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\n\uff0b\uff0b\uff0b \uff25\uff24\uff31\uff2d\uff1a\uff08European Directorate for the Quality of Medicines\uff1a\u6b27\u5dde\u533b\u85ac\u54c1\u54c1\u8cea\u7406\u4e8b\u4f1a\uff09\u6b27\u5dde\u5c40\u65b9\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u8a3c\u660e\u66f8\u3092\u767a\u884c\u3057\u3066\u3044\u308b\u516c\u7684\u6a5f\u95a2\u3067\u3001\u3053\u306e\u8a3c\u660e\u66f8\u304c\u6b27\u5dde\u3067\u306e\uff26\uff23\uff33\u4f7f\u7528\u306e\u5b89\u5168\u6027\u3092\u62c5\u4fdd\u3057\u3066\u3044\u308b <\/p>\n

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\n\uff21\uff1a \u7c73\u56fd\u7523\u30a6\u30b7\u7531\u6765\u539f\u6599\u3092\u4f7f\u7528\u3057\u305f\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u304a\u3088\u3073\u30a8\u30dd\u30b8\u30f3®\u6ce8\u3067\u3001\uff12\uff10\uff10\uff14\u5e74\uff11\uff10\u6708\uff11\u65e5\u4ee5\u964d\u306b\u51fa\u8377\u3055\u308c\u305f\u4e00\u90e8\u306e\u88fd\u54c1\u304c\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002 <\/p>\n

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\n\uff21\uff1a \uff12\uff10\uff10\uff14\u5e74\uff11\uff10\u6708\uff11\u65e5\u304b\u3089\uff12\uff10\uff10\uff16\u5e74\uff16\u6708\uff11\uff12\u65e5\u307e\u3067\u306e\u671f\u9593\u3067\u306f\u3001\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u304a\u3088\u3073\u30a8\u30dd\u30b8\u30f3®\u6ce8\u306e\u6295\u4e0e\u4f8b\u306b\u304a\u3044\u3066\u3001\u30af\u30ed\u30a4\u30c4\u30d5\u30a7\u30eb\u30c8\u30fb\u30e4\u30b3\u30d6\u75c5\u3092\u767a\u75c7\u3057\u305f\u3068\u3044\u3046\u5831\u544a\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u30a8\u30dd\u30b8\u30f3®\u6ce8\uff08\uff11\uff19\uff19\uff10\u5e74\uff09\u3001\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\uff08\uff11\uff19\uff19\uff11\u5e74\uff09\u767a\u58f2\u4ee5\u964d\u3001\uff12\uff10\uff10\uff14\u5e74\uff19\u6708\uff13\uff10\u65e5\u307e\u3067\u306e\u671f\u9593\u306b\u304a\u3044\u3066\u3082\u305d\u306e\u3088\u3046\u306a\u5831\u544a\u306f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002 <\/p>\n

\uff31\uff1a \u5065\u5eb7\u88ab\u5bb3\u306e\u6050\u308c\u304c\u304d\u308f\u3081\u3066\u5c11\u306a\u3044\u306e\u306b\u3001\u306a\u305c\u56de\u53ce\u3059\u308b\u306e\u3067\u3059\u304b\uff1f
\n\uff21\uff1a \u7c73\u56fd\u7523\u30a6\u30b7\u7531\u6765\u539f\u6599\u3092\u4f7f\u7528\u3057\u305f\u88fd\u54c1\u306f\u3001\u751f\u7269\u7531\u6765\u539f\u6599\u57fa\u6e96\u4e00\u90e8\u6539\u6b63\u6642\u306e\u7d4c\u904e\u63aa\u7f6e\u671f\u9593\u5185\uff08\uff12\uff10\uff10\uff14\u5e74\uff19\u6708\uff13\uff10\u65e5\u307e\u3067\uff09\u306b\u539f\u7523\u56fd\u306e\u5207\u308a\u66ff\u3048\u304c\u6c42\u3081\u3089\u308c\u3066\u304a\u308a\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\uff12\uff10\uff10\uff14\u5e74\uff11\uff10\u6708\uff11\u65e5\u4ee5\u964d\u306b\u51fa\u8377\u3055\u308c\u305f\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u304a\u3088\u3073\u30a8\u30dd\u30b8\u30f3®\u6ce8\u306e\u4e00\u90e8\u3067\u3001\u7c73\u56fd\u7523\u30a6\u30b7\u80ce\u4ed4\u8840\u6e05\uff08FCS\uff09\u3092\u4f7f\u7528\u3057\u3066\u57f9\u990a\u3057\u305f\u6709\u52b9\u6210\u5206\u304c\u4f7f\u308f\u308c\u3066\u3044\u305f\u3053\u3068\u304c\u5224\u660e\u3044\u305f\u3057\u307e\u3057\u305f\u306e\u3067\u3001\u8a72\u5f53\u88fd\u54c1\u3092\u81ea\u4e3b\u56de\u53ce\u3059\u308b\u3053\u3068\u306b\u3044\u305f\u3057\u307e\u3057\u305f\u3002 <\/p>\n

