【正文】 depending upon the type of method involved. However, in most cases a submission will consist of the following sections.將新的或修改后的分析方法遞交至藥典，應(yīng)包含足夠的資料從而使得USP委員會專家和其專家委員會能夠評估擬定方法的價值。extension text, which are concerned with analytical procedures included as part of registration applications submitted within the EC, Japan, and the USA.這一章節(jié)的內(nèi)容盡可能地和ICH文獻(xiàn)“分析方法的驗(yàn)證和方法學(xué)”（文獻(xiàn)與包含在EC，日本和美國遞交的注冊申請中的分析方法相關(guān)）協(xié)調(diào)一致。definitionsare. As notedoutfunction(suchbeobservedreportabletypicalmodels.這些定義指的是“測試結(jié)果”。potential 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。pendialmethodproceduresforTheVocabularydifferent在國際計量學(xué)(VIM)和國際標(biāo)準(zhǔn)化組織(ISO)的文獻(xiàn)中，“準(zhǔn)確性”有區(qū)別。0，來設(shè)定可接受標(biāo)準(zhǔn)是不被接受的。Data Elements Required for Validation驗(yàn)證需求數(shù)據(jù)組成Compendial test requirements vary from highly exacting analytical determinations to subjective evaluation of attributes. Considering this broad variety, it is only logical that different test procedures require different validation schemes. This chapter covers only the most mon categories of tests for which validation data should be required. These categories are as follows:法定的檢測要求從高度萃取的分析測定到特征的主觀評價變化。check for your question in the FAQs其可以評估?；蛱娲摹nd(ISO),only.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. [Aismethodanalyticala In the case of pendial procedures, revalidation may be necessary in the following cases: a submission to the USP of a revised analytical procedure。ofuseinvolve the assessment of the chemometriccancan be a resultrequirebecharacteristicresultsTable 1. Because opinions may differ with respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be measured.分析方法的驗(yàn)證是一個過程：通過實(shí)驗(yàn)室的研究確立了方法的性能參數(shù)可以滿足預(yù)期的分析應(yīng)用的要求。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documentsUSP and對于已修改的方法，需比較當(dāng)前方法的局限性和擬定方法的優(yōu)點(diǎn)。of35341,specifythe standardstandardthe observedpare tovalidation因此，一個測試結(jié)果可以是由幾個測定值計算出來的結(jié)果。shouldtovalidationTablesuggested in Chapterand?1225?documentsbinesIn the case of quantitative analysis of impurities, accuracy should be assessed on samples (of drug substance or drug product) spiked with known amounts of impurities. Where it is not possible to obtain samples of certain impurities or degradation products, results should be pared with those obtained by an independent procedure. In the absence of other information, it may be necessary to calculate the amount of an impurity based on parison of its response to that of the drug substance。在本文中，重現(xiàn)性指在不同的實(shí)驗(yàn)室使用分析方法，以共同研究的方式。Category III—Analytical procedures for determination of performance characteristics (., dissolution, drug release).分類 III——用于測量性能特征的分析方法（如，溶出度，藥品釋放）Category IV—Identification tests.分類IV——鑒別試驗(yàn)For each category, different analytical information is needed. Listed in1226因此，成功完成這些研究的文件是確定方法是否適用的基本要求。are data elements that are normally required for each of these categories.對于每一分類，需要不同的分析資料資料。重復(fù)性指的是在同一實(shí)驗(yàn)室內(nèi)，一小段時間內(nèi)，由同一實(shí)驗(yàn)人員在相同的設(shè)備上進(jìn)行分析。在不可以獲得某些雜質(zhì)或降解產(chǎn)物的樣品情況下，結(jié)果可以和獨(dú)立的方法獲得的結(jié)果比較。conceptstheICHspecificcategorizedpendialinformation