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- Analytical Procedures must be Validated. 分析操作規程必須經(jīng)過(guò)驗證。
- A detailed description of the analytical procedures used to characterize the reference standard. 用于界定標準品的分析程序的詳細敘述。
- All chromatographic analytical procedures should include system suitability testing and criteria. 所有的色譜分析方法都應當要有系統適應性實(shí)驗及相應的合格標準。
- FDA intends to provide guidance in the future on postapproval changes in analytical procedures. FDA打算在將來(lái)要提供分析方法批準后變更方面的指南。
- Analytical procedures outside the scope of the ICH guidances should still be validated. 對于超出ICH指導原則范圍的分析方法也是需要驗證的。
- The review chemist evaluates the analytical procedures and validation data submitted in the NDA or ANDA. 審評化學(xué)家會(huì )對NDA或ANDA中的分析方法和驗證資料進(jìn)行評審。
- The principles, analytical procedures and calculation of the method were introduced. 介紹了該方法的原理、分析步驟及計算方法。
- Biological and/ or immunochemical activity should be assessed using the same analytical procedures used to determine product potency. 確定生物和/免疫化學(xué)活性的分析方法應當要和用來(lái)確定產(chǎn)品效力的分析方法一樣。
- The review committee chair may request analytical testing by CBER laboratory analysts to evaluate the applicant=s analytical procedures and verify the test results. 評審委員會(huì )主席會(huì )要求CBER實(shí)驗室的分析人員進(jìn)行分析實(shí)驗對申請者的分析方法進(jìn)行評估，并確認其分析結果。
- Biological and/or immunochemical activity should be assessed using the same analytical procedures used to determine product potency. 確定生物和/或免疫化學(xué)活性的分析方法應當要和用來(lái)確定產(chǎn)品效力的分析方法一樣。
- A description of analytical procedures from any other published sources should be provided, because the referenced sources may not be readily accessible to the reviewer. 對于從其它公開(kāi)發(fā)表的文獻上獲得的分析方法，應當要對其進(jìn)行敘述，因為評審官可能并不能很方便的獲得這些文獻。
- All analytical procedures should be fully developed and validation completed when the NDA, ANDA, BLA, or PLA is submitted. 在遞交NDA，ANDA，BLA或PLA時(shí)，所有的分析方法都應當要開(kāi)發(fā)出來(lái)，并得到驗證。
- In general, validated analytical procedures should be used, irrespective of whether they are for in-process, release, acceptance, or stability testing. 一般來(lái)說(shuō)，應當要應用已驗證過(guò)的分析方法，而不論其是被用于過(guò)程控制，放行，合格或穩定性實(shí)驗。
- Analytical procedures should be performed early in the audit so to help the auditor determine areas that need to be more thoroughly investigated. 該步驟應在審計的早期進(jìn)行，以便審計師能決定哪些關(guān)鍵區域需要更透徹的審查。
- The review chemists and laboratory analysts determine the suitability of the analytical procedures for regulatory purposes. 審評化學(xué)家和實(shí)驗室分析家會(huì )從法規的角度確定該分析方法的適用性。
- Data must be available to establish that the analytical procedures used in testing meet proper standards of accuracy and reliability (21 CFR 211.165(e) and 211.194(a)(2)). 必須要有資料來(lái)論證所用的分析方法是符合一定的準確度和可靠性標準的。
- He tried to put a bold face on his failure. 他對自己的失敗裝出一副滿(mǎn)不在乎的樣子。
- The cake we made was somewhat of a failure. 我們做的蛋糕不大成功。
- METHODS:Based on the requirements on drug registration in Europe and the USA,we expounded the validation on analytical procedures and put forward some concrete methods. 方法:結合歐美原料藥注冊管理的要求,對其中的分析方法驗證部分進(jìn)行全面闡述,并提出具體的操作方法。
- For BLAs, PLAs, and their supplements, the analytical procedures and their validation are submitted as part of the license application or supplement and are evaluated by the review committee. 對于BLA，PLA及它們的補充，在所提交的許可證申請中應當要有分析方法和方法驗證這部分的資料，審評委員會(huì )會(huì )對這部分資料進(jìn)行評審。