\uff31\uff1a FCS\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f\u307e\u305f\u3001\u4f55\u306e\u305f\u3081\u306b\u4f7f\u7528\u3057\u3066\u3044\u308b\u306e\u3067\u3059\u304b\uff1f
\n\uff21\uff1a FCS\u306f\u30a6\u30b7\u80ce\u4ed4\u8840\u6e05\uff08fetal calf serum\uff09\u306e\u3053\u3068\u3067\u3059\u3002\u6709\u52b9\u6210\u5206\u3092\u7d30\u80de\u304b\u3089\u7523\u751f\u3055\u305b\u308b\u305f\u3081\u306e\u57f9\u990a\u6db2\u4e2d\u306b\u3001\u6804\u990a\u7d20\uff08\u6210\u9577\u56e0\u5b50\uff09\u3092\u4f9b\u7d66\u3059\u308b\u305f\u3081\u306b\u52a0\u3048\u3066\u3044\u307e\u3059\u3002
\n\uff31\uff1a \u57f9\u990a\u6db2\u4e2d\u306b\u5165\u308c\u305fFCS\u306f\u305d\u306e\u307e\u307e\u88fd\u54c1\u306b\u5165\u308b\u306e\u3067\u3059\u304b\uff1f
\n\uff21\uff1a \u6709\u52b9\u6210\u5206\u3092\u7523\u751f\u3055\u305b\u305f\u57f9\u990a\u6db2\u306e\u7cbe\u88fd\u5de5\u7a0b\u3067FCS\u3084\u4ed6\u306e\u4e0d\u7d14\u7269\u306f\u5145\u5206\u306b\u9664\u53bb\u3055\u308c\u307e\u3059\u3002 <\/p>\n

\uff31\uff1a \u3044\u3064\u4e0d\u9069\u5207\u306a\u51fa\u8377\u304c\u3042\u308b\u3068\u308f\u304b\u3063\u305f\u306e\u3067\u3059\u304b\uff1f
\n\uff21\uff1a \uff12\uff10\uff10\uff16\u5e74\uff16\u6708\uff15\u65e5\u306b\u533b\u7642\u6a5f\u95a2\u3088\u308a\u3001\u300c\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u304a\u3088\u3073\u30a8\u30dd\u30b8\u30f3®\u6ce8\u306e\u30a6\u30b7\u7531\u6765\u6210\u5206\u306e\u751f\u7523\u56fd\u306f\u3044\u3064\u4f4e\u30ea\u30b9\u30af\u56fd\u7523\u306b\u5207\u308a\u66ff\u308f\u3063\u305f\u306e\u304b\uff1f\u300d\u3068\u306e\u304a\u554f\u3044\u5408\u308f\u305b\u3092\u53d7\u3051\u3001\u305d\u306e\u8abf\u67fb\u904e\u7a0b\u306b\u304a\u3044\u3066\u5224\u660e\u3044\u305f\u3057\u307e\u3057\u305f\u3002
\n\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u306f\uff16\u6708\uff19\u65e5\uff08\u91d1\uff09\u306b\u3001\u30a8\u30dd\u30b8\u30f3®\u6ce8\u306f\uff16\u6708\uff11\uff10\u65e5\uff08\u571f\uff09\u306b\u5224\u660e\u3057\u307e\u3057\u305f\u3002 <\/p>\n

