秒速赛车控制器

當前位置: 首頁 > 政策法規 > 化學藥
化學藥
化學藥品注射劑仿制藥質量和療效一致性評價技術要求發布
發布時間: 2019-11-07     來源:

TESHUZHUSHEJIHUAXUEFANGZHIYAOYUANZESHANGYINGFUHE《HUAXUEYAOPINZHUSHEJIFANGZHIYAOZHILIANGHELIAOXIAOYIZHIXINGPINGJIAJISHUYAOQIU》DEYAOQIU,BENWENJIANXIZAICIJICHUSHANGDEBUCHONG,ZHIZAITICHUTESHUZHUSHEJIFANGZHIYAOYANFADEZHENGTISILUHEYIBANYUANZE,WEITESHUZHUSHEJIFANGZHIYAODEYANFATIGONGJISHUZHIDAO。

 

秒速赛车控制器11YUE5RI,CDEFABUTESHUZHUSHEJIZHILIANGHELIAOXIAOYIZHIXINGPINGJIAJISHUYAOQIU(ZHENGQIUYIJIANGAO)。

 

FU:

HUAXUEYAOPINZHUSHEJIFANGZHIYAO(TESHUZHUSHEJI)ZHILIANGHELIAOXIAOYIZHIXINGPINGJIAJISHUYAOQIU(ZHENGQIUYIJIANGAO)

秒速赛车控制器TESHUZHUSHEJISHIZHIYUPUTONGZHUSHEJIXIANGBI,TESHUZHUSHEJIDEZHILIANGJIQIHUOXINGCHENGFENDETINEIXINGWEISHOUCHUFANGHEGONGYIDEYINGXIANGJIAODA,KENENGJINYIBUYINGXIANGZHIJIZAITINEIDEANQUANXINGHEYOUXIAOXING,LIRUZHIZHITI、JINGMORU、WEIQIU、HUNXUANXINGZHUSHEJIDENG。

秒速赛车控制器TESHUZHUSHEJIHUAXUEFANGZHIYAOYUANZESHANGYINGFUHE《HUAXUEYAOPINZHUSHEJIFANGZHIYAOZHILIANGHELIAOXIAOYIZHIXINGPINGJIAJISHUYAOQIU》DEYAOQIU,BENWENJIANXIZAICIJICHUSHANGDEBUCHONG,ZHIZAITICHUTESHUZHUSHEJIFANGZHIYAOYANFADEZHENGTISILUHEYIBANYUANZE,WEITESHUZHUSHEJIFANGZHIYAODEYANFATIGONGJISHUZHIDAO。

一、總體考慮

秒速赛车控制器DUIYUTESHUZHUSHEJI,YOUYUZHIJITEXINGDEFUZAXING,YINGJIYUZHIJITEXINGHECHANPINTEZHENG,CAIQUZHUBUDIJINDEDUIBIYANJIUCELVE,SHOUXIANKAIZHANSHOUSHIZHIJIYUCANBIZHIJIYAOXUEJIFEILINCHUANGDEBIJIAOYANJIU,RANHOUJINXINGRENTISHENGWUDENGXIAOXINGYANJIU,BIYAOSHIKAIZHANJINYIBUDELINCHUANGYANJIU。RUOYAOXUEYANJIUHE/HUOFEILINCHUANGYANJIUJIEGUOTISHISHOUSHIZHIJIYUCANBIZHIJIBUYIZHI,SHENQINGRENYINGDUISHOUSHIZHIJICHUFANGGONGYIJINYIBUYOUHUAHOUZHONGXINKAIZHANYANJIU。

二、藥學研究

GENJU《HUAXUEYAOPINZHUSHEJIFANGZHIYAOZHILIANGHELIAOXIAOYIZHIXINGPINGJIAJISHUYAOQIU》,TESHUZHUSHEJIYIZHIXINGPINGJIAZAIANZHAOSHANGSHUJISHUYAOQIUKAIZHANYANJIUDETONGSHI,HUANXUGENJUTESHUZHUSHEJIDETEDIAN,CANZHAOFDA、EMAFABUDETESHUZHIJIXIANGGUANJISHUYAOQIU,KEXUESHEJISHIYAN。JIANYIGUANZHUYIXIAWENTI:

