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地址：長(cháng)沙市岳麓區楓林三路500號高盛華成2棟2單元2805
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聯(lián)系人： 15973123761 （尹顯峰）
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我公司自建實(shí)驗室進(jìn)行體外實(shí)驗，與食品藥品監督管理總局核查中心專(zhuān)家，7.22核查帶隊組長(cháng)李正奇博士合作，開(kāi)展BE實(shí)驗。我們以最高標準進(jìn)行BE的數學(xué)模型推導、預BE（動(dòng)物試驗）、正式BE，以確保項目的高通過(guò)率。對于部分產(chǎn)品，可以免BE試驗，大大降低一致性評價(jià)的費用，縮短一致性評價(jià)的時(shí)間。
2016年2月6日，國務(wù)院辦公廳正式發(fā)布了《關(guān)于開(kāi)展仿制藥質(zhì)量與療效一致性評價(jià)的意見(jiàn)》（國辦發(fā)【2016】8號），意見(jiàn)要求，國家基本藥物目錄（2012年版）中2007年10月1日前批準上市的化學(xué)藥品仿制藥口服固體制劑，應在2018年底前完成一致性評價(jià)，其中需開(kāi)展臨床有效性試驗和存在特殊情形的品種，應在2021年底前完成一致性評價(jià)；逾期未完成的，不予再注冊?，F將仿制藥質(zhì)量及療效一致性評價(jià)（以下簡(jiǎn)稱(chēng)仿制藥一致性評價(jià)）的相關(guān)內容介紹如下：
一、什么是仿制藥一致性評價(jià)？
仿制藥一致性評價(jià)，就是將仿制藥與原研藥（參比制劑）通過(guò)體內外實(shí)驗進(jìn)行比較，評估兩者之間的質(zhì)量和療效是否一致。包括以下環(huán)節及內容。
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二、仿制藥一致性評價(jià)的流程。
三、企業(yè)如何應對？
1、仿制藥一致性評價(jià)必須做，國務(wù)院發(fā)文了，不做不行！2、因為時(shí)間緊，要求嚴，相應資源緊缺，企業(yè)越早做越好！
3、在資金緊張的情況下，企業(yè)可以選擇銷(xiāo)量大、利潤高的品種，以及做起來(lái)簡(jiǎn)單，較有把握通過(guò)的品種先做，或者只先做藥學(xué)一致性評價(jià)（體外試驗）。
4、除特大型企業(yè)外，建議企業(yè)最好委托代理公司全過(guò)程負責。企業(yè)不需要招聘專(zhuān)門(mén)從事仿制藥一致性評價(jià)的專(zhuān)業(yè)人員，效率高，總的投入少，通過(guò)評價(jià)的可能性更高。
四、仿制藥一致性評價(jià)所需費用測算
隨著(zhù)做仿制藥一致性評價(jià)的企業(yè)和品種越來(lái)越多，時(shí)間越臨近限定日期，所需費用只會(huì )越來(lái)越高。因產(chǎn)品不同，所需費用相差較大。以易溶的單一成份的化學(xué)藥為例，將所需費用簡(jiǎn)要介紹如下：
（一）、不需做處方及工藝變更的體外實(shí)驗費用（含稅約80萬(wàn)）
（二）、涉及處方及工藝變更的體外實(shí)驗費用（含稅價(jià)200萬(wàn)）
（三）、BE實(shí)驗費用（約需450－500萬(wàn)元，約需6-12個(gè)月）
BE實(shí)驗分為實(shí)驗方案制定、BE備案、BE實(shí)驗操作、資料編寫(xiě)及申報。在具體的實(shí)驗時(shí)，又分篩選期、治療期及隨訪(fǎng)期。篩選期包括篩選日早餐、簽訂知情同意、人口學(xué)資料、病史及用藥史、生命體征、體格檢查、心電圖、病毒學(xué)、血常規、尿常規、血生化、酒精篩查、尿藥檢、X胸片、性激素等檢查，以及血液樣品采集、入排標準審查、一次性耗材等。治療期和隨訪(fǎng)期除了各類(lèi)檢查，還包括醫生觀(guān)察費、護士護理費、夜班費、CRF填寫(xiě)費、專(zhuān)科醫生勞務(wù)費、質(zhì)控服務(wù)費、CRC服務(wù)費、AE/SAE評估費等，另外還有其他費用，包括方案討論修費、制定費、項目管理費、藥物管理費、文件歸檔費、報告管理費、醫院管理費、招募管理費、受試者補償費。
上述各項費用根據品種的不同、以及不同的時(shí)間段進(jìn)行，費用總額會(huì )有調整。如有品種需要進(jìn)行預算，請將品種名稱(chēng)及規格發(fā)給我們，我們給您具體的報價(jià)。
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