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绗笁灞婂畾閲忚嵂鐞嗗涓庢柊鑽瘎浠峰浗闄呬細璁氱煡锛堢浜岃疆锛

鏉ユ簮锛氫腑鍥借嵂鐞嗗浼氱綉銆銆銆 銆瀛楀彿:[] [] []    鎵撳嵃
 

鑷粠缇庡浗FDA(2004)鎻愬嚭浜鍩轰簬妯″瀷鐨勮嵂鐗╃爺鍙(Model Based Drug DevelopmentMBDD)鈥妯″紡锛屽畾閲忚嵂鐞嗗鍦ㄥ叏鐞冭寖鍥村唴鎴涓轰竴涓儹闂ㄥ绉戯紝MBDD宸茬粡鍒楀叆涓浗鍗佷簩浜鍥藉绉戞妧閲嶅ぇ涓撻」鐮旂┒銆備腑鍥借嵂鐞嗗浼氭暟瀛﹁嵂鐞嗕笓涓氬鍛樹細鍒嗗埆浜2007骞村拰2010骞村湪鍗椾含鍜屽帵闂ㄦ垚鍔熶妇鍔炰簡涓ゅ眾瀹氶噺鑽悊瀛︿笌鏂拌嵂璇勪环鍥介檯瀛︽湳浼氳鈥(International Symposium of Quantitative Pharmacology in Drug Development and Regulation, ISQP)锛屽惛寮曚簡鍥藉唴澶栦紬澶氬鑰呭弬鍔犮備负淇冭繘鎴戝浗瀹氶噺鑽悊瀛︾殑鍙戝睍锛屽杩涘浗鍐呭浜ゆ祦锛岀涓夊眾瀹氶噺鑽悊瀛︿笌鏂拌嵂璇勪环鍥介檯瀛︽湳浼氳灏嗕簬2011113 - 6鏃ュ湪涓婃捣涓惧姙銆備細璁皢閭璇锋潵鑷編鍥姐佹娲层佷腑鍥界殑鑽斂褰撳眬銆佸鏈晫鍜屼紒涓氱晫绛夎澶氱煡鍚嶄笓瀹跺鑰呭弬鍔狅紝鏈浼氳灏嗕负鍥藉唴澶栦粠浜嬪畾閲忚嵂鐞嗗涓庢柊鑽爺绌朵汉鍛樻彁渚涗竴涓氦娴佸钩鍙帮紝娆㈣繋浠庝簨鐩稿叧鐮旂┒鐨勪汉鍛樺弬鍔狅紝璇︾粏浼氳閫氱煡瑙侀檮浠躲


绗笁灞婂畾閲忚嵂鐞嗗涓庢柊鑽瘎浠峰浗闄呬細璁氱煡锛堢浜岃疆锛.pdf

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