\uff31\uff1a \u3069\u3046\u3057\u3066\u3053\u306e\u3088\u3046\u306a\u3053\u3068\u304c\u8d77\u3053\u3063\u305f\u306e\u3067\u3059\u304b\uff1f
\n\uff21\uff1a \uff12\uff10\uff10\uff13\u5e74\uff11\uff12\u6708\u306b\u5b9f\u65bd\u3057\u305f\u30a6\u30b7\u7531\u6765\u539f\u6599\u306e\u8abf\u67fb\u306b\u304a\u3044\u3066\u3001\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3\u304a\u3088\u3073\u30a8\u30dd\u30b8\u30f3\u6709\u52b9\u6210\u5206\u306e\u88fd\u9020\u904e\u7a0b\u3067\u4f7f\u7528\u3055\u308c\u308bFCS\u306e\u539f\u7523\u56fd\u8abf\u67fb\u3092\u884c\u3044\u307e\u3057\u305f\u3002\u305d\u306e\u969b\u306b\u8abf\u67fb\u306e\u904e\u7a0b\u3067\u4eba\u70ba\u7684\u30df\u30b9\u304c\u3042\u3063\u305f\u3053\u3068\u3001\u307e\u305f\u305d\u308c\u3092\u691c\u8a3c\u3059\u308b\u4f53\u5236\u304c\u4e0d\u5341\u5206\u3067\u3042\u3063\u305f\u3053\u3068\u304c\u539f\u56e0\u3067\u539f\u7523\u56fd\u3092\u8aa4\u8a8d\u3057\u3066\u3057\u307e\u3044\u307e\u3057\u305f\u3002
\n\uff31\uff1a \u3053\u308c\u304b\u3089\u6295\u4e0e\u3055\u308c\u308b\u88fd\u54c1\u306f\u5b89\u5168\u3067\u3059\u304b\uff1f
\n\uff21\uff1a \u533b\u7642\u6a5f\u95a2\u306b\u8a72\u5f53\u3059\u308b\u88fd\u54c1\u3092\u6848\u5185\u3057\u56de\u53ce\u4e2d\u3067\u3042\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u3053\u308c\u304b\u3089\u51fa\u8377\u3055\u308c\u308b\u88fd\u54c1\u306f\u3001\u3059\u3079\u3066\u4f4e\u30ea\u30b9\u30af\u56fd\u7523FCS\u3092\u57f9\u5730\u306b\u52a0\u3048\u3066\u88fd\u9020\u3057\u305f\u6709\u52b9\u6210\u5206\u3092\u88fd\u5264\u5316\u3057\u305f\u88fd\u54c1\u306b\u5207\u63db\u3048\u3066\u3044\u308b\u3053\u3068\u304b\u3089\u5b89\u5168\u3067\u3059\u3002 <\/p>\n

\uff31\uff1a \u518d\u767a\u9632\u6b62\u7b56\u3092\u6559\u3048\u3066\u304f\u3060\u3055\u3044\u3002
\n\uff21\uff1a \u73fe\u5728\u306e\u30c1\u30a7\u30c3\u30af\u4f53\u5236\u3092\u898b\u76f4\u3057\u3001\u8907\u6570\u90e8\u9580\u306b\u3088\u308b\u30c1\u30a7\u30c3\u30af\u4f53\u5236\u3092\u3088\u308a\u5f37\u5316\u3057\u3066\u307e\u3044\u308a\u307e\u3059\u3002\u306a\u304a\u3001\u3059\u3067\u306b\u7c73\u56fd\u7523FCS\u306e\u8cfc\u5165\u306f\u884c\u3063\u3066\u304a\u308a\u307e\u305b\u3093\u3002 <\/p>\n

