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\"\"\u30a2\u30f3\u30b1\u30fc\u30c8\u8abf\u67fb\u30b5\u30fc\u30d3\u30b9<\/b><\/a><\/figure>\u533b\u85ac\u54c1\u958b\u767a\u306e\u30d7\u30ec\u30ea\u30b5\u30fc\u30c1\u306a\u3069\u3001\u533b\u7642\u60c5\u5831\u3092\u542b\u3080\u767b\u9332\u30d1\u30cd\u30eb\u3092\u6d3b\u304b\u3057\u305f\u30a2\u30f3\u30b1\u30fc\u30c8\u8abf\u67fb\u3092\u884c\u3044\u307e\u3059\u3002\n<\/div>\n\n\n\n
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\"\"\u30d2\u30c8\u751f\u4f53\u8a66\u6599\u63d0\u4f9b\uff5c\u81e8\u5e8a\u7814\u7a76\u306e\u30d1\u30fc\u30c8\u30ca\u30fc<\/b><\/a><\/figure>ICH M10\u5bfe\u5fdc\u3001\u5165\u624b\u56f0\u96e3\u306a\u5e0c\u5c11\u75be\u60a3\u306e\u691c\u4f53\u3002\u5275\u85ac\u30fb\u8a3a\u65ad\u85ac\u958b\u767a\u3001\u5316\u7ca7\u54c1\u30fb\u98df\u54c1\u958b\u767a\u306e\u3042\u3089\u3086\u308b\u8ab2\u984c\u306b\u3002\u30ef\u30f3\u30b9\u30c8\u30c3\u30d7\u3067\u30b5\u30dd\u30fc\u30c8\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b5\u30fc\u30d3\u30b9<\/b><\/a><\/figure>\u6cbb\u9a13\u696d\u754c\u306740\u5e74\u306e\u5b9f\u7e3e\u306e\u3042\u308b\u30a4\u30f3\u30af\u30ed\u30e0\u304c\u3001\u7d4c\u9a13\u3092\u6d3b\u304b\u3057\u3066\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u9054\u6210\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\n<\/div>\n\n\n\n
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\"\"\u5927\u962a\u6cbb\u9a13\u75c5\u9662 \u30bb\u30f3\u30c8\u30e9\u30ebIRB\uff5c\u5c02\u4efb\u30b9\u30bf\u30c3\u30d5\u304c\u30d5\u30eb\u30b5\u30dd\u30fc\u30c8<\/b><\/a><\/figure>\u52b9\u7387\u7684\u3067\u8fc5\u901f\u306a\u5be9\u67fb\u3092\u3081\u3056\u3057\u3066\u3001\u5be9\u67fb\u624b\u7d9a\u304d\u304b\u3089\u6cbb\u9a13\u7d42\u4e86\u307e\u3067\u3001\u304d\u3081\u7d30\u304b\u3044\u30b5\u30dd\u30fc\u30c8\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u5973\u6027\u5bfe\u8c61\u306e\u6cbb\u9a13\u30fb\u81e8\u5e8a\u7814\u7a76<\/b><\/a><\/figure>\u7523\u79d1\u30fb\u5a66\u4eba\u79d1\u5c02\u9580\u533b\u3068\u306e\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306a\u3069\u3092\u6d3b\u304b\u3057\u3066\u3001\u5973\u6027\u5bfe\u8c61\u306e\u6cbb\u9a13\u30fb\u81e8\u5e8a\u7814\u7a76\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\n<\/div>\n\n\n\n
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\"\"\u80a5\u6e80\u75c7\u306e\u8a66\u9a13 \u6210\u529f\u306e\u79d8\u8a23\uff5c\u30b9\u30bf\u30c3\u30d5\u306e\u58f0<\/b><\/a><\/figure>\u751f\u6d3b\u7fd2\u6163\u75c5\u5206\u91ce\u306e\u8a66\u9a13\u304c\u5f97\u610f\u306a\u30a4\u30f3\u30af\u30ed\u30e0\u3002\u8a66\u9a13\u3092\u6210\u529f\u306b\u5c0e\u304f\u79d8\u8a23\u3092\u30b9\u30bf\u30c3\u30d5\u304c\u8a9e\u308a\u307e\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u80a5\u6e80\u75c7\u306e\u8a66\u9a13 \u6210\u529f\u306e\u79d8\u8a23\uff5c\u30dc\u30e9\u30f3\u30c6\u30a3\u30a2\u306e\u58f0<\/b><\/a><\/figure>\u80a5\u6e80\u75c7\u60a3\u8005\u5bfe\u8c61\u8a66\u9a13\u306e\u53c2\u52a0\u8005\u306b\u30a4\u30f3\u30bf\u30d3\u30e5\u30fc\u3002\u8a66\u9a13\u3092\u6210\u529f\u306b\u5c0e\u304f\u79d8\u8a23\u3092\u3001\u53c2\u52a0\u8005\u306e\u58f0\u3092\u901a\u3057\u3066\u7d39\u4ecb\u3057\u307e\u3059\u3002\n<\/div>\n\n\n\n