(YI)CHUFANGGONGYI

CHUFANGYUANZESHANGYINGYUCANBIZHIJIYIZHI,JIANYIDUIFULIAODEXINGHAOJIKENENGYINGXIANGZHUSHEJITINEIXINGWEIDEFULIAODECQAJINXINGYANJIU。

秒速赛车控制器TESHUZHUSHEJIDESHENGCHANGONGYIKENENGYINGXIANGYAOWUTINEIXINGWEI,XUSHENRUYANJIU;DUIYUCAIYONGWUJUNGONGYISHENGCHANDETESHUZHUSHEJI,XUTEBIEZHUYIGESHENGCHANBUZOUDEWUJUNBAOZHENGCUOSHIHEYANZHENG。

秒速赛车控制器ZHUCEPIHESHANGYEPIDESHENGCHANGONGYIJIPILIANGYUANZESHANGYINGBAOCHIYIZHI。ZHUCEPIYANGPINPILIANGCANZHAOFABUDE《HUAXUEFANGZHIYAOZHUCEPISHENGCHANGUIMODEYIBANXINGYAOQIU(SHIXING)》ZHIXING。

(ER)ZHILIANGYANJIU

KAOCHADEGUANJIANZHILIANGSHUXINGKENENGBAOKUODANBUXIANYUYIXIANEIRONG:LIHUAXINGZHI(RUXINGZHUANG,NIANDU,SHENTOUYAMOERNONGDU,pHZHI/SUANJIANDUDENG),ZetaDIANWEI,LIZIXINGTAI,LIJINGJIFENBU(RUD10,D50,D90DENG),TIWAIRONGCHU/SHIFANGXINGWEI,YOULIHEJIEHEYAOWU,YAOWUJINGXINGHEJIEJINGXINGTAI。

YUANZESHANGYINGTIGONGZHISHAO3PICICANBIZHIJIYANGPINDEZHILIANGDUIBIKAOCHASHUJU。

(SAN)RENTISHENGWUDENGXIAOXINGYANJIU/LINCHUANGSHIYANDEKAOLV

YINGCAIYONGSHANGYEPILIANGDEYANGPINJINXINGRENTISHENGWUDENGXIAOXINGYANJIUHE/HUOLINCHUANGSHIYAN。

秒速赛车控制器DUIYUFDAHUOEMAYIGONGBUZHIDAOYUANZEDETEDINGZHUSHEJIPINZHONG,JIANYICANZHAOQIJISHUYAOQIUKAIZHANYUCANBIZHIJIDEDUIBIYANJIU。

三、非臨床研究

YUPUTONGZHUSHEJIBUTONG,TESHUZHUSHEJIJINRUTINEIHOUTONGCHANGCUNZAISHIYAOGUOCHENGHETIYECHENGFENXIFUDENGYINSU,YINCI,SHOUSHIZHIJIYUCANBIZHIJICHUFANGHEGONGYIDECHAYIKENENGDAOZHIYAOWUTINEIYAODAIDONGLIXUEXINGWEIFASHENGGAIBIAN,CONGERDAILAIYOUXIAOXINGHEDUXINGDEBIANHUA,ERJINPINGYAOXUETIWAIDUIBIYANJIUWANGWANGBUZUYICHONGFENFANYINGSHOUSHIZHIJIYUCANBIZHIJITINEIXINGWEIDECHAYI。JIYUSHANGSHUKAOLV,ZAIKAIZHANRENTISHENGWUDENGXIAOXINGYANJIUHUOLINCHUANGSHIYANQIAN,YINGXUANZEHESHIDEDONGWUZHONGSHUJINXINGFEILINCHUANGYAODAIDONGLIXUEDUIBIYANJIU,YICHONGFENTISHISHOUSHIZHIJIYUCANBIZHIJIZAITINEIYAODAIDONGLIXUEXINGWEIHE/HUOZAIYAOXIAO/DUXINGBAQIGUANFENBUDEYIZHIXING。

