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体外诊断临床试验中样本管理不足与建议
发布时间:2020-01-31

  摘要:赢发彩票代理我国体外诊断试剂的研发与产业化正飞速的发展,产品类型各异,进入临床试验的产品越来越多,为保证体外诊断试剂的安全及有效性,对于体外诊断试剂临床试验的规范性和数据质量的要求越来越严格。本文通过查阅文献、结合现行法规及具体实际,以体外诊断试剂临床试验用样本为重点,从试验准备阶段方案设计、试验阶段样本筛选使用、收尾阶段样本处理,浅谈体外诊断试剂临床试验样本管理存在的问题及应对措施,以期为完善我国体外诊断试剂临床试验样本的监督管理提供借鉴。

  关键词:赢发彩票代理体外诊断试剂; 临床试验; 样本管理; 问题分析;

  作者简介: *黄建英,E-mail:znyylcsy@126.com.;

  基金: 湖北省卫生和计划生育委员会联合基金临床研发项目(WJ2017H0015);湖北省卫生和计划生育委员会联合基金科技创新平台项目(WJ2018H0004);湖北省卫生和计划生育委员会联合基金临床研发项目(WJ2018H0011);

  TIWAIZHENDUAN(IVD)SHIJILINCHUANGSHIYANSHIZHIZAIXIANGYINGDELINCHUANGHUANJINGZHONG,DUIIVDSHIJIDELINCHUANGXINGNENGJINXINGDEXITONGXINGYANJIU。SUIZHEWOGUOSHENGWUJISHUDEXUNMENGFAZHAN,IVDCHANYECONGMENGYADAOGAOSUFAZHAN,YUELAIYUEDUODECHANPINJINRUSHICHANG。ZAIDIERLEI、DISANLEICHANPINHUODEZHUCEZHENGJINRUSHICHANGQIAN,WEIYANZHENGCHANPINDEANQUANXING、YOUXIAOXINGJIYU“JINBIAOZHUN”HUOMUQIANLINCHUANGGUANGFANPINGJIAPINZHIJIAOHAODEYISHANGSHICHANPINJIANDEDENGXIAOXING,ZAIYIBEIANDELINCHUANGSHIYANJIGOUKAIZHANLINCHUANGSHIYAN,SHIIVDCHANPINYANFADEBIJINGZHILU。

  IVDLINCHUANGSHIYANSHEJIDESHENGWUYANGBENLEIXINGBUYI,RURENTIXUEYE、NIAOYE、ZUZHIYE、XIONG(FU)QIANGJIYE、NAOJIYE、YANGSHUI、ZUZHIQIEPIAN、GUSUIDENG。JINNIANLAI,ZAIYIXILIESHENGWUYIYAOCHUANGXINZHONGYAOZHENGCETEBIESHI“JINGZHUNYILIAO”TICHUHOU,DAIBIAOZHEZHENDUANJISHUQIANDUANFANGXIANGDEJICHUFENZIZHENDUANSHIJIBIAOXIANCHUJIDAQIANLI[1],ZHIDAOYONGYAO、RENLEIJIYINJIANCEDECHANPINYUELAIYUEDUO[2],SHIDESHIYANYONGYANGBENDEHUOQU、CAIJI、ZHUANYUN、BAOCUN、SHIYONGKEXUEGUIFANHUAGUANLIDEZHONGYAOXINGRIYITUCHU。BENWENJIEHEXIANJIEDUANSHIJI,GUINAZONGJIEYIXIAIVDLINCHUANGSHIYANZHONGYANGBENGUANLICUNZAIDEZHUYAOWENTI,BINGPOUXIWENTICHANSHENGDEYUANYOU,ZHENDUIXINGJICHUGUANLIJIANYI,YIGONGGEFANGTANTAO。

