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class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)格要求：</span>面議</p><p><span>所在地：</span>廣東省</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>廣東參比制劑報(bào)價(jià),參比制劑</p><p><span>***更新：</span>2020-12-02 02:16:30</p><p><span id="click" >瀏覽次數(shù)：12次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="su3jlik" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">深圳振強(qiáng)生物技術(shù)有限公司</a></p><p><span>聯(lián)系人：</span>顏佳</p><p><span>郵箱: </span>450804601@qq.com</p><p><span>電話: </span>15920483169</p><p><span>傳真: </span>0755_</p><p><span>網(wǎng)址: </span>http://www.chem-strong.com</p><p><span>手機(jī): </span>0755-66853366</p><p><span>地址: </span>龍崗街道南聯(lián)社區(qū)碧新路(龍崗段)2055號(hào)1201</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="kpzwyfc" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="zogd89r" class="box"><p><p style="text-indent:25px">附有證書(shū)的參比制劑，其一種或多種特性量值用建立了溯源性的程序確定，使之可溯源到準(zhǔn)確復(fù)現(xiàn)的表示該特性值的測(cè)量單位，每一種認(rèn)定的特性量值都附有給定置信水平的不確定度。有證參比制劑一般成批制備，其特性量值是通過(guò)對(duì)表示整批物質(zhì)的樣品進(jìn)行測(cè)量而確定，并具有規(guī)定的不確定度。當(dāng)物質(zhì)與特制的器件結(jié)合時(shí)，例如，已知三相點(diǎn)的物質(zhì)裝入三相點(diǎn)瓶，廣東參比制劑報(bào)價(jià)、已知光密度的玻璃組裝成透射濾光片，廣東參比制劑報(bào)價(jià)、尺寸均勻的球狀顆粒安放在顯微鏡載片上，廣東參比制劑報(bào)價(jià)，有證參比制劑的特性有時(shí)可方便和可靠地確定。參比制劑存放要避開(kāi)高溫環(huán)境。廣東參比制劑報(bào)價(jià)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑報(bào)價(jià),參比制劑" src="https://tyunfile.71360.com/WaterMark/UploadFile/SZZQSW/637401868214870069/5825299.png"></div><p style="text-indent:25px">原研國(guó)內(nèi)地產(chǎn)化產(chǎn)品與原研產(chǎn)品工藝等有改變，其生產(chǎn)企業(yè)無(wú)法自證一致性的，需另外確定國(guó)外原研藥品參比制劑。改規(guī)格、改劑型、改鹽基的仿制品種按照《仿制藥質(zhì)量和療效一致性評(píng)價(jià)改規(guī)格藥品評(píng)價(jià)一般考慮》（待發(fā)布）、《仿制藥質(zhì)量與療效一致性評(píng)價(jià)工作中改劑型藥品（普通口服固體制劑）評(píng)價(jià)一般考慮》（待發(fā)布）、《仿制藥質(zhì)量和療效一致性評(píng)價(jià)工作中改鹽基藥品評(píng)價(jià)一般考慮》（待發(fā)布）的要求，選擇參比制劑。企業(yè)自主購(gòu)買(mǎi)。藥品生產(chǎn)企業(yè)是開(kāi)展仿制藥質(zhì)量和療效一致性評(píng)價(jià)工作的主體，應(yīng)自主購(gòu)買(mǎi)參比制劑。廣東參比制劑供應(yīng)參比制劑的檢驗(yàn)效率是很高的。