【正文】 據(jù)和計算的概況、總結(jié)。refer to “testwhatinisanumberastheapplied, suchavalues. Intestvaluepropertyanalytical characteristicsto“分析過程的描述應(yīng)該定義這個過程的測試結(jié)果。然而,用于方法驗(yàn)證中的典型的分析可以應(yīng)用于使用來源于化學(xué)計量模型的那些方法。forobtaining a representative sampleChapteris appropriateanalyticalorvalidationtypethethesethose藥典里的方法驗(yàn)證可能會用一些或者全部的在表1和表2中列出的典型分析特性。definitioncorrespondsofOrganizationmeaning.unbiasedness在ISO中，準(zhǔn)確性的概念融合了不偏性（術(shù)語來講“真實(shí)性”和精確性）。Accuracy is calculated as the percentage of recovery by the assay of the known added amount of analyte in the sample, or as the difference between the mean and the accepted true value, together with confidence intervals.The ICH documents remend that accuracy should be assessed using a minimum of nine determinations over a minimum of three concentration levels, covering the specified range (., three concentrations and three replicates of each concentration).準(zhǔn)確度通過對樣品中已知加入量的分析物的含量測定的回收率來計算，或以平均值和可接受值的差值，以及置信區(qū)間來計算。Determination—The precision of an analytical procedure is determined by assaying a sufficient number of考慮到這一廣泛的變化，不同的檢測方法要求不同的驗(yàn)證項(xiàng)目是合理的。Table 2. Data Elements Required for Validation表2 驗(yàn)證需求的資料組成AnalyticalPerformanceCharacteristics分析性能參數(shù)Category I分類ICategory II分類IICategory III分類IIICategory IV分類IVQuantitative定量LimitTests限度Accuracy準(zhǔn)確度Yes是Yes是**No否Precision精密度Yes是Yes是No否Yes是No否Specificity專屬性Yes是Yes是Yes是*Yes是Detection LimitNoNoYes*NoQuantitation Limit定量限No否Yes是No否*No否Linearity限度Yes是Yes是No否*No否Range范圍Yes是Yes是**No否l見1226。Auxiliary Information— Please 取決于特定檢測的性質(zhì)，可能需要Already established general procedures (., titrimetric determination of water, bacterial endotoxins) should be verified to establish their suitability for use, such as their accuracy (and absence of possible interference) when used for a new product or raw material.對已經(jīng)建立的總的方法（如，水分的滴定測定，細(xì)菌內(nèi)毒素）證明以建立其系統(tǒng)適應(yīng)性，如其準(zhǔn)確度（適當(dāng)干預(yù)的存在），當(dāng)用于新產(chǎn)品或原輔料The validity of an analytical procedure can be verified only by laboratory studies. Therefore, documentation of the successful pletion of such studies is a basic requirement for determining whether a procedure is suitable for its intended application(s). Current pendial procedures are also subject to regulations that require demonstration of suitability under actual conditions of use (see這些分類如下：Category I—Analytical procedures for quantitation of major ponents of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products.分類 I——成品中原料藥的主要組分或活性組分的定量測定的分析方法。621.系統(tǒng)適應(yīng)性檢測是基于設(shè)備，電子，分析操作，和待分析樣品組成了完整的系統(tǒng)。分析方法的精密度通常以一系列測量值的標(biāo)準(zhǔn)偏差或相對標(biāo)準(zhǔn)偏差（變異系數(shù)）來表示。Assessment of accuracy can be acplished in a variety of ways, including evaluating the recovery of the analyte (percent recovery) across the range of the assay, or evaluating the linearity of the relationship between estimated and actual concentrations. The statistically preferred criterion is that the confidence interval for the slope be contained in an interval around , or alternatively, that the slope be close to . In either case, the interval or the definition of closeness should be specified in the validation protocol. The acceptance criterion will depend on the assay and its variability and on the product. Setting an acceptance criterion based on the lack of statistical significance of the test of the null hypothesis that the slope