  1、IVD临床试验样本管理存在的问题

赢发彩票代理   2016-2018NIAN3NIANJIAN,WEIGUANCHELUOSHI《GUOWUYUANGUANYUGAIGEYAOPINYILIAOQIXIESHENPINGSHENPIZHIDUDEYIJIAN》,GUOJIAYAOPINJIANDUGUANLIJU(NMPA),YUANGUOJIASHIPINYAOPINJIANDUGUANLIZONGJU(CFDA),2018NIAN8YUE29RICFDAZHENGSHIGENGMINGWEINMPA)GONGZUZHIKAIZHANLE6CIYILIAOQIXIEZHUCESHENQINGXIANGMULINCHUANGSHIYANJIANDUCHOUCHA,QIZHONGBAOKUO27JIALINCHUANGSHIYANJIGOUGONG13GEIVD.2018NIAN9YUE,NMPAFABULEDIYIPIJIANDUCHOUCHAQINGKUANGDEGONGGAO。BIZHEJIEHE2018NIANDUGONGGAOQINGKUANGJIXINGXIAOMIN[3]DEFENXI,GUINAFAXIAN:11ZHONGIVDZAI22JIALINCHUANGSHIYANJIGOUGONGJIANCHAFAXIAN40GEZHUYAOWENTI,YUYANGBENXIANGGUANWENTIDA22GE,ZHANBIWEI55%,QIZHONGTONGYIGESHIYANZHONGZHONGFUSHIYONGTONGYISHOUSHIZHEZAIBUTONGSHIJIANDUANCAIJIDEYANGBENWENTIYOU19GE、TICHUYANGBENWUSHUOMINGWENTIYOU2GE、YANGBENXINXIBUQUANWENTIYOU1GE。

  2016-2018NIAN,NMPAMEINIANKAIZHANLE2CIYILIAOQIXIEZHUCESHENQINGXIANGMULINCHUANGSHIYANJIANDUCHOUCHA,GONGJI20GEXIANGMU,TIWAIZHENDUANSHIJICHOUJIANLVJINWEI25%ZUOYOU。RANERMEINIANGUONEIJINRULINCHUANGSHIYANDEXIANGMUSHUYUANBUZHIZHEIXIE,WEIBEICHOUJIANDAODEXIANGMUYEYOUKENENGZAIYANGBENDESHEJI、CAIJI、XINXIBAOMI、CHUCUN、SHIYONG、GENZONG、XIAOHUIDENGGEFANGMIANGUANLISHANGCUNZAIWENTI,DUIQIZHONGZHUYAODEJIYOUZHENGYIDEWENTIJINXINGTAOLUNFENXI,YOUZHUYUTIWAIZHENDUANSHIJILINCHUANGSHIYANYANGBENGUANLIGUIFANXINGDETISHENG,CONGERSHILINCHUANGSHIYANSHIPINGGUCHUGAOZHILIANGDETIWAIZHENDUANSHIJI,FUWUYULINCHUANGHEHUANZHE。

IVD临床试验

配图 IVD临床试验

  2、问题分析及建议

  2.1 临床试验准备阶段

  2.1.1 SHIYANFANGANYANGBENSHEJI

  ZONGYANGBENLIANG、YANGXINGBINGLIJIHANJIANBINGLIDESHEJIJINJINIAN,NMPALUXUCHUTAILEBUFENIVDDEZHUCEJISHUSHENCHAZHIDAOYUANZE,RUTAIERRANSETIFEIZHENGBEITI(T21、T18、T13)JIANCESHIJIHE、RENBIAOPISHENGZHANGYINZISHOUTI(EGFR)TUBIANJIYINJIANCESHIJIDENG。DANHAIYOUDALIANGQITAZHONGLEICHANPINMEIYOUXIANGYINGBIAOZHUNHUOZHIDAOYUANZE。CHANPINYONGTUBUTONG,XIANGYINGDELINCHUANGSHIYANFANGFABIANYOUCHABIE,YOUYUDUIZONGYANGBENLIANG、YANGXINGBINGLIJIHANJIANBINGLIMEIYOUKEXUEYUGU,QIEGUODUONARUSHOUSHIZHEHUIZENGDAJINGFEI、RENLIJIWULIDENGYUANYIN,DADUOLINCHUANGSHIYANZHIZAI《TIWAIZHENDUANSHIJILINCHUANGSHIYANJISHUZHIDAOYUANZE》(YIXIAJIANCHENG《YUANZE》)ZUIDIYANGBENLIANGJICHUSHANGSHIDANGZENGJIA。YINCI,LINCHUANGSHIYANFANGANYANGBENRUXUANPAICHUBIAOZHUN、YANGBENLIANGDEKAOLIANGDENGQIANQISHEJIBUKEXUEHUOBUHELIZHIJIEYINGXIANGHOUXUSHIYANDEJINXING。

