銆銆瀹夊叏钘ョ悊瀛革紙Safety pharmacology锛夋槸鏂拌棩鑷ㄥ簥鍓嶅畨鍏ㄦц⿻鍍归牁鍩熶腑涓鍊嬮噸瑕佺殑绲勬垚閮ㄥ垎锛岃繎骞翠締鎰堜締鎰堝彈鍒板悇鍦嬭棩鍝佺洠鐫g鐞嗙暥灞鍜屾柊钘ョ爺鐧间汉鍝$殑鏅亶闂滄敞銆侷CH浜 2001 骞 11鏈堢櫦甯冪殑鈥滀汉鐢ㄨ棩鍝佸畨鍏ㄨ棩鐞嗗鐮旂┒鎸囧崡锛圫7A锛夆 浣胯┎瀛哥寰楀埌浜嗗揩閫熺殑鐧煎睍锛2005 骞 10鏈 ICH 鍙堢櫦甯冧簡鈥滆⿻鍍逛汉鐢ㄨ棩鍝佹經鍦ㄧ坊蹇冨瑜囨サ鍖栧欢閬蹭綔鐢紙QT闁撴湡寤堕暦锛夌殑瀹夊叏钘ョ悊瀛哥爺绌讹紙S7B锛夆濄2014骞村湅瀹堕鍝佽棩鍝佺洠鐫g鐞嗙附灞钘ュ涓績鍐嶆绶婅窡鍦嬮殯锛屽墠娌夸慨瑷傚拰鐧煎竷浜嗏滆棩鐗╁畨鍏ㄨ棩鐞嗗鐮旂┒鎶琛撴寚灏庡師鍓団濆拰鈥滆棩鐗㏎T闁撴湡寤堕暦娼涘湪浣滅敤闈炶嚚搴婄爺绌舵妧琛撴寚灏庡師鍓団濓紝閫蹭竴姝ユ彁鍗囦簡瀹夊叏钘ョ悊瀛哥殑鐮旂┒瑕忕瘎鍜屾妧琛撹姹傘傜洰鍓嶅畨鍏ㄨ棩鐞嗗鐨勭爺绌惰秺渚嗚秺娣卞叆锛屾妧琛撴墜娈佃秺渚嗚秺鍏堥诧紝鈥滅涓夊眴锛2017骞达級涓湅瀹夊叏钘ョ悊瀛稿琛撳勾鏈冩毃绗叚灞嗗畨鍏ㄨ棩鐞嗗鍦嬮殯瀛歌鐮旇鏈冣濈偤绶婅窡鍦嬮殯瀹夊叏钘ョ悊瀛哥殑鐧煎睍锛屾彁楂樺湅鍐呰棩鐗╃爺绌跺柈浣嶉棞浜庡畨鍏ㄨ棩鐞嗗鐨勭爺绌舵按骞筹紝鍔犲挤瀹夊叏钘ョ悊瀛哥爺绌舵柟娉曠殑瑕忕瘎鍖栥佹爣婧栧寲锛屼績閫叉垜鍦嬪畨鍏ㄨ棩鐞嗗鐮旂┒瀛歌浜ゆ祦鎻愪緵鏈夌泭骞冲彴銆

銆銆鍖椾含寤f簮閬旂鎶鐧煎睍鏈夐檺鍏徃绺界稉鐞嗐绔犳牴鏈ㄥ厛鐢熶綔鐐哄ぇ鏈冪殑鍢夎硴鍋氬牨鍛婏紝浠嬬垂浜咵MKA澶у嫊鐗╃敓鐞嗕俊鍙烽仚娓郴绲辨渶鏂扮殑浣跨敤鍜岀爺绌剁殑閫插睍锛


涓銆佹渻璀颁富椤

鎶婃彙瀹夊叏钘ョ悊瀛哥爺绌跺叏鐞冪櫦灞曞嫊鍚戯紝鍏ㄩ潰鎻愬崌鎴戝湅瀹夊叏钘ョ悊瀛哥爺绌舵按骞炽

浜屻佹渻璀扮洰鐨

鐐烘垜鍦嬪畨鍏ㄨ棩鐞嗗宸ヤ綔鑰呮惌寤哄琛撲氦娴佸钩鍙帮紝鎻愪緵鑸囨渻鑰呭睍绀烘渶鏂扮爺绌剁祼鏋滅殑鑹锛屽姞寮锋キ鍐呯殑鍗斾綔鑸囨簼閫氾紝浜嗚В鍦嬪唴澶栧湪鏂拌棩瀹夊叏钘ョ悊瀛歌⿻鍍归牁鍩熺殑鏈鏂伴插睍锛屾彁楂樻垜鍦嬪畨鍏ㄨ棩鐞嗗鐮旂┒姘村钩銆

涓夈佹渻璀颁富瑕佷氦娴佺爺璁ㄥ唴瀹

锛堜竴锛夊畨鍏ㄨ棩鐞嗗鐨勬斂绛栬В璁鍙婂睍鏈涳紙CFDA锛夛紱

锛堜簩锛夊畨鍏ㄨ棩鐞嗗鐨勭暥鍓嶇爺绌剁啽榛烇紙鍙仛鐒︿簬鍠嬬郴绲遍茶娣卞叆鎺㈣锛夛紱

锛堜笁锛夊畨鍏ㄨ棩鐞嗗鏂版妧琛撴柊鏂规硶鐨勭爺绌跺拰鎳夌敤锛

锛堝洓锛夊畨鍏ㄨ棩鐞嗗涓殑鐢熺墿鏍囧織鐗╃爺绌讹紱

锛堜簲锛夌祼鍚堥噸瑜囩郸钘ユ瘨鎬ц│椹楅茶鐨勫畨鍏ㄨ棩鐞嗗绲傞粸鐨勬帰璁紱

锛堝叚锛夊畨鍏ㄨ棩鐞嗗绉戝鐮旂┒锛

1. 鏍稿績绲勫悎瑭﹂銆佽拷鍔犵殑瀹夊叏钘ョ悊瀛歌│椹椼佽鍏呯殑鐨勫畨鍏ㄨ棩鐞嗗瑭﹂锛

2. 鍠绲﹁棩鑸囧娆$郸钘ョ爺绌讹紱

3. 绲愬悎瀹夊叏钘ョ悊瀛搁茶鐨凱K/PD鐮旂┒锛

4. 褰卞儚瀛哥爺绌讹紱

5. 鐩搁棞妯″瀷鐮旂┒锛

6. 鍏跺畠鐮旂┒銆



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