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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="3qmijkl" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關鍵詞：</span>山東熙寧生物中心,熙寧生物</p><p><span>***更新：</span>2021-01-28 00:18:27</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="vnjabwm" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">寧波熙寧檢測技術有限公司</a></p><p><span>聯(lián)系人：</span>王蒙</p><p><span>郵箱: </span>meng.wang@accurantbio.com</p><p><span>電話: </span>13585708897</p><p><span>傳真: </span>0574_</p><p><span>網(wǎng)址: </span>https://www.accurantbio.com</p><p><span>手機: </span>0574-87878487</p><p><span>地址: </span>浙江省寧波市鄞州區(qū)聚賢路587弄A5幢4樓</p><p>[當前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="f2urxyj" class="page-proshow02"><p class="title">詳細說明</p><div id="qde2cl7" class="box"><p><p> 介紹對于大分子生物分析方法的驗證策略的思考和建議，山東熙寧生物中心。本文介紹并描述了三個級別的方法驗證策略：即監(jiān)管級驗證，科學級驗證和研究級驗證。這個方法驗證的三級框架概述了，在每個級別的驗證中，應評估的參數(shù)，相應的接受標準，以及所需的文檔記錄；并且，討論了使用何種標準來適當?shù)剡x擇這三個驗證級別中的哪一級。文章介紹的生物分析是指定量地測定在動物和人體體液或組織中的生物藥（本文特指蛋白質類生物藥，包括單抗，細胞因子，生長素，融合蛋白等）的濃度。生物分析方法必須能夠提供滿足下述條件的定量數(shù)據(jù)：基于深度的知識和經(jīng)驗，科學上合理、而且適合其用途。在生物藥開發(fā)的早期階段，滿足一定條件的配體結合式分析方法（ligand-bindingassay，LBA）可用于藥代動力學(PK)的研究中樣本分析，而無需要經(jīng)過由監(jiān)管指南定義的，完整的方法驗證，即監(jiān)管級驗證。**終目的是確保適合其用途的LBA方法能夠支持生物藥開發(fā)所有階段的PK研究。必須說明，山東熙寧生物中心，介紹上述建議和思考是為了引發(fā)討論，希望此文起到分享相關知識與經(jīng)驗，拋磚引玉的目的，引發(fā)更多的相關討論，交流和研究，山東熙寧生物中心。藥物的臨床前和臨床藥代藥效研究的基本邏輯是動物/人體給藥后，監(jiān)控血藥濃度隨時間變化。山東熙寧生物中心</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="山東熙寧生物中心,熙寧生物" src="https://tyunfile.71360.com/WaterMark/UploadFile/Accurantbio/637407924353848375/1132804.png"></div><p> 可能需要更寬泛的接受標準，這一般根據(jù)以下考慮：（1）項目的具體需要；（2）對方法開發(fā)過程中積累的數(shù)據(jù)進行的科學評估；以及（3）如何利用研究中樣本分析數(shù)據(jù)。如果相關決定是在驗證之前作出的，并在計劃中提供了理論依據(jù)和評估時，那么這是可以接受的?；蛘撸梢宰珜懸粋€專門描述需要評估的標準和科學級驗證接受標準的SOP，可以作為上述驗證計劃的替代或補充。如果驗證實驗與SOP中定義的標準不完全一致時，那么在執(zhí)行支持科學級驗證的實驗之前，應在驗證計劃中記錄該偏差和計劃的偏差（planneddeviation）的原因。研究級：不需要正式的SOP或方案來執(zhí)行研究前驗證;但是，建議預先確定要評估的方法參數(shù)和接受標準并記錄下來（在執(zhí)行的每個實驗的目的范圍內(nèi)）。研究報告與存檔/分析方法SOP監(jiān)管級：對于監(jiān)管驗證，在完成研究前驗證和驗證數(shù)據(jù)分析后，需要提交正式報告。