  YANGBENDEGENZONGDIAOCHA《YUANZE》DUIYUXINYANZHIIVDDELINCHUANGSHIYANGUIDING“DUIYONGYUZAOQIZHENDUAN、LIAOXIAOJIANCE、YUHOUPANDUANDENGYONGTUDEIVD,ZAIJINXINGYU”JINBIAOZHUN“DEBIJIAOYANJIUDETONGSHI,HAIBIXUDUISHOUSHIZHEJINXINGGENZONGYANJIU”.XUDUOYONGYURENLEIJIYINXINGWEIDIANJIANCEYONGTUDEIVDZAIBAOPISHI,GUOJIAYAOPINJIANDUGUANLIJUYILIAOQIXIEJISHUSHENPINGZHONGXIN(CMDE)SHENCHASHIYAOQIUGAILEICHANPINLINCHUANGSHIYANYEYINGDUISHOUSHIZHEJINXINGGENZONGDIAOCHA,YOUCICHANSHENGLEYIXILIEWENTI,RU:(1)GAILEICHANPINSHIYANSHIFOUXUYAOZUOYANGBENGENZONGDIAOCHA,GENZONGDIAOCHANAXIEYOUXIAOXINXI;(2)DUISHOUSHIZHEJINXINGGENZONGYANJIUSHIFOUDAIBIAOXUYUSHOUSHIZHEZHIJIEJIECHU,SHIFOUDENGTONGYUXUHUODESHOUSHIZHEZHIQINGTONGYI;(3)DANGSUOXUGENZONGDEXINXIDADUOKECONGYIYUANXITONGHUOQU,GAILEISHIJISHIFOURENGKEHUOMIANSHOUSHIZHEZHIQING;(4)RUBIXUHUODESHOUSHIZHEZHIQINGTONGYI,SHIDUISUOYOUHUANZHEZHIQINGHAISHIJINDUIGENZONGDESHOUSHIZHEZHIQING?

  YINCI,ZAILINCHUANGSHIYANKAIZHANQIAN,LINCHUANGSHIYANFANGANSHEJISHIZHONGZHONGZHIZHONG。DUISHENBANFANGERYAN,YISHIYINGDUIYANFADECHANPINZUOCHONGFENDEDIAOYAN,GENJULINCHUANGYUQIYONGTUQUEDINGLINCHUANGYONGYANGBENDELEIXING,XIANGGUANJIBINGDELINCHUANGFASHENGLV、TONGJIXUEYAOQIUDENGLAIKEXUEDISHEJIZONGYANGBENLIANG、YANGXINGBINGLIJIHANJIANBINGLI。RUYANGBENLIANGDEGUSUANFANGFA,KESHIDANGCANKAOCMDEXINFABUDE《TIWAIZHENDUANSHIJILINCHUANGSHIYANZHIDAOYUANZE(ZHENGQIUYIJIANGAO)》ZHONGYANGBENLIANGDEGUSUANGONGSHI;RUHANJIANBINGLIDEGUSUAN,JIANCERENLEIJIYINXINGDESHIJIMOUXIETUBIANJIYINXINGSHIFENHANJIAN,YINCIYINGJINKENENGZENGDAZONGYANGBENLIANGHUOSHIDANGNARUHUIGUXINGYANGBEN;ERSHIDUILINCHUANGJIGOUZUOCHONGZUDEDIAOYAN,YINGLEJIEJIGOUSHIFOUYOUCHONGZUDEFUHEFANGANYAOQIUDEYANGBEN;SANSHIYINGZUZHIGELINCHUANGSHIYANJIGOUYANJIUZHEZHAOKAIFANGANTAOLUNHUI,DUIFANGANYANGBENSHEJIDEKEXUEXINGJINXINGTAOLUN,ZUIZHONGQUEDINGTONGYIDESHIYANFANGAN;SISHIZAISHENQINGSHOUSHIZHEZHIQINGTONGYIHUOMIANSHI,ZUIHAONENGTIGONGGENZONGYANJIUBUHUIDUISHOUSHIZHECHANSHENGFENGXIANDEXIANGXISHUOMING,RUOLUNLIWEIYUANHUIRENWEIYINGHUODESHOUSHIZHEZHIQINGTONGYI,SHENBANFANGYINGANZHAOJIGOUZHIQINGTONGYILIUCHENG,JIJIPEIHEYANJIUZHEWANCHENGZHIQINGTONGYISHUDEQIANSHU。

