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  • 2023-03-06

    Thisannexprovidesinformationforaninvivostratumcorneumsampling(ortapestripping(TS))studyforsemi-solidformulationsasapermeationkineticmethodtoshowequivalence,inlieuofatherapeuticequivalencestudy.本附錄提供了半固體(ti)制劑的體(ti)內(nei)角質層取樣(或膠(jiao)帶剝離(TS))研究的信息,作為滲透動(dong)力學方法,以...

  • 2023-03-03

    復方制劑(ji)(ji)是(shi)由多個成(cheng)(cheng)分(fen)(fen)或多個組(zu)(zu)分(fen)(fen)所(suo)組(zu)(zu)成(cheng)(cheng)的(de)(de)(de)單一制劑(ji)(ji),各(ge)成(cheng)(cheng)分(fen)(fen)或組(zu)(zu)分(fen)(fen)具有一定的(de)(de)(de)配(pei)伍和(he)配(pei)比關(guan)系。復方制劑(ji)(ji)正逐漸成(cheng)(cheng)為化(hua)藥(yao)企業進行(xing)戰略布局(ju)時選(xuan)擇(ze)的(de)(de)(de)重要細(xi)分(fen)(fen)賽道。復方制劑(ji)(ji)開發(fa)過(guo)程中會面臨藥(yao)物組(zu)(zu)分(fen)(fen)選(xuan)擇(ze)、穩定性、釋(shi)放速率(lv)等制劑(ji)(ji)工藝技術壁壘,各(ge)組(zu)(zu)分(fen)(fen)溶(rong)出釋(shi)放行(xing)為的(de)(de)(de)差異會極大影響(xiang)(xiang)藥(yao)物療(liao)效。我國藥(yao)品監管部門也已(yi)經關(guan)注到(dao)原(yuan)(yuan)料藥(yao)的(de)(de)(de)不同(tong)晶型可(ke)能對藥(yao)物的(de)(de)(de)安(an)全性、有效性和(he)質(zhi)量可(ke)控(kong)性造成(cheng)(cheng)影響(xiang)(xiang),并提(ti)出《化(hua)學(xue)仿制藥(yao)晶型研究技術指導原(yuan)(yuan)則》。在復方制劑(ji)(ji)開發(fa)過(guo)程中,測定不同(tong)原(yuan)(yuan)料藥(yao)組(zu)(zu)分(fen)(fen)的(de)(de)(de)表觀溶(rong)出度,研究晶型、粉(fen)碎處理(li)工藝、混合...

  • 2023-02-21

    溶出儀應該怎樣(yang)使用(yong)(yong)(yong)?你(ni)知道是怎樣(yang)的流程(cheng)嗎?一、試(shi)驗(yan)準備:1、用(yong)(yong)(yong)戶(hu)按(an)介紹,進(jin)行(xing)(xing)了必(bi)要(yao)的用(yong)(yong)(yong)戶(hu)設置(zhi)、儀器(qi)設置(zhi)、程(cheng)序編(bian)輯后,即可進(jin)行(xing)(xing)溶出試(shi)驗(yan)。2、升(sheng)起(qi)機頭(tou),向水(shui)浴(yu)箱(xiang)中注(zhu)水(shui)至刻(ke)度(du)線,向各(ge)溶出杯中注(zhu)入經(jing)脫氣處理的溶媒,再將(jiang)機頭(tou)下降至底(di)位。3、在(zai)5自(zi)動運行(xing)(xing)界面選擇(ze)預先編(bian)輯好的程(cheng)序,開始試(shi)驗(yan)。4、儀器(qi)自(zi)動進(jin)行(xing)(xing)水(shui)浴(yu)的循(xun)環(huan)加(jia)熱,待(dai)溶媒溫度(du)穩定(ding)(ding)到設定(ding)(ding)值時,按(an)用(yong)(yong)(yong)戶(hu)6預約加(jia)熱的設定(ding)(ding),開始試(shi)驗(yan)。二、槳法自(zi)動運行(xing)(xing):1、用(yong)(yong)(yong)戶(hu)根(gen)據實際需要(yao),進(jin)行(xing)(xing)同步投藥或序列投藥第(di)一個(ge)樣(yang)品(pin)后,點擊按(an)鍵開始試(shi)驗(yan)。進(jin)行(xing)(xing)同步投藥,用(yong)(yong)(yong)...