此驗證報告將包括執(zhí)行該分析方法的逐步說明，所有相關驗證數(shù)據(jù)存儲位置的列表，以及驗證實驗中方法效能的評估。在研究中樣本分析開始之前，必須有一份詳細的SOP，概述如何使用該方法來確定未知測試樣品的濃度。此外，還必須在SOP中約定允許對研究樣本進行重復分析的標準、如何確定**終報告的結果。浙江熙寧生物行價血樣本凍存進行受體占位分析的試驗方案，可以讓所有臨床受試者的樣品均得到分析，熙寧生物專注于樣品分析。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="山東熙寧生物中心,熙寧生物" src="https://tyunfile.71360.com/WaterMark/UploadFile/Accurantbio/637407924445830738/5452835.png"></div><p> 校準曲線也應該包括至少6個非零校準點濃度。準確度和精密度的偏差和%CV目標均應≤20%（對LLOQ和ULOQ校準點：偏差≤25%，%CV≤25%）。研究前科學級驗證應使用5個級別的QCs(HQC、MQC、LQC、LLOQQC和ULOQQC)；或者，預期研究樣本濃度范圍內(nèi)至少有三個QC濃度；準確度和精密度的目標偏差和%CV：≤20%（LLOQ和ULOQ：偏差≤25%，CV≤25%），HQC、MC和LQC的目標總誤差為≤30%（ULOQQC和LLOQQC為≤40%）。在樣本分析時，應使用三個級別的QCs（HQC、MQC和LQC；復孔分析），準確度和精密度的目標偏差和%CV：≤20%，如果每個校準點（復孔分析）的50%和6個QCs中的至少4個滿足上述接受標準，則該分析運行可以接受。這符合“4-6-20”規(guī)則，也適用于監(jiān)管級驗證的分析方法。應該注意的是，如果在科學級驗證的研究前驗證階段，更寬泛的接受標準被證明是合理的，并適用于STDs和/或QCs的準確性和精密度，那么在樣本分析階段，這些更寬泛的接受標準也應該適用于分析運行的接受。研究級驗證：研究級驗證的準確性和精密度以及STD評估應由一個分析人員在3次**的運行中進行評估。這表示研究級方法驗證的嚴謹性降低了。這是可以接受的，因為它反映了該方法只是有限地用于樣本分析。</p><p> 必須有4個QCs的%CV≤20%。如果在研究前驗證階段使用了更嚴格的接受標準，則在樣本分析期間也必須采用那些標準。表2.對于經(jīng)監(jiān)管級，科學級或研究級驗證的分析方法在研究中樣本分析的接受標準。稀釋線性度監(jiān)管級，科學級或研究級：通常，許多LBA方法的ROQ有限，因此有必要對高濃度樣本進行（多次）稀釋，以使其進入到ROQ之內(nèi)。對于所有級別的驗證，都有必要證明：濃度接近或超過**高劑量水平的預計**大濃度（Cmax），或大于分析方法的既定ULOQ的樣本，可以稀釋進入既定的ROQ。為了評估稀釋線性度，將已知的待測物加入到空白混合樣本基質中，來制備濃度在Cmax或附近（或高于ULOQ）的樣品。然后，稀釋這些“稀釋線性樣品”，使稀釋后的濃度落在ROQ之內(nèi)。如果回算的稀釋前濃度在標稱濃度的20%以內(nèi)，則該方法的稀釋線性度，對于需要進行監(jiān)管驗證的方法，是可以接受的。對于科學級和研究級驗證，可以使用更寬泛的接受標準(即驗收標準與QC樣品相同)。此外，稀釋線性實驗還能夠識別可能的"鉤狀效應"。需要評估這種鉤狀效應（prozoneeffect），以便為研究中樣本分析確立一個合理的稀釋方案。在經(jīng)科學級或研究級驗證的方法支持的研究中，在分析方法規(guī)定的**低稀釋倍數(shù)(MRD)下。多參數(shù)流式細胞術可檢測單個細胞內(nèi)多個細胞因子，并可區(qū)分表達特定細胞因子的細胞亞群，熙寧生物專業(yè)檢測。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="山東熙寧生物中心,熙寧生物" src="https://tyunfile.71360.com/WaterMark/UploadFile/Accurantbio/637407924673369853/9788770.png"></div><p> 以及有關重復分析的文檔記錄。應在研究中樣本分析階段結束時，撰寫正式的生物分析報告，詳細說明該方法的逐步執(zhí)行，提供用于分析的生物藥原液（drugstock）的信息，概述STD和QCs的效能，失敗的分析運行和樣本的列表，記錄重新分析的樣本，和記錄對于驗證過的方法或方法SOP的偏離。研究前監(jiān)管級方法驗證的數(shù)據(jù)和研究中真實樣本生物分析的數(shù)據(jù)的存檔應不晚于研究報告和生物分析報告定稿的時間?？