  DUILUNLIWEIYUANHUIERYAN,TEBIESHIZUZHANGDANWEIDEWEIYUANZHUANJIA,YINGDUIFANGAN、HUOMIANZHIQINGDESHUOMINGJINXINGYANGESHENCHA,JUEDINGSHIFOUKEMIANYUZHIQING。RENWEICUNZAIWENTISHI,YINGTICHUXIANGYINGDEJIANYIYIGONGSHENBANFANGJIYANJIUZHECANKAOHOUXIUZHENG。LINGWAI,JIANYIDUIZHUANYEKESHISHIFOUJUBEIFUHEFANGANYAOQIUDEYANGBENJINXINGYUXIANSHENCHA,KEYISHUMIANXINGSHISHENCHAYANJIUZHETIJIAODE《KESHIYANGBENFUHELINCHUANGSHIYANXIANGMUYAOQIUDESHUOMING》ZILIAO。

  2.1.2 YANGBENXINXIWUYINSIBAOMICUOSHI

赢发彩票代理   YANGBENXINXIDEHUOQUCHUYANGBENBIAOQIANWAIHAIYOUYIYUANXINXIXITONG,XITONGBAOHANLEHUANZHEDENIANLING、XINGBIE、LINCHUANGZHENDUANSHENZHIGONGZUODANWEI、ZHUZHI、LIANXIDIANHUADENGZHONGYAOXINXI。《YUANZE》GUIDING“WEISHOUSHIZHEBAOMI,ZUNZHONGGERENYINSI”.ZHENGGELINCHUANGSHIYANCANYUZHEZHONGDUO,ZHEIXIEXINXINANBAOBUHUIBEIYOUYIHUOWUYIXIELU。IVDLINCHUANGSHIYANSHENGYUYANGBENYINFADELUNLIWENTIYIZHISHITAOLUNDEJIAODIAN[2,4].SUIRANGUONEIMUQIANSHANGWUYINSHOUSHIZHEXINXIXIELUERBEIQISUDEANLI,DANSHIMEIGUOHUANZHEMooreQISULIYONGQIYANGBENJINXINGYANJIUQIEWEIHUODEQIZHIQINGTONGYIDEGoldenYISHIDEANLIDAOSHIKEYIYINYIWEIJIAN[5].SUIRANFAGUANZUIZHONGPANDINGYISHENGBUSHUYU“QINQUAN”,DANSHIZHEIYEJIWOMENYIJINGSHI:WULUNLINCHUANGSHIYANSHIFOUHUODEZHIQINGHUOMIAN,DOUYINGZHIDINGYANGBENXINXIBAOHUCUOSHIBINGYOUXIAOZHIXING。

  DUILINCHUANGJIGOUERYAN,XITONGGUANLIZHEKEDUIYIYUANXINXIXITONGLISJIHISSHEZHI“FANGWENKONGZHI”[6],XITONGCAIYONGMIMABAOHU,LINCHUANGSHIYANYANGBENSHOUJIZHEHEXINXIFUHEZHEKEBEISHOUQUANWEIYIDEZHANGHUMIMA,MEICIFANGWENXITONGSHIYINGTIANXIE《FANGWENJILUBIAO》,JILUFANGWENZHEXINGMINGJIRIQI。SHENBANFANGJIJIANGUANBUMENRENYUANFANGWENXITONGSHI,YINGYOUYANJIUZHESHOUQUANJILUHUOZAIYANJIUZHEPEITONGXIAFANGWEN。

