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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>廣東參比制劑一般在哪里買,參比制劑</p><p><span>***更新：</span>2021-01-31 03:13:42</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="wvx97va" 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="7zqpdzl" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="tcuoac8" class="box"><p><p style="text-indent:25px">可以選擇國際公認(rèn)同種藥物作為參比制劑。選擇未在國內(nèi)上市的藥品品種作為參比制劑，按以下順序進(jìn)行：1.優(yōu)先選擇原研上市許可持有廠家原產(chǎn)地產(chǎn)品。若原研產(chǎn)品有其他產(chǎn)地，該產(chǎn)品須在歐盟、美國、日本上市，廣東參比制劑一般在哪里買，并具有參比制劑地位。2.選擇國際公認(rèn)同種藥物作為參比制劑。原研企業(yè)在中國境內(nèi)生產(chǎn)上市的品種：1.同一條生產(chǎn)線生產(chǎn)的原研國內(nèi)地產(chǎn)化產(chǎn)品，廣東參比制劑一般在哪里買，廣東參比制劑一般在哪里買，同時(shí)在歐盟、美國或日本上市的，由原研企業(yè)提供確證資料，按照《關(guān)于仿制藥質(zhì)量和療效一致性評(píng)價(jià)品種分類的指導(dǎo)意見》。參比制劑的檢驗(yàn)效率是很高的。廣東參比制劑一般在哪里買</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑一般在哪里買,參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637090131358/1400901.png"></div><p style="text-indent:25px">參比制劑遇到測(cè)量溯源性問題時(shí)，就需要尋求其他解決問題的途徑。通常是要看其他國際**機(jī)構(gòu)是否定義并復(fù)現(xiàn)了相應(yīng)的國際單位，如果沒有的話，則要使測(cè)量參考至協(xié)議的有證參比制劑，特定的方法或公議測(cè)量標(biāo)準(zhǔn)。為了在全球取得測(cè)量結(jié)果的溯源性和可比性，國際計(jì)量會(huì)（CIPM）開展的多邊互認(rèn)（MRA）也是按照這一思路進(jìn)行的。計(jì)量作用在分析化學(xué)中，參比制劑是溯源鏈的主要組成單元。因此，它們的計(jì)量學(xué)特征，特別是所提供特性量值的不確定度和在溯源層級(jí)中所處的位置。廣東參比制劑一般在哪里買參比制劑的性質(zhì)是比較穩(wěn)定的。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑一般在哪里買,參比制劑" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395637216000439/3335322.png"></div><p style="text-indent:25px">參比制劑是指用于仿制藥質(zhì)量和療效一致性評(píng)價(jià)的中間藥品，通常為被仿制的對(duì)象，如原研藥品或國際公認(rèn)的同種藥物。參比制劑應(yīng)為工藝合理、質(zhì)量穩(wěn)定、療效確切的藥品。參比制劑是指用于仿制藥質(zhì)量和療效一致性評(píng)價(jià)的中間藥品，通常為被仿制的對(duì)象，如原研藥品或國際公認(rèn)的同種藥物。參比制劑應(yīng)為工藝合理、質(zhì)量穩(wěn)定、療效確切的藥品。仿制藥是指與被仿制藥具有相同的活性成分、劑型、給藥途徑和醫(yī)治作用的藥品。原研藥品是指境內(nèi)外一開始的獲準(zhǔn)上市。</p><p style="text-indent:25px">經(jīng)**會(huì)審核確定和食品藥品監(jiān)管總局發(fā)布后，可選擇為參比制劑。原研國內(nèi)地產(chǎn)化產(chǎn)品與原研產(chǎn)品工藝等均未發(fā)生改變的，由原研企業(yè)提供確證資料，按照品種分類指導(dǎo)意見中所述程序，證明原研國內(nèi)地產(chǎn)化產(chǎn)品與原研藥品質(zhì)量和療效一致的，經(jīng)**會(huì)審核確定和食品藥品監(jiān)管總局發(fā)布后，可選擇為參比制劑。原研國內(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)需證明地產(chǎn)化產(chǎn)品與原研產(chǎn)品質(zhì)量與療效一致后，按照品種分類產(chǎn)品與原研藥品質(zhì)量和療效一致的，經(jīng)**會(huì)審核確定和食品藥品監(jiān)管總局發(fā)布后，可選擇為參比制劑。參比制劑在打開后需要按規(guī)定處理。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東參比制劑一般在哪里買,參比制劑" src="https://tyunfile.71360.com/WaterMark/UploadFile/SZZQSW/637401860355475093/4823827.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，無論是對(duì)仿制藥的開發(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)部門也要抓住這次機(jī)會(huì)盡快確定我國的參比制劑目錄，建立起科學(xué)有效的評(píng)價(jià)指標(biāo)。嚴(yán)格按照化學(xué)參比制劑說明書要求使用和貯存參比制劑。廣東參比制劑平臺(tái)</p><p style="text-indent:25px">參比制劑是藥品檢驗(yàn)的組成部分。廣東參比制劑一般在哪里買</p><p style="text-indent:25px">參比制劑備案與推薦工作，是指藥品生產(chǎn)企業(yè)、行業(yè)協(xié)會(huì)、原研藥品生產(chǎn)企業(yè)、國際公認(rèn)的同種藥物生產(chǎn)企業(yè)等作為申請(qǐng)人或推薦人，參照《普通口服固體制劑參比制劑選擇和確定指導(dǎo)原則》（食品藥品監(jiān)管總局公告），通過備案、推薦、申報(bào)等方式，選擇參比制劑的過程。藥品生產(chǎn)企業(yè)可通過備案的方式選擇參比制劑。生產(chǎn)企業(yè)填寫《參比制劑備案表》；撰寫《綜述資料》，詳述參比制劑選擇理由；提交所生產(chǎn)品種現(xiàn)行有效的批準(zhǔn)證明文件，生產(chǎn)產(chǎn)品初次批準(zhǔn)和上市后變更等歷史沿革情況的說明。廣東參比制劑一般在哪里買</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/3087787.html</p></div></div></div></div></div><div id="irtaco8" 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