———————————————————————-<\/p>\n

\uff12\uff10\uff10\uff16\u5e74\uff19\u6708 \u60a3\u8005\u69d8\u3078 <\/p>\n

\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u3001\u30a8\u30dd\u30b8\u30f3®\u6ce8\u81ea\u4e3b\u56de\u53ce\u306b\u3064\u3044\u3066\u306e\u304a\u8a6b\u3073\u3068\u3054\u5831\u544a<\/p>\n

\u3053\u306e\u5ea6\u306e\u30ce\u30a4\u30c8\u30ed\u30b8\u30f3®\u6ce8\u53ca\u3073\u30a8\u30dd\u30b8\u30f3®\u6ce8\u306e\u81ea\u4e3b\u56de\u53ce\u306b\u304a\u304d\u307e\u3057\u3066\u306f\u3001\u60a3\u8005\u69d8\u306b\u306f\u591a\u5927\u306a\u3054\u8ff7\u60d1\u3068\u3054\u5fc3\u914d\u3092\u304a\u639b\u3051\u3044\u305f\u3057\u307e\u3057\u305f\u3053\u3068\u3092\u6df1\u304f\u53cd\u7701\u3057\u3001\u8877\u5fc3\u3088\u308a\u304a\u8a6b\u3073\u7533\u3057\u4e0a\u3052\u307e\u3059\u3002
\n\u672c\u4ef6\u306b\u3064\u304d\u307e\u3057\u3066\u306f\u3001\u76e3\u7763\u5b98\u5e81\u3067\u3042\u308b\u6771\u4eac\u90fd\u306b\u56de\u53ce\u7d42\u4e86\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u3001\uff18\u6708\uff12\uff14\u65e5\u306b\u53d7\u7406\u3044\u305f\u3060\u304d\u307e\u3057\u305f\u3053\u3068\u3092\u3054\u5831\u544a\u7533\u3057\u4e0a\u3052\u307e\u3059\u3002<\/p>\n

\u4eca\u56de\u306e\u81ea\u4e3b\u56de\u53ce\u306f\u3001\uff12\uff10\uff10\uff13\u5e74\uff11\uff12\u6708\u7c73\u56fd\u3067\u306eBSE\u767a\u751f\u306b\u4f34\u3046\u30a6\u30b7\u80ce\u4ed4\u8840\u6e05\uff08FCS\uff09\u306e\u539f\u7523\u56fd\u8abf\u67fb\u306b\u304a\u3044\u3066\u3001\u4e00\u90e8\u306e\u539f\u85ac\u306b\u3064\u3044\u3066\u7c73\u56fd\u7523FCS\u4f7f\u7528\u3068\u3059\u3079\u304d\u3068\u3053\u308d\u3092\u8c6a\u5dde\u7523FCS\u4f7f\u7528\u3068\u8aa4\u3063\u3066\u8a18\u8f09\u3057\u3001\u56fd\u304c\u5b9a\u3081\u305f\u7c73\u56fd\u7523FCS\u306e\u4f7f\u7528\u53ef\u80fd\u306a\u671f\u9650\u7d42\u4e86\u5f8c\u3082\u3001\u305d\u306e\u539f\u85ac\u3092\u4f7f\u7528\u3057\u305f\u88fd\u54c1\u3092\u88fd\u9020\u51fa\u8377\u3057\u3066\u3044\u305f\u3053\u3068\u306b\u3088\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n

\u3053\u306e\u4e8b\u614b\u306b\u5bfe\u3057\u3001\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u53ca\u3073\u539a\u751f\u52b4\u50cd\u7701\u306b\u3088\u308b\u7acb\u5165\u308a\u8abf\u67fb\u3092\u53d7\u3051\u3001\u751f\u7269\u7531\u6765\u539f\u6599\u306e\u53d6\u308a\u6271\u3044\u306b\u95a2\u3059\u308b\u6539\u5584\u7b56\u3092\u63d0\u51fa\u3057\u53d7\u7406\u3044\u305f\u3060\u3044\u3066\u304a\u308a\u307e\u3059\u3002
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