赢发彩票代理   DUISHENBANFANGJIYANJIUZHEERYAN,YANGBENBIXUQUBIAOSHI/NIMINGHUA,YINGGONGTONGZHIDINGBAOMICUOSHI,BINGTIXIANZAISHIYANFANGANHUOSHIYANHUANJIEBIAOZHUNCAOZUOGUICHENG(SOP)ZHONG,RUZAIYANGBENRUZUHOU、JINRUJIANCEQIAN,XIAOHUIHANYOUSHOUSHIZHEXINXIDEYUANSHITIAOMA[4],TIESHANGSUIJIBIANHAODELINCHUANGYONGYANGBENBIANHAOTIAOMA,SHIDEYANGBENSHOUJIZHE、FUHEZHE、JIANCEZHE、SHUJUTONGJIZHEGEZIDULI,YANGBENXINXIJINYANGBENSHOUJIZHEJIFUHEZHEZHIXIAO;ZAITIJIAOBAOPIZILIAOSHI,JIANYILINCHUANGBINGLIBAOGAOBIAONEIRONGJINBAOHANYANGBENBIANHAO(HUOYANGBENTIAOMAHAO,ZUOWEISHOUSHIZHEDEYUANWENJIANWEIYIDESUYUANBIANHAO)HESHIYANJIEGUO[7],KEYIYOUXIAODUJUEYINSIHEGERENXINXIDEXIEMI。

  2.2 临床试验进行阶段

  2.2.1 YANGBENZHONGFU

  《YILIAOQIXIELINCHUANGSHIYANXIANCHANGJIANCHAYAODIAN(2016NIAN)》BIAOMINGIVDLINCHUANGSHIYANYANGBENCHUYOUTESHUQINGKUANGWAIBUTUIJIANZHONGFUSHIYONG[8].DANSHIYANYANGBENZHONGFUSHIYONGQUEWEIZUOSHUOMINGDEQINGKUANG,KENENGSHIYIXIAYUANYINDAOZHI:YISHISHIYANKAIZHANQIANKESHIMEIYOUZHENGQUE、GUIFANDILIUQULINCHUANGYONGYANGBEN,ZENGDALELINCHUANGSHIYANJINXINGJIEDUANDESHIYANWUCHA[9];ERSHITONGYIGESHOUSHIZHEKENENGZAIBUTONGDESHIQIJUNCAIJIGUOYANGBEN,YANGBENLISHUYAOQIUGUODUO,YANGBENBUXIAOXINZHONGFURUZU;SANSHIWEIDUIRUZUDEYANGBENXINXIJINXINGFANFUHECHA,WEIFAXIANYANGBENZHONGFUQINGKUANG;SISHIYANGXINGYANGBENBUZU,ZHONGFUYANGBENCOUSHU。FAGUIDUIYANGXINGLVZHIYAOQIUFUHETONGJIXUEFENBU,CMDEYIBANYAOQIULINCHUANGYANGXINGLVBUSHAOYU30%[7],SHENBANFANGDUILINCHUANGSHIYANJIGOUKESHIYANGBENMEIYOUCHONGFENLEJIESHI,KENENGDAOZHISHIYANKAIZHANHOUCAIFAXIANYANGXINGYANGBENBUZU,WEILEGANSHIJIANJINDU,BIANYIZHONGFUYANGBENCOUSHUBUJIU。

  WEIBIMIANCHUXIANYISHANGWENTI,SHOUXIAN,LINCHUANGKESHIJIJIGOUBANYINGZHONGSHILINCHUANGBIAOBENCAIJIYAOQIU,ZHIDINGSHIYANSHIBIAOBENCAIJI、BAOCUNDENGSOP,DUIXIANGGUANRENYUANJINXINGZHUANTIPEIXUN,BIMIANLINCHUANGXIANGMUKAIZHANQIANGANRAOYINSUDECHUXIAN[10].QICI,SHENBANFANGANZHAOFANGANYANGBENRUXUAN/PAICHUBIAOZHUN,ZHIDINGYANGBENSHAIXUANRUZUSOP,SOPZHONGGUIDINGCHUCISHAIXUANYANGBENHOUBIXUZAIYIYUANLISHUOHISXINXIXITONGZHONGSUYUAN,YANGBENSHOUJIZHEJIFUHEZHESHUANGRENHECHA,ZHISHAO2CI,YANGBENXINXIWANZHENGQIEWUZHONGFUHOUCAIKEYIJINXINGXIAYIBUSHIYANCAOZUO,RUORENGYOUBUFUHEBIAOZHUNDEYANGBENRUZU,YINGJISHITICHUBINGZUOSHUOMING。ZAICI,SHENBANFANGZAISHIYANKAIZHANQIANYINGCHONGFENLEJIEZHUANYEKESHIXIANYOUYANGXINGYANGBENSHIFOUKEYIMANZULINCHUANGXUYAO,RUOBUNENG,YINGYANZHANGLINCHUANGSHIYANSHIJIAN,JIDAOYANJIUZHECHONGFENDESHIJIANSHOUJIYANGBENHUOXUNZHAOQITAMANZUYANGBENXUQIUDELINCHUANGJIGOU。ZUIHOU,JIGOUBANGONGSHIJISHENBANFANGLINCHUANGJIANCHAYUANCHULEDINGQIKAIZHANDELINCHUANGSHIYANSHOULI、ZHONGQI、JIETIZHIKONG/JIANCHAWAI,HAIKEYIBUDINGQIKAIZHANZHUANMENZHENDUIYANGBENSUYUANDEHECHA,BANGZHUYANJIUZHEGENGDUODEFAXIANYANGBENSHAIXUANCUNZAIDEWENTI。