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\"\"\u81e8\u5e8a\u8a66\u9a13\u30b3\u30f3\u30b7\u30a7\u30eb\u30b8\u30e5\u30b5\u30fc\u30d3\u30b9\uff5c\u30a4\u30f3\u30af\u30ed\u30e0<\/b><\/a><\/figure>40\u5e74\u306b\u308f\u305f\u308b\u6cbb\u9a13\u5b9f\u65bd\u652f\u63f4\u306e\u5b9f\u7e3e\u3092\u6d3b\u304b\u3057\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u306e\u7acb\u6848\u3084\u30d5\u30a3\u30b8\u30d3\u30ea\u30c6\u30a3\u8abf\u67fb\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u8a55\u4fa1\u8a66\u9a13\u30fb\u81e8\u5e8a\u7814\u7a76\uff5c\u88ab\u9a13\u8005\u30fb\u5834\u6240\u30fb\u30b9\u30bf\u30c3\u30d5\u304c\u5fc5\u8981\u306a\u3089<\/b><\/a><\/figure>\u7279\u5b9a\u306e\u6761\u4ef6\u304c\u3042\u308b\u88ab\u9a13\u8005\u96c6\u3081\u3084\u3001\u8a66\u9a13\u3084\u5b9f\u9a13\u306b\u9069\u3057\u305f\u4f1a\u5834\u63a2\u3057\u306a\u3069\u3001\u30a4\u30f3\u30af\u30ed\u30e0\u304c\u304a\u624b\u4f1d\u3044\u3044\u305f\u3057\u307e\u3059\u3002\n<\/div>\n\n\n\n
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\"\"\u96e3\u6613\u5ea6\u306e\u9ad8\u3044\u88ab\u9a13\u8005\u52df\u96c6\u6848\u4ef6\u306a\u3089\uff5c\u30a4\u30f3\u30af\u30ed\u30e0<\/b><\/a><\/figure>\u691c\u67fb\u5024\u6307\u5b9a\u306e\u88ab\u9a13\u8005\u96c6\u3081\u3084\u3001\u52df\u96c6\u671f\u9593\u304c\u77ed\u3044\u6848\u4ef6\u306a\u3069\u3001\u96e3\u6613\u5ea6\u306e\u9ad8\u3044\u6848\u4ef6\u306b\u3082\u5bfe\u5fdc\u3057\u307e\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u65e5\u672c\u3067\u884c\u3046\u5916\u56fd\u4eba\u306e\u6cbb\u9a13<\/b><\/a><\/figure>\u98df\u751f\u6d3b\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u914d\u616e\u304c\u5fc5\u8981\u306a\u5916\u56fd\u4eba\u5bfe\u8c61\u8a66\u9a13\u3002\u7d04200\u75c7\u4f8b\u306e\u5b9f\u7e3e\u304c\u3042\u308b\u30a4\u30f3\u30af\u30ed\u30e0\u306b\u304a\u4efb\u305b\u304f\u3060\u3055\u3044\u3002\n<\/div>\n\n\n\n
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\"\"\u4eba\u3092\u96c6\u3081\u308b\uff5c\u30a2\u30f3\u30b1\u30fc\u30c8\u30fb\u5546\u54c1\u30e2\u30cb\u30bf\u30fc\u30fb\u4f53\u9a13\u4f1a<\/b><\/a><\/figure>\u5546\u54c1\u30e2\u30cb\u30bf\u30fc\u3084\u4f53\u9a13\u4f1a\u306a\u3069\u306e\u53c2\u52a0\u8005\u96c6\u3081\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u5e74\u9f62\u3084\u75c7\u72b6\u306a\u3069\u3001\u6761\u4ef6\u304c\u3042\u308b\u5834\u5408\u306b\u3082\u5bfe\u5fdc\u3057\u307e\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"ICH M10\u306b\u5bfe\u5fdc\uff5c\u65e5\u672c\u4eba\u306e\u65b0\u9bae\u8840\u3092\u5b89\u5b9a\u4f9b\u7d66<\/b><\/a><\/figure>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\u3068\u8a08\u753b\u7684\u306a\u8a66\u6599\u306e\u5165\u624b\u3002\u6307\u5b9a\u306e\u65e5\u6642\u306b\u5fc5\u8981\u306a\u4f8b\u6570\u306e\u5b89\u5b9a\u4f9b\u7d66\u3067\u3001\u958b\u767a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u9045\u5ef6\u306e\u30ea\u30b9\u30af\u3092\u56de\u907f\u3002\n<\/div>\n\n\n\n