茖W級：建議在完成研究前驗證和驗證數(shù)據(jù)分析后提交報告或總結文檔。該科學級驗證報告或總結應包括方法的逐步執(zhí)行和所有相關數(shù)據(jù)的存儲位置、驗證實驗中方法的效能、研究中樣本分析已確認的接受標準，以及研究中樣本分析計劃（如適用，包括樣本稀釋方案、特定的分析程序、測試樣本驗收標準和允許樣本重復分析的原因）。如果上述所有內(nèi)容都簡明扼要地在總結中列出，則無需有進行正式生物分析的方法SOP；盡管在研究中未知樣本分析的總結文件中，應參考科學級驗證的總結。建議提交一份研究報告，以記錄研究中樣本分析的執(zhí)行情況；這具體取決于數(shù)據(jù)的預定用途，也許不需要。應發(fā)布一份生物分析報告，用于記錄該方法的效能、所有失敗的微孔板、失敗的微孔板/樣本的原因。生物標志物(Biomarker)受體占位(RO)，以及基于流式細胞術(FACS)，熙寧生物專注于臨床大分子檢測。山東熙寧生物排名</p><p style="text-indent:25px">精翰生物通過Jurkat細胞檢測報告基因luciferase的表達，檢測化學發(fā)光信號值，結果顯示正相關。山東熙寧生物中心</p><p> 有限數(shù)量的驗證參數(shù)；如此驗證的生物分析方法可用于PK方法的開發(fā)、研究前方法效能的評估和研究中的樣本分析。根據(jù)藥物開發(fā)不同階段數(shù)據(jù)的預期用途，上述方式很可能是適當?shù)?，并能夠開始有效地彌合開發(fā)生物新藥的需求與不必要地，僵化地應用監(jiān)管準則之間的溝壑。如果正確地運用，這種方式的**終目標是通過加快研發(fā)進程和降低藥物成本，**終使患者受益。應該指出，分級式方式并非對目前對BMV的監(jiān)管準則有異議。事實上，該分級方式反映了小分子生物分析領域的一種普遍做法，即在早期藥物開發(fā)中，應用更有效的驗證工作流程。2.建議的驗證級別:對于研究前方法效能的評估和研究中方法執(zhí)行的意義適合其用途的大分子PK生物分析的方法開發(fā)、效能評價和樣本分析可分為三個級別。其中，要求**嚴格的是生物分析方法的監(jiān)管級驗證，它遵循所有的方法參數(shù)和公認的監(jiān)管指南推薦的接受標準（見擴展閱讀#2-3）。第二級是生物分析方法的科學級驗證，它評估監(jiān)管指南中指定的一些參數(shù)（但不是全部），但很可能有更寬泛的接受標準。第三級是生物分析方法的研究級驗證，它遵循法規(guī)，指南的科學原則，但允許在評估方法參數(shù)和接受標準方面有**大的靈活性。當不需要使用監(jiān)管驗證一個方法時。山東熙寧生物中心</p><p style="text-indent:25px">寧波熙寧檢測技術有限公司是一家一般項目：技術服務、技術開發(fā)、技術咨詢、技術交流、技術轉讓、技術推廣；醫(yī)學研究和試驗發(fā)展；實驗分析儀器銷售；儀器儀表銷售（除依法須經(jīng)批準的項目外，憑營業(yè)執(zhí)照依法自主開展經(jīng)營活動）。許可項目：貨物進出口，技術進出口，進出口代理（依法須經(jīng)批準的項目，經(jīng)相關部門批準后方可開展經(jīng)營活動，具體經(jīng)營項目以審批結果為準）。的公司，是一家集研發(fā)、設計、生產(chǎn)和銷售為一體的專業(yè)化公司。公司自創(chuàng)立以來，投身于生物分析，臨床檢測，生物藥檢測，免疫原性檢測，是醫(yī)藥健康的主力軍。寧波熙寧檢測技術繼續(xù)堅定不移地走高質量發(fā)展道路，既要實現(xiàn)基本面穩(wěn)定增長，又要聚焦關鍵領域，實現(xiàn)轉型再突破。寧波熙寧檢測技術始終關注自身，在風云變化的時代，對自身的建設毫不懈怠，高度的專注與執(zhí)著使寧波熙寧檢測技術在行業(yè)的從容而自信。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/3037790.html</p></div></div></div></div></div><div id="u2788g3" class="page-right twoColRt"><div id="cek8jf7" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="jhtpbxo" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強信息推薦自業(yè)物資供應" class="vcenter" 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