  2.2.2 YANGBENGONGYONG

  IVDTONGLEIXINGCHANPINZAILINCHUANGSHIYANFANGFA、YUANLISHANGDAZHIXIANGTONG,YANFASHILIJIAOQIANGDESHENBANFANGJINGCHANGSHIJIGECHANPINYIQIJINRULINCHUANGSHIYAN,ZHEIYANGDADAJIESHENGLELINCHUANGSHIYANSHIJIAN。FAGUIMEIYOUMINGLINGJINZHIBUTONGXIANGMUYANGBENGONGYONG,BUTONGSHIYANJIGOUDUICIGUIDINGBUYI。IVDYANGBENDUOWEIKESHISHENGYUYANGBEN,“SHENGYUYANGBEN”JIEDINGSHISHOUSHIZHESUOJIESHOUDEJIANCHAHUOZHILIAO,CANYUSHIYANDEYANGBENTIJIYINGBUHUIDUOYUWEICANYUSHIYANDEYANGBEN,RUZAIMOULINCHUANGJIGOUKAIZHANDEKANGDANBAIMEI3(PR3)KANGTIJIANCESHIJIHEKANGSUIGUOYANGHUAWUMEI(MPO)KANGTIJIANCESHIJIDELINCHUANGSHIYAN[3],SHENBANFANGNARULE55LIXIANGTONGSHOUSHIZHEDEYANGBEN,YONGYUJINXINGLIANGGETIWAIZHENDUANSHIJILINCHUANGSHIYAN,GONGXUYAOQUANXUE2~3mL,SHENGYUTIJIGUODA,YINCIGONGYONGYANGBENHOUHUIRANGZHUANJIADUIRUZUYANGBENSHIFOUWEISHENGYUYANGBENDEZHENSHIXINGZHIYI。

  BIZHERENWEI,YANGBENSHIFOUNENGGONGYONG,YINGYIZHUANYEZUSHENGYUYANGBENZONGSHULIANGJITIJISHIFOUZUGOUWEIQIANTI,ZAIBUDUIHOUXUSHIYANCHANSHENGFENGXIANDEQIANTIXIAKEYIGONGYONG。DUISHENBANFANGERYAN,YINGKEXUEJISUANDANGEHUODUOGEXIANGMUSUOXUDEZONGYANGBENSHULIANGJITIJI,BINGCHONGFENLEJIEKESHIZONGYANGBENSHULIANGSHIFOUZUYIYONGYUDUOGEXIANGMU,RUOZUGOU,BUTONGXIANGMUYINGXUANZEBUTONGSHOUSHIZHEYANGBEN;RUOYANGBENSHULIANGBUZUERBUFENYANGBENSHENGYUTIJIJIAODA,YINGYUYANJIUZHEJILINCHUANGJIGOUFUZERENGOUTONG,HUODEQIGONGYONGYANGBENDETONGYI,GENJUKESHIYANGBENQINGKUANGHELISHEJIGONGYONGYANGBENSHULIANG。DUIYANJIUZHEERYAN,DANGTONGYIGONGYONGYANGBENHOU,YINGDUIMEIGERUZUDEYANGBENXINXIZUOHAOJILU,RUSHENGYUYANGBENTIJI,DANGSHENGYUYANGBENTIJIJIAODASHICAIKEBEIYONGYUBUTONGXIANGMU。DUILINCHUANGJIGOUERYAN,ZAIBUDINGQIDUIYANGBENSUYUANJIANCHASHI,KEZHONGDIANJIANCHANAXIEYANGBENSHIGONGYONGYANGBENJIBEIYONGYUNAXIEXIANGMU,JIANCHAGAIYANGBENDEYUANSHISHENGYULIANG,YIPANDUANGAISHENGYUYANGBENDEZHENSHIXING。