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\"\"\u5927\u898f\u6a21\u6cbb\u9a13\u306e\u5b9f\u65bd\u65bd\u8a2d\u3092\u304a\u63a2\u3057\u306a\u3089<\/b><\/a><\/figure>1,000\u75c7\u4f8b\u30ec\u30d9\u30eb\u306e\u8a66\u9a13\u306a\u3069\u3001\u5927\u898f\u6a21\u6cbb\u9a13\u3092\u30b5\u30dd\u30fc\u30c8\u3002\u6cbb\u9a13\u306b\u7279\u5316\u3057\u305f\u533b\u7642\u6a5f\u95a2\u3067\u3001\u4e00\u62ec\u5b9f\u65bd\u3082\u53ef\u80fd\u3067\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u773c\u79d1\u9818\u57df\u306e\u6cbb\u9a13\u3000\u5b9f\u65bd\u65bd\u8a2d\u3092\u304a\u63a2\u3057\u306a\u3089<\/b><\/a><\/figure>\u7dd1\u5185\u969c\u3084\u89d2\u819c\u75be\u60a3\u306a\u3069\u3001\u773c\u79d1\u9818\u57df\u306e\u6cbb\u9a13\u306a\u3089\u3001\u5e83\u57df\u306a\u773c\u79d1\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3092\u3082\u3064\u30a4\u30f3\u30af\u30ed\u30e0\u306b\u304a\u4efb\u305b\u304f\u3060\u3055\u3044\u3002\n<\/div>\n\n\n\n
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\"\"\u533b\u7642\u60c5\u5831\u306b\u7279\u5316\u3057\u305f\u88ab\u9a13\u8005\u52df\u96c6\uff5c\u5b66\u8853\u7814\u7a76\u30fb\u8a55\u4fa1\u8a66\u9a13\u306e\u7dcf\u5408\u652f\u63f4<\/b><\/a><\/figure>\u6cbb\u9a13\u306e\u30a4\u30f3\u30af\u30ed\u30e0\u304c\u3001\u5b66\u8853\u7814\u7a76\u3084\u8a55\u4fa1\u8a66\u9a13\u306e\u300c\u88ab\u9a13\u8005\u52df\u96c6\u300d\u300c\u5b9f\u65bd\u5834\u6240\u300d\u300c\u5b9f\u65bd\u30b9\u30bf\u30c3\u30d5\u300d\u300c\u533b\u7642\u884c\u70ba\u3092\u4f34\u3046\u300d\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u672a\u6210\u5e74\u5bfe\u8c61\u306e\u6cbb\u9a13\u3092\u304a\u8003\u3048\u306a\u3089\uff5c\u30a4\u30f3\u30af\u30ed\u30e0<\/b><\/a><\/figure>\u4e73\u5e7c\u5150\u304b\u3089\u9752\u5c11\u5e74\u3001\u5065\u5eb7\u30fb\u75be\u60a3\u30fb\u5927\u898f\u6a21\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u6761\u4ef6\u306e\u672a\u6210\u5e74\u306e\u88ab\u9a13\u8005\u52df\u96c6\u3082\u3001\u5b9f\u65bd\u65bd\u8a2d\u306e\u624b\u914d\u3082\u3002\u3042\u3089\u3086\u308b\u3054\u8981\u671b\u306b\u304a\u5fdc\u3048\u3057\u307e\u3059\u3002\n<\/div>\n\n\n\n
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\"\"\u9069\u683c\u75c7\u4f8b\u3092\u63a2\u3057\u5f53\u3066\u308b\u306e\u304c\u56f0\u96e3\u306a\u8a66\u9a13\u306b<\/b><\/a><\/figure>\u9078\u629e\u57fa\u6e96\u306b\u5408\u81f4\u3059\u308b\u60a3\u8005\u304c\u6570\uff05\u7a0b\u5ea6\u3001\u5927\u91cf\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u691c\u67fb\u304c\u5fc5\u8981\u2026\u2026\u5927\u898f\u6a21Pre\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306f\u3001\u30a4\u30f3\u30af\u30ed\u30e0\u306b\u304a\u4efb\u305b\u304f\u3060\u3055\u3044\u3002\n<\/div>\n<\/div>\n\n\n\n
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\"\"\u9ad8\u9f62\u8005\u5bfe\u8c61\u306e\u6cbb\u9a13\u30fb\u81e8\u5e8a\u7814\u7a76\u3092\u304a\u8003\u3048\u306a\u3089<\/b><\/a><\/figure>\u8001\u5316\u8981\u56e0\u306e\u75be\u60a3\u30fb\u75c7\u72b6\u306e\u3042\u308b\u9ad8\u9f62\u5c64\u306e\u88ab\u9a13\u8005\u52df\u96c6\u3001\u9577\u671f\u89b3\u5bdf\u3001\u5c02\u9580\u7684\u8a55\u4fa1\u65b9\u6cd5\u306a\u3069\u3001\u9ad8\u9f62\u8005\u5bfe\u8c61\u306e\u8a66\u9a13\u3092\u30a4\u30f3\u30af\u30ed\u30e0\u304c\u30d5\u30eb\u30b5\u30dd\u30fc\u30c8\u3002\n<\/div>\n\n\n\n
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