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09 2020-12

打针用紫杉醇(白卵白连系型)仿造药研讨技术 指点准绳(试行)

YI、GAISHUDAZHENYONGZISHANCHUN(BAILUANBAILIANXIXING)YINCIRENXUEBAILUANBAIWEIFULIAOZHIBEIDEWEILIZHIJI。YUZISHANCHUNDAZHENYEBINI,BIMIANLEJUYANGYIXIBIMAYOUDELIYONG,XIAJIANGLEGUOMINXING,JINBULELINCHUANGLIYONGJINCHENGZHONGHUANZHENAISHOUXINGHESHIYINGXING。BENZHIDIANZHUNSHENGLIANXIDAZHENYONGZISHANCHUN(BAILUANBAILIANXIXING)DEZHIJITEDIAN,TICHUFANGZAOYAOKAIPI...

08 2020-12

盐酸多柔比星脂质体打针液仿造药研讨技术指点准绳(试行)

YI、GAISHUYANSUANDUOROUBIXINGZHIZHITIDAZHENYESHIJIANGYANSUANDUOROUBIXINGBAOGUOYUZHIZHITINEIGOUCHENGDETEBIEDAZHENJI。BENZHIDIANZHUNSHENGANZHAOJIENALIUSUANANTIDUFAZHIBEIDEYANSUANDUOROUBIXINGZHIZHITIDAZHENYEDEZHIJITEDIAN,TICHUFANGZAOYAOKAIPIJINCHENGZHONGYAOXUEYANTAO、FEILINCHUANGYANTAOHESHENGWUDENGXIAOXINGYANTAODEJISHUQINGQIU,ZHIZAIWEIGAIFANGZAOYAODEYANFATI...

08 2020-12

化学药品打针剂出产所用的塑料组件体系相容性研讨技术指南(试行)

HUAXUEYAOPINDAZHENJICHUCHANJINCHENGLIYONGDESULIAOZUJIANTIXI,NENGGOUYUYETIDAZHANGBINGFASHENGBICIGANHUA,ZHISHIXIANGGANJINCHUWUDEFASHENGHEDUIJI。JINCHUWUZAIYETIZHONGYANXUCUNZAIBINGZHONGJIUTONGBAOZHIZHONGCHANWUZHONG,NENGGOUYINGXIANGCHANWUPINZHIHE/HUOHUANZHENINGJING。WEIKEXUETIAOXUANHUAXUEYAOPINDAZHENJICHUCHANJINCHENGZHONGLIYONGDESULIAOZUJIANTIXI,QUEBAOSULIAOZUJIAN...

08 2020-12

附件 1 化学药品打针剂包装体系密封性研讨技术指南 (试行)

YI、GAISHUBAOZHUANGTIXISHIZHIBAORONGHEYANHUYAOPINDEYIQIEBAOZHUANGZUJIANDEZONGHE,BAOHANJIANJIEDAZHANGYAOPINDEBAOZHUANGZUJIANHECIJIBAOZHUANGZUJIAN。BENJISHUZHINANSHOUYAOHEYONGYUHUAXUEYAOPINDAZHENJIBAOZHUANGTIXI。DAZHENJIDEBAOZHUANGTIXIYINGNENGJIANCHICHANWUNEIRONGWUWANQUAN,TONGSHIBIMIANWEISHENGWUQINRU。BAOZHUANGTIXIMIFENGXING(package inte...

08 2020-12

注册分类 4、5.2 类化学仿造药(口服固体系体例剂)生物等效性研讨批次样品批...

WEIGUANCHEZHONGGONGZHONGXINBANGONGTING、GUOWUYUANBANGONGTING《DUIYUSHENRUSHENPINGSHENPIGUIZHIDINGXINGUDONGMIANLIYAOPINYILIAODONGXILIYIDEDINGJIAN》(TINGZI〔2017〕42 HAO)、GUOWUYUANBANGONGTING《DUIYUDINGXINWANMEIFANGZAOYAOGONGJIBAOZHENGJILIYONGZHENGCEDEDINGJIAN》(GUOBANFA〔2018〕20 HAO)JINGLI,WANMEIKOUFUGUTIFANGZAOYAOZHUCEQINGQIUDEJI...

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