICH\/367\/96<\/strong>: \u65b0\u533b\u85ac\u54c1\u304a\u3088\u3073\u65b0\u7269\u8cea\u306b\u542b\u307e\u308c\u308b\u5316\u5b66\u7269\u8cea\u306e\u898f\u683c<\/li>\n<li><strong>ICH Q6B; CPMP\/ICH\/365\/96<\/strong>: \u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u88fd\u54c1\/\u751f\u7269\u7531\u6765\u88fd\u54c1\u306e\u898f\u683c<\/li>\n<\/ul>\n<h4><strong>2025\u5e741\u67089\u65e5<\/strong><\/h4>\n<ul>\n<li><strong>EMA\/HMPC\/201116\/2005 Rev. 2; EMA\/CVMP\/814\/00 Rev.2<\/strong>: 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\u30d7\u30ed\u30bb\u30b9\u306b\u7d44\u307f\u8fbc\u3080\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u7a4d\u6975\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u3088\u308a\u3001TGA 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