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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="88df3qs" 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>廣東參比制劑定制,參比制劑</p><p><span>***更新：</span>2021-02-01 09:14:32</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="8lp2q2t" 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="h2r79qx" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="hjqpd5x" class="box"><p><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，廣東參比制劑定制。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，廣東參比制劑定制。有關(guān)相關(guān)部門也要抓住這次機(jī)會(huì)盡快確定我國(guó)的參比制劑目錄，廣東參比制劑定制，建立起科學(xué)有效的評(píng)價(jià)指標(biāo)。間隔時(shí)限可根據(jù)參比制劑溶液的具體特性來(lái)確定。廣東參比制劑定制</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑定制,參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637075112069/872295.png"></div><p style="text-indent:25px">參比制劑若同一批次重新標(biāo)定則在原批號(hào)加后綴，例如，1001-1，第二次復(fù)標(biāo)則為1001-2，依次類推。3.內(nèi)部基準(zhǔn)參比制劑按上述原則再加P，例如，P1001。參比制劑有效期（失效期）與復(fù)標(biāo)期無(wú)特殊規(guī)定時(shí)，有效期及復(fù)標(biāo)期如下：1．如無(wú)特殊情況，工作參比制劑的含量每半年復(fù)標(biāo)一次或另取新生產(chǎn)的樣品標(biāo)定。當(dāng)參比制劑暫不使用時(shí)，復(fù)標(biāo)周期可能超過(guò)規(guī)定周期，在使用前進(jìn)行復(fù)標(biāo)，合格后可以繼續(xù)使用。2.對(duì)于特定市場(chǎng)使用的工作參比制劑，復(fù)標(biāo)可以按照當(dāng)?shù)厮幷只蛘咚幍涞囊?guī)定的周期來(lái)進(jìn)行。廣東參比制劑定制參比制劑的具有比較穩(wěn)定的性質(zhì)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑定制,參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637049594164/565484.png"></div><p style="text-indent:25px">參比制劑應(yīng)與一致性評(píng)價(jià)品種名單的品種規(guī)格核對(duì)后，按照食品藥品監(jiān)管總局《關(guān)于研制過(guò)程中所需研究用中間藥品一次性進(jìn)口有關(guān)事宜的公告》的要求，采用一次性進(jìn)口的方式進(jìn)行。委托第三方購(gòu)買。鼓勵(lì)擁有進(jìn)出口資質(zhì)的第三方貿(mào)易公司提供參比制劑采購(gòu)服務(wù)。食品藥品監(jiān)管總局也可公開(kāi)已獲得的參比制劑相關(guān)信息，供企業(yè)參考。協(xié)助企業(yè)購(gòu)買。特殊品種、通過(guò)市場(chǎng)途徑無(wú)法購(gòu)買的品種，可由食品藥品監(jiān)管總局通過(guò)相關(guān)單位間合作渠道與原研企業(yè)協(xié)商等方式，協(xié)助企業(yè)購(gòu)買。</p><p style="text-indent:25px">參比制劑保存于冰箱冷藏室。3.-20度冷凍：用于化學(xué)性質(zhì)不穩(wěn)定，常溫下容易分解的物質(zhì)。-80度保存：一些具有生物活性的物質(zhì)，需要保存于特定的-80度的冰箱。運(yùn)輸條件：相對(duì)于長(zhǎng)期保存的條件，運(yùn)輸過(guò)程由于時(shí)間比較短，所以運(yùn)輸條件相對(duì)來(lái)說(shuō)要求沒(méi)有保存條件那么嚴(yán)格。長(zhǎng)期保存條件為常溫和+4度的參比制劑都可以在常溫條件下運(yùn)輸，-20度保存的參比制劑在運(yùn)輸時(shí)可以放入冰袋來(lái)降低溫度，而-80度保存的物質(zhì)則需要在運(yùn)輸時(shí)加入干冰。但是干冰的有效時(shí)間只能維持1天左右。參比制劑在藥品檢驗(yàn)中具有十分重要的地位。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑定制,參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637060560988/9625529.png"></div><p style="text-indent:25px">附有證書的參比制劑，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、已知光密度的玻璃組裝成透射濾光片、尺寸均勻的球狀顆粒安放在顯微鏡載片上，有證參比制劑的特性有時(shí)可方便和可靠地確定。參比制劑若用于含量測(cè)定，應(yīng)啟開(kāi)后立即使用。廣東參比制劑定制</p><p style="text-indent:25px">參比制劑的功能是檢測(cè)藥品是否符合質(zhì)量。廣東參比制劑定制</p><p style="text-indent:25px">可以認(rèn)為參比制劑是有證參比制劑的重要組成部分。為使研制（生產(chǎn)）認(rèn)定機(jī)構(gòu)與使用者之間的這種信息傳遞方式更加有效，認(rèn)定者發(fā)布的信息能夠滿足使用者的要求，國(guó)際標(biāo)準(zhǔn)化組織/參比制劑會(huì)（ISO/REMCO）制訂了有證參比制劑證書的定義和有關(guān)參比制劑證書的指南ISO指南31。注2是對(duì)有證參比制劑的制備（生產(chǎn)）方式、定值測(cè)量原理和要求進(jìn)行了一個(gè)簡(jiǎn)單的陳述，關(guān)于這些方面的更具體的描述和要求可以參考相關(guān)指南?，F(xiàn)行的sI單位制并不能覆蓋所有分析測(cè)量。廣東參比制劑定制</p></p><br /><p>文章來(lái)源地址: 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