秒速赛车控制器JIANYUTONGCHANGZHIYOUCONGZHIJIZHONGSHIFANGCHULAIDEYAOWUCAINENGZAITINEIFAHUIHUOXING,JIANYIZAICEDINGXUEYAONONGDUSHIFENBIECEDINGFUZAIYAOWUHESHIFANGYAOWUDENONGDU。

四、臨床研究

ZAIYANJIUPINGGUSHOUSHIZHIJIYUCANBIZHIJIZAIYAOXUEJIFEILINCHUANGSHANGJUYOUYIZHIXINGDEJICHUSHANG,FANGKEKAIZHANLINCHUANGYANJIU。LINCHUANGYANJIUTONGCHANGYINGCAIYONGZHUBUDIJINYANJIUCELVE,YINGSHOUXIANJINXINGRENTISHENGWUDENGXIAOXINGYANJIU,BIYAOSHIKAIZHANJINYIBUDELINCHUANGYANJIU。

秒速赛车控制器(YI)RENTISHENGWUDENGXIAOXINGYANJIU

秒速赛车控制器JIANLIJUYOUQUFENLIDERENTISHENGWUDENGXIAOXINGYANJIUFANGFA。YIBANYAOQIUHESHIYANSHEJIKECANZHAO《YIYAODONGXUECANSHUWEIZHONGDIANPINGJIAZHIBIAODEHUAXUEFANGZHIYAORENTISHENGWUDENGXIAOXINGYANJIUJISHUZHIDAOYUANZE》HE《SHENGWUDENGXIAOXINGYANJIUDETONGJIXUEZHIDAOYUANZE》DENGXIANGGUANZHIDAOYUANZE。JUTIYANJIUJIANYIGUANZHUYIXIAJIGEFANGMIAN:

YANJIUSHEJI:TONGCHANGCAIYONGSUIJI、DANCIGEIYAO、JIAOCHAYANJIUSHEJI。TESHUQINGKUANGXIA,YINGJIYUYAOWUTEDIAN、SHIYINGZHENGRENQUNDENGXUANZEHELIDEYANJIUSHEJI。

SHOUSHIZHE:TONGCHANGCAIYONGJIANKANGSHOUSHIZHE。DANGRUXUANJIANKANGSHOUSHIZHECANYUSHIYANKENENGMIANLINANQUANXINGFANGMIANDEFENGXIANSHI,JIANYIXUANZESHIYANYAOWUDENIDINGSHIYINGZHENGHUANZHE。

秒速赛车控制器YANGBENLIANG:RUXUANSHOUSHIZHEDELISHUYINGSHISHENGWUDENGXIAOXINGPINGJIAJUYOUZUGOUDETONGJIXUEXIAOLI。

JIANCEWUZHI:TESHUZHUSHEJIHUOXINGWUZHIZAITINEIRUTONGSHICUNZAIDUOZHONGXINGTAI,SHENGWUDENGXIAOXINGYANJIUYINGCHONGFENKAOLVGEZHONGXINGTAIYAOWUDUIANQUANXINGHEYOUXIAOXINGDEYINGXIANG,JIEHEYAOWUTEDIANXUANZEKEXUE、HELIDEJIANCEWUZHI。JIANCEFANGFAXUJINGGUOCHONGFENYANZHENG,BINGDUIMUBIAOJIANCEWUZHIJUYOUZUGOUQUFENLI,DUISHOUSHIZHIJIHECANBIZHIJIDECHAYIJUYOUZUGOULINGMINDU。

SHENGWUDENGXIAOXINGPINGJIAZHIBIAO:YINGTIGONGBAOKUOSHOUSHIZHIJIHECANBIZHIJIDEAUC0-t、AUC0-∞、CmaxJIHEJUNZHI、JIHEJUNZHIBIZHIJIQI90%ZHIXINQUJIANDENG。TESHUQINGKUANGXIA(RU:WEIQIUDENG),KENENGXUYAOZENGJIABUFENBAOLULIANGZHIBIAOLAIGUANCEZAOQIBAOLULIANGHUOTEDINGSHIDUANDEBAOLULIANG。