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑報(bào)價(jià),參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637149555117/6501748.png"></div><p style="text-indent:25px">參比制劑具有完整和充分的安全性、有效性數(shù)據(jù)作為上市依據(jù)的藥品。參比制劑的選擇是一致性評(píng)價(jià)中的重要工作，無(wú)論是對(duì)仿制藥的開(kāi)發(fā)還是對(duì)仿制藥的質(zhì)量評(píng)價(jià)，均是基于對(duì)參比制劑的深度解讀。然而，新政還沒(méi)有出參比制劑目錄，劃定的只是參比制劑的選擇范圍。這就要求相關(guān)企業(yè)要主動(dòng)去選擇合適的參比制劑，明確參比制劑信息，做好完成一致性評(píng)價(jià)工作的準(zhǔn)備。有關(guān)相關(guān)部門(mén)也要抓住這次機(jī)會(huì)盡快確定我國(guó)的參比制劑目錄，建立起科學(xué)有效的評(píng)價(jià)指標(biāo)。</p><p style="text-indent:25px">參比制劑的不確定度的來(lái)源包括稱量、儀器、均勻性、穩(wěn)定性、不同實(shí)驗(yàn)室之間以及不同方法所產(chǎn)生的不確定度均需計(jì)算在內(nèi)。(2)均勻性均勻性是物質(zhì)的某些特性具有相同組分或相同結(jié)構(gòu)的狀態(tài)。計(jì)量方法的精密度即標(biāo)準(zhǔn)偏差可以用來(lái)衡量參比制劑的均勻性，精密度受取樣量的影響，參比制劑的均勻性是對(duì)給定的取樣量而言的，均勻性檢驗(yàn)的小取樣量一般都會(huì)在參比制劑證書(shū)中給出。(3)穩(wěn)定性穩(wěn)定性是指參比制劑在指定的環(huán)境條件和時(shí)間內(nèi)，其特性值保持在規(guī)定的范圍內(nèi)的能力。參比制劑具有一個(gè)或多個(gè)準(zhǔn)確測(cè)量的特性量值。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑報(bào)價(jià),參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637060560988/9625529.png"></div><p style="text-indent:25px">參比制劑的貯存不同的參比制劑應(yīng)根據(jù)其理化性質(zhì)、貯存要求的不同選擇適宜的貯存環(huán)境和條件，分別置于規(guī)定的位置。貯存環(huán)境：貯存室應(yīng)盡量設(shè)置空調(diào)設(shè)施，保證室內(nèi)陰涼、干燥、避光、通風(fēng)，溫度在25±5℃，相對(duì)濕度在50～75%為宜。特殊品種要求嚴(yán)格按照規(guī)定的貯存條件妥善保存。參比制劑應(yīng)放在干燥器或其它適宜容器中保存，每一個(gè)干燥器或容器外應(yīng)有區(qū)別于參比制劑編號(hào)的特殊編碼，以示存放位置。干燥器置于**的柜中，依次排列整齊，并由專人管理。參比制劑應(yīng)按說(shuō)明書(shū)規(guī)定的條件妥善保存。廣東參比制劑價(jià)錢(qián)</p><p style="text-indent:25px">參比制劑建議不要再用于含量測(cè)定；廣東參比制劑報(bào)價(jià)</p><p style="text-indent:25px">參比制劑是分析測(cè)量質(zhì)量保證關(guān)心的焦點(diǎn)問(wèn)題。參比制劑所提供特性量值的不確定度必須已知且滿足測(cè)量需求。因此，參比制劑可以按不確定度等級(jí)（越小越好，但評(píng)定必須合理）和依據(jù)不確定度報(bào)告的可靠性和驗(yàn)證結(jié)果進(jìn)行分級(jí)分類。國(guó)際標(biāo)準(zhǔn)化組織（ISO）參比制劑會(huì)編制的ISO導(dǎo)則33——“有證參比制劑的使用”中提出的有證參比制劑在計(jì)量學(xué)中的作用包括：貯存和傳遞特性量值信息根據(jù)定義，一種參比制劑具有一個(gè)或多個(gè)準(zhǔn)確測(cè)量的特性量值。一種有證參比制劑中的特性量值一旦被確定。廣東參比制劑報(bào)價(jià)</p></p><br /><p>文章來(lái)源地址: 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