  2.2.3 YANGBENDECUNCHUWENDUJILUBUQUANHUOCHAOCHUGUIDINGFANWEI

  LINCHUANGFANGANZHONGHUIDUIYANGBENCHUCUNTIAOJIANZUOGUIDING,RU4℃~8℃LENGZANGBAOCUN,HUO(-25℃±5℃)LENGDONGBAOCUN,BUTONGYANGBENCHUCUNWENDUYAOQIUBUTONG。LINCHUANGYONGYANGBENCUNFANGDEBINGXIANGDUOCAIYONGJIEDIANJILUWENDUDEFANGSHI,RUMEIRIDEZAOSHANG9DIANJIXIAWU4DIANZHINENGZIDONGCAIJIYICI,YOUXIEZHIYOUKESHIRENYUANSHOUDONGJILU,WUFAXINGCHENGWANZHENGLIANGUANDEWENDUQUXIANJILU。YINCIYANGBENZAIJIEDIANYIWAIDESHIJIANKENENGCUNZAICHAOCHUGUIDINGWENDUFANWEIDEFENGXIAN。

赢发彩票代理   KESHIKEXUANYONGZHINENGHUACHENGDUJIAOGAODEBINGXIANGZUOWEILINCHUANGYANGBENCHUCUNZHUANYONGBINGXIANG,HUOSHIZAIPUTONGBINGXIANGFANGZHIWENDUJILUYI,SUISHIJILUYANGBENCHUCUNQIJIANWENDUBIANHUA。YANJIUZHEZAISHAIXUANYANGBENHOUFANGRULINCHUANGZHUANYONGBINGXIANGCHUCUN,JILUBINGXIANGBIANHAO、YANGBENRUKUSHULIANGJISHIJIAN。BUDINGQIGUANCHABINGXIANGWENDU,DANGFAXIANCUNZAICHAOWENXIANXIANGSHI,YINGJISHIDIAOZHENG,ZUOHAOJILU。

赢发彩票代理   2.2.4 YANGBENSHIYONGJILUBUYIZHI

  YANGBENSHIYONGJILUBUYIZHIQINGKUANGDUOBIAOXIANZAIYANGBENCHURUKUSHULIANGBUYIZHI、YANGBENCHURUKUYUSHIJIDECHURUKUJILUWUFAYIYIDUIYING。YANJIUZHEJIANGSHAIXUANDEFUHEFANGANGUIDINGDEYANGBENFANGRUBINGXIANGDEGUOCHENGWEIYANGBENRUKU,YANJIUZHECONGBINGXIANGNACHUYANGBENBINGSHIYONGDEGUOCHENGWEICHUKU。YANGBENSHIYONGYUSHIJIJIANCEDE,YINCIYANGBENDECHUKUYINGYUSHIJIDECHUKUYIYIDUIYING。RUOSHIMEICIFANGRU、NACHUDEGUOCHENGMEIYOUZUOHAOXIANGYINGDEYUANSHIJILU,HUOSHIJILUCUOWU,JIUHUIDAOZHIYANGBENSHIYONGJILUBUYIZHI。

  SHOUXIAN,SHENBANFANGYINGYUYANJIUZHEGENJUXIANGMUTEDIAN,ZHIDINGGUIFANDESHIYANGUOCHENGGELEIBIAOGE,RU《LINCHUANGYANJIUYANGBENCHURUKUTAIZHANG》、《SHIJICHUCUNJICHURUKUJILUBIAO》,BIAOGEZHONGYINGHANYOUYANGBENBAOCUNWEIZHI、BAOCUNWENDU、BINGXIANGBIANHAO、RIQI、YANGBENLEIXING、YANGBEN/SHIJIRUKUSHULIANG、YANGBEN/SHIJICHUKUSHULIANG、YONGTU、SHIYONGREN、GUANLIYUANDENGXINXI。QICI,ZHUYAOYANJIUZHEYINGZHIDINGXIANGXIDEZHIZEFENGONG,ZHIDINGZHUANRENFUZEYANGBEN/SHIJIDEBAOCUN、FENFAGUANLI,QITAYANJIUZHESHIYONGYANGBENHESHIJIJINXINGSHIYANSHIBIXUQUDEGUANLIYUANTONGYI,CHURUKUBIAOGEYOUGUANLIYUANTONGYIGUANLI,DUCUSHIYONGRENRUSHITIANXIEJILUBIAOGE。