SHENGWUDENGXIAODEJIESHOUBIAOZHUN:YIBANQINGKUANGXIA,DUIYUZHUYAOZHONGDIANZHIBIAO,SHANGSHUCANSHUJIHEJUNZHIBIZHIDE90%ZHIXINQUJIANSHUZHIYINGBUDIYU80.00%,QIEBUCHAOGUO125.00%。

YUSHIYAN:ZHENGSHISHIYANZHIQIAN,KEZAISHAOSHUSHOUSHIZHEZHONGJINXINGYUSHIYAN,YONGYIYANZHENGFENXIFANGFA(BAOKUODUIJIANCEWUZHIDEQUFENLI)、PINGGUBIANYICHENGDU、YOUHUACAIYANGSHIJIAN,YIJIHUODEQITAXIANGGUANXINXI。YUSHIYANDESHUJUBUNENGNARUZUIZHONGTONGJIFENXI。

QITA:

秒速赛车控制器ZHUCESHENBAOSHI,CHULEYINGMANZUXIANXINGDEXIANGGUANSHENBAOZILIAOYAOQIUZHIWAI,HUANYINGJIYUCHANPINTEDIAN,DUIXIANGGUANGUANJIANWENTIDEKEXUEHELIXINGJINXINGCHONGFENLUNZHENG,BAOKUODANBUXIANYUSHIYANSHEJI、SHOUSHIZHEXUANZE、YANGBENLIANG、JIANCEWUZHI、SHENGWUDENGXIAOXINGPINGJIAZHIBIAODENG。

秒速赛车控制器YIYAOXIAOXUEZHIBIAOWEIZHONGDIANPINGJIAZHIBIAODERENTISHENGWUDENGXIAOXINGYANJIUCANZHAOXIANGGUANZHIDAOYUANZEZHIXING。

TESHUQINGKUANGSHI,KESHIXIANYUJIANGUANJIGOUGOUTONG。

秒速赛车控制器(ER)SUIJIDUIZHAOLINCHUANGSHIYAN

SHIFOUXUYAOJINXINGSUIJIDUIZHAOLINCHUANGSHIYAN,YINGJIYUYAOWUTEDIAN,YIJIQIANQIYAOXUE、FEILINCHUANG、RENTISHENGWUDENGXIAOXINGYANJIUJIEGUODENGTAOLUNQUEDING。DUIYURENTISHENGWUDENGXIAOXINGYANJIUJIEGUOXIANSHISHOUSHIZHIJIYUCANBIZHIJIBUDENGXIAODE,SHENQINGRENYINGDUISHOUSHIZHIJICHUFANGGONGYIJINYIBUYOUHUA,ZHONGXINKAIZHANDUIBIYANJIU。

秒速赛车控制器DUIYUYIXIAQINGKUANG(BUXIANYU),JIANYIKAIZHANSUIJIDUIZHAOLINCHUANGSHIYANYANJIU,ZHENGMINGSHOUSHIZHIJIYUCANBIZHIJIDEDENGXIAOXING:

(1)QUEFAZHUNQUEKEKAODESHENGWUYANGBENCEDINGFANGFA,WUFATONGGUOSHENGWUDENGXIAOXINGYANJIUPINGJIASHOUSHIZHIJIYUCANBIZHIJISHIFOUJUYOUSHENGWUDENGXIAOXING。

(2)RENTISHENGWUDENGXIAOXINGYANJIUJIEGUOXIANSHISHOUSHIZHIJIYUCANBIZHIJICUNZAICHAYI,QIESHANGBUQUEDINGGAICHAYISHIFOUHUIDUIYAOWUDEANQUANYOUXIAOXINGCHANSHENGMINGXIANYINGXIANG。

秒速赛车控制器(3)TIXUNHUANZHONGDEYAOWUNONGDUYULIAOXIAOHUOANQUANXINGXIANGGUANXINGJIAOCHA,RENTISHENGWUDENGXIAOXINGYANJIUBUZUYIPINGJIASHOUSHIZHIJIYUCANBIZHIJIDELIAOXIAO、ANQUANXINGYIZHI。

秒速赛车控制器DUIYUKAIZHANLINCHUANGSHIYANDEQINGKUANG,JIANYISHIXIANYUJIANGUANJIGOUGOUTONG。