  • 2023-02-17

    ?美(mei)國(guo)食(shi)品(pin)(pin)和(he)(he)藥(yao)物管理局(ju)(FDA)將(jiang)體(ti)外(wai)(wai)-體(ti)內相關(guan)(guan)性(IVIVC)定義為“描述(shu)劑(ji)型(xing)體(ti)外(wai)(wai)特性與相關(guan)(guan)體(ti)內反應之間關(guan)(guan)系(xi)的(de)(de)預(yu)測數學模型(xing)”,IVIVC一直是藥(yao)劑(ji)學領域的(de)(de)熱點,制(zhi)藥(yao)同仁致力于(yu)(yu)(yu)開(kai)發(fa)用(yong)于(yu)(yu)(yu)預(yu)測藥(yao)物產品(pin)(pin)臨(lin)床性能(neng)的(de)(de)體(ti)外(wai)(wai)系(xi)統(tong)和(he)(he)模型(xing)。FDA于(yu)(yu)(yu)1997年發(fa)布了《IVIVC口服緩釋劑(ji)型(xing)開(kai)發(fa)、評估(gu)和(he)(he)應用(yong)的(de)(de)監(jian)管指南(nan)》,盡管尚未發(fa)布針對局(ju)部藥(yao)物產品(pin)(pin)的(de)(de)IVIVC監(jian)管指南(nan),但工業(ye)界已應用(yong)FDA《ER口服劑(ji)型(xing)IVIVC指南(nan)》中的(de)(de)相關(guan)(guan)原則為半固體(ti)制(zhi)劑(ji)產品(pin)(pin)開(kai)發(fa)IVIVC模型(xing),例(li)如通過藥(yao)物體(ti)外(wai)(wai)釋放特性(IVR...

  • 2023-02-14

    自(zi)(zi)動(dong)(dong)取(qu)樣(yang)溶出(chu)系統(tong)可(ke)(ke)同(tong)時進行溶出(chu)試驗(yan),憑借自(zi)(zi)動(dong)(dong)取(qu)樣(yang)儀的(de)高精度可(ke)(ke)實現(xian)(xian)全(quan)自(zi)(zi)動(dong)(dong)過(guo)濾(lv)、取(qu)樣(yang)、補液及稀(xi)釋。產品擁有(you)多(duo)項技術(shu),具有(you)自(zi)(zi)動(dong)(dong)化程(cheng)(cheng)度高、操作(zuo)便捷、功能(neng)(neng)完備(bei)、性能(neng)(neng)穩定等(deng)優點。自(zi)(zi)動(dong)(dong)取(qu)樣(yang)溶出(chu)系統(tong)的(de)特點:(1)可(ke)(ke)選(xuan)攝像頭系統(tong),能(neng)(neng)有(you)效(xiao)觀察和記錄藥(yao)物整個溶出(chu)過(guo)程(cheng)(cheng),為研發和檢測提供重要信息。(2)十二位的(de)溶出(chu)度儀可(ke)(ke)同(tong)時測試12個樣(yang)品,可(ke)(ke)接自(zi)(zi)動(dong)(dong)取(qu)樣(yang)系統(tong),有(you)效(xiao)提高實驗(yan)效(xiao)率(lv)。(3)自(zi)(zi)動(dong)(dong)取(qu)樣(yang)溶出(chu)系統(tong)配備(bei)注射(she)泵、收(shou)集器(qi)以(yi)及控制器(qi),實現(xian)(xian)全(quan)自(zi)(zi)動(dong)(dong)的(de)取(qu)樣(yang)過(guo)程(cheng)(cheng),可(ke)(ke)同(tong)步(bu)投(tou)藥(yao),同(tong)步(bu)自(zi)(zi)動(dong)(dong)清洗管(guan)路(lu)。(4)實現(xian)(xian)2/3區速控,...

  • 2023-02-08

    體(ti)外釋放(fang)試驗(yan)(IVRT)為(wei)評價半(ban)固(gu)體(ti)制劑的(de)(de)藥物釋放(fang)提供(gong)了一種有效的(de)(de)方法(fa),在上(shang)一期我們分享了基于FDAIVRT測試工業指(zhi)南(nan)(nan)(相(xiang)關(guan)閱讀:FDAIVRT測試工業指(zhi)南(nan)(nan)翻譯稿)法(fa)規要(yao)求的(de)(de)理解。為(wei)了增進對該法(fa)規指(zhi)南(nan)(nan)的(de)(de)直觀操(cao)作體(ti)驗(yan),銳(rui)拓儀器參考PotiwaPurazi等的(de)(de)《Assessmentof“Sameness”and/orDifferencesbetweenMarketedCreamsContainingMiconazoleNitrateUsingaDiscriminatoryinv...

  • 2023-01-17

    InVitroPermeationTestStudiesforTopicalDrugProductsSubmittedinANDAsGuidanceforIndustry工(gong)業(ye)指(zhi)南(nan)中ANDAs申請提(ti)交(jiao)的(de)外用制劑的(de)體外滲透試驗研究U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)October2022GenericDrugs美...

  • 2023-01-11

    InVitroReleaseTestStudiesforTopicalDrugProductsSubmittedinANDAsGuidanceforIndustry工業指南中ANDAs申(shen)請遞(di)交的(de)外(wai)用(yong)提交的(de)外(wai)用(yong)制劑的(de)體外(wai)釋放(fang)試驗研究INTRODUCTION緒論(lun)Thisguidanceisintendedtoassistapplicantswhoaresubmittingabbreviatednewdrugapplications(ANDAs)forliquid-basedand...

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