  2.3 临床试验收尾阶段

  LINCHUANGSHIYANJIESHUHOU,YINGDUILINCHUANGYONGYANGBENJINXINGHUISHOUHUOXIAOHUI。HUISHOU/XIAOHUIDESHIJIAN、FANGSHICUOWU,CAOZUOSHIWURENJIANDUDEQINGKUANGDOUYOUKENENGFASHENG。

  LINCHUANGYONGYANGBENHUISHOUHUOXIAOHUISHIJIANYINGZAIQUERENLINCHUANGYANGBENDEJIANCE、FUCEWANCHENGHOU。《YUANZE》ZHONGWEIDUISHIYANWANCHENGHOUYANGBENDEHUISHOUZUOXIANGGUANGUIDING,《TIWAIZHENDUANSHIJILINCHUANGSHIYANZHIDAOYUANZE(ZHENGQIUYIJIANGAO)》GUIDING“ZAIFUHEYANGBENBAOCUNTIAOJIANXIA,YANGBENYINGZHISHAOLIUCUNZHICHANPINSHANGSHI”,GAIGUIDINGTIXIANLEWEILAIJIANGUANQUSHI,SUIWEIZHENGSHIFABU,DANYEKESHIDANGCANKAO。YANGBENXIAOHUISHIYINGANZHAOKESHISOPGUIDINGDIURUYILIAOFEIQIWUZHUANYONGHUANGSELAJITONG,BINGQIEYINGZAIQITAYANJIUZHEJIANDUDEQINGKUANGXIACAOZUO。CAOZUOWANHOUTIANXIE《LINCHUANGSHIYANWUPINHUISHOUYUXIAOHUIQINGDAN》,CAOZUORENJIJIANDURENJUNXUQIANMINGQUEREN。

  3、结论

  BENWENZONGJIEGUINALEWOGUOIVDLINCHUANGSHIYANZHONGYANGBENZAIFANGANSHEJI、HUOQU、SHAIXUAN、XINXIBAOMI、CHUCUN、SHIYONG、GENZONGJIXIAOHUIDENGHUANJIERONGYIFASHENGDEHUOZHEYOUYIHUODEWENTI,BINGPOUXIWENTICHANSHENGDEYUANYOU,ZHENDUIXINGJICHULEXIANGGUANJIANYI。IVDLINCHUANGSHIYANZHILIANGKONGZHIDEXIAOGUOYUCHANPINBAOPIDEMINGYUNXIXIXIANGGUAN,GENGZHIJIEYINGXIANGCHANPINFUWUDEYUANTOU---HUANZHEDEJIANKANGHELIYI,ERTIWAIZHENDUANSHIJIYANGBENGUANCHUANLINCHUANGSHIYANDESHIZHONG,YANGBENZHENSHIYUGUIFAN,YINGXIANGCHANPINLINCHUANGSHIYANDEHEGUIXINGHEYOUXIAOXING。RUHEGUIFANXINGGUANLILINCHUANGSHIYANYONGYANGBEN,SHENBANFANG、YANJIUZHE、JIGOURENYUANJIQITALINCHUANGSHIYANCANYUZHEJUNYOUZEREN。ZHIYOUJIAQIANGTIWAIZHENDUANSHIJILINCHUANGSHIYANYANGBENJIQITAFANGMIANDEJIANDUGUANLISHUIPING,JIJITUIDONGIVDLINCHUANGSHIYANGENGJINGXIHUAZHIDAOYUANZEDECHUTAI、WANSHANFAGUITIXIDEJIANSHE,CAINENGBAOZHANGLINCHUANGSHIYANDEKEXUEXING、GUIFANXINGHEZHENSHIYOUXIAOXING,CONGERZHENZHENGBAOZHANGRENMINQUNZHONGDEJIANKANGHELIYI。

  CANKAOWENXIAN

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