浅谈美国FDA不劣性试验指引最终版之修订-财团法人医药品查验中心.PDF

娣鸿珖 缇庡湅FDA 涓嶅姡鎬ц│椹楁寚寮曟渶绲傜増涔嬩慨瑷 鍚抽泤鐞 1 鍓嶈█ 缇庡湅椋熷搧鍜岃棩鐗╃鐞嗗眬(US FDA)鏂?010 骞村畬鎴 銆屼互涓嶅姡鎬ц│椹楃⒑绔嬭棩鍝佹湁鏁堟€ф寚 寮曡崏妗 (Draft Guidance for Industry 锛歂on-inferiority Clinical Trials) 銆嶏紝涔嬪緦姝风稉鍏勾鑱藉彇 [1] 鍚勬柟鎰忚 涓︿簣淇▊锛屾柤2016 骞?1鏈堥爳甯冩渶绲傜増鏈 銆傛湰鎸囧紩鍚屾檪鍙栦唬 2010 骞存墍鐧 甯冧箣 [2] 銆屼娇鐢ㄤ笉鍔ｆ€ц│椹楁敮鎸佹姉鑿岃棩鍝佷笂甯傝ū鍙寚寮曘€ 銆 鏈寚寮曟墍 鎺㈣◣鐨 涓嶅姡鎬?non-inferiority, NI瑭﹂) 锛屼富瑕侀嚌灏嶅嵄鍙婄敓鍛芥垨鍏蜂笉鍙€嗗偡瀹 鐨勭柧鐥 锛岀暥 甯傞潰涓婂凡鏈夌稉鏍稿噯銆佹晥鐩婅壇濂界殑钘ュ搧鍙緵浣跨敤 锛屼笖涓嶆不鐧 銆佹垨浠 瀹夋叞鍔戞垨 闈 甯