20xx年醫(yī)學(xué)專題—usp40-1225--藥典的驗(yàn)證中英文對(duì)照(編輯修改稿)
2024-11-19 04:46 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 ial (see below inData Elements Required for Validation).如果是藥典方法，下面的一些情況下有必要進(jìn)行再驗(yàn)證：將修改的分析方法遞交給USP；或者將擬定的關(guān)于新產(chǎn)品或原輔料總的分析方法的使用〔見如下驗(yàn)證需要的資料組成〕The ICH documents give guidance on the necessity for revalidation in the following circumstances: changes in the synthesis of the drug substance。 changes in the position of the drug product。 and changes in the analytical procedure.ICH文件給出下面的情況需要再驗(yàn)證：藥品合成的變更；藥品成分的變更；分析方法的變更。Chapter?1225?isintendedtoprovideinformationthatis appropriatetovalidateawiderangeofpendialanalyticalprocedures.Thevalidationofpendialprocedures may use someorallof the suggested typicalanalyticalcharacteristicsusedinmethodvalidationasoutlinedinTable1andcategorizedbytypeofanalyticalmethodinTable2. For some pendialproceduresthefundamentalprinciples of validation may extend beyondcharacteristicssuggested in Chapter?1225?.Fortheseprocedures theuserisreferred to the individualpendialchapterforthosespecific analyticalvalidationcharacteristicsandanyspecificvalidation.第1225章的目的是提供適當(dāng)?shù)男畔ⅲ则?yàn)證大范圍的藥典分析方法。藥典里的方法驗(yàn)證可能會(huì)用一些或者全部的在表1和表2中列出的典型分析特性。對(duì)于一些藥典方法，驗(yàn)證的根本原那么可能超出了1225章所示的特性。對(duì)于這些方法，使用者可以參考單獨(dú)藥典章節(jié)，這些章節(jié)表達(dá)的是特定的分析驗(yàn)證特性和特定的驗(yàn)證。Analytical Performance Characteristics分析性能特征accuracy準(zhǔn)確度Definition—The accuracy of an analytical procedure is the closeness of test results obtained by that procedure to the true value. The accuracy of an analytical procedure should be established across its range. [Anoteonterminology:Thedefinitionofaccuracyin?1225?andICHQ2correspondstounbiasednessonly.IntheInternationalVocabularyofMetrology(VIM)anddocumentsoftheInternationalOrganizationforStandardization(ISO),“accuracy〞hasadifferentmeaning.InISO,accuracybinestheconceptsofunbiasedness(termed“trueness〞)andprecision.]定義分析方法的準(zhǔn)確度是采用分析方法獲得的檢測(cè)結(jié)果和真實(shí)值之間的接近程度。分析方法的準(zhǔn)確度應(yīng)在其范圍中建立。關(guān)于術(shù)語(yǔ)的注釋:1225的準(zhǔn)確性的定義和ICHQ2符合于不偏性。在國(guó)際計(jì)量學(xué)(VIM)和國(guó)際標(biāo)準(zhǔn)化組織(ISO)的文獻(xiàn)中，“準(zhǔn)確性〞有區(qū)別。在ISO中，準(zhǔn)確性的概念融合了不偏性〔術(shù)語(yǔ)來(lái)講“真實(shí)性〞和精確性〕。Determination—In the case of the assay of a drug substance, accuracy may be determined by application of the analytical procedure to an analyte of known purity (., a Reference Standard) or by parison of the results of the procedure with those of a second, wellcharacterized procedure, the accuracy of which has been stated or defined.測(cè)定如果是藥品的含量測(cè)定，準(zhǔn)確度可以通用采用分析方法對(duì)純度〔如對(duì)照品〕的測(cè)定來(lái)確定，也可以通過(guò)和使用其它的第二個(gè)完好的方法〔其準(zhǔn)確度已說(shuō)明或確定〕的結(jié)果比擬來(lái)確定。In the case of the assay of a drug in a formulated product, accuracy may be determined by application of the analytical procedure to synthetic mixtures of the drug product ponents to which known amounts of analyte have been added within the range of the procedure. If it is not possible to obtain samples of all drug product ponents, it may be acceptable either to add known quantities of the analyte to the drug product (., “to spike〞) or to pare results with those of a second, wellcharacterized procedure, the accuracy of which has been stated or defined.如果對(duì)某一劑型的產(chǎn)品的含量測(cè)定，準(zhǔn)確度可以通過(guò)采用分析方法對(duì)參加量的分析物〔在方法的范圍內(nèi)〕的制劑組分的合成混合物進(jìn)行測(cè)定。假設(shè)不可以獲得所有制劑組分的樣品，要么通過(guò)在制劑中參加量的分析物〔如，加樣〕是可以接受的，要么和第二個(gè)完好的方法〔準(zhǔn)確度已說(shuō)明或確定〕的結(jié)果來(lái)比擬。In the case of quantitativ
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