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Article(id=1241779358482894976, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1241779355555266850, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024.05.21, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1700409600000, receivedDateStr=2023-11-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773992870207, onlineDateStr=2026-03-20, pubDate=1717084800000, pubDateStr=2024-05-31, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773992870207, onlineIssueDateStr=2026-03-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773992870207, creator=13701087609, updateTime=1773992870207, updator=13701087609, issue=Issue{id=1241779355555266850, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='5', pageStart='737', pageEnd='920', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773992869509, creator=13701087609, updateTime=1773992925624, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241779590985749489, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1241779355555266850, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241779590985749490, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1241779355555266850, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=916, endPage=920, ext={EN=ArticleExt(id=1241779358835216517, articleId=1241779358482894976, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Discussion the ongoing verification indicators and evaluation approachs of analytical procedure, columnId=1206272758774821315, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Standard Deliberation, runingTitle=null, highlight=null, articleAbstract=

Ongoing procedure performance verification (OPPV) of an analytical procedure is the process of ensuring it continues to meet its intended use after completion of validation. On the basis of previous studies，this paper further discussed the indicators of ongoing procedure performance verification (including system suitability indicators and reported values，etc.) and the implementation of analysis tools (control charts)，and demonstrated the specific operation steps of ongoing procedure performance verification with examples. It is hoped that this paper will provide new ideas for the accurate and standardized procedure verification in the pharmaceutical field，especially in the enterprises and regulatory departments.

, correspAuthors=Xiao-qi NIE, De-jiang TAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Na LI, Ying DU, Ying GENG, Zhao-hui JIN, Xiao-meng QU, Xiao-qi NIE, De-jiang TAN), CN=ArticleExt(id=1241779363004354716, articleId=1241779358482894976, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=分析方法持续确认指标和评估方式的探讨, columnId=1206272758971953622, journalTitle=药物分析杂志, columnName=标准研讨, runingTitle=null, highlight=null, articleAbstract=

分析方法性能持续确认是确保方法在完成验证后持续满足其预期用途的过程。本文在前期研究的基础上，进一步探讨方法性能持续确认的指标（包括系统适用性指标和报告值等）和实施分析工具（控制图），并以示例演示方法性能持续确认的具体操作步骤。希望本文可以为药品领域，特别是企业和监管部门在方法确认的科学化、规范化方面提供新的思路。

, correspAuthors=聂晓齐, 谭德讲, authorNote=null, correspAuthorsNote=
* 聂晓齐　Tel：（010）59613570；E-mail：;
谭德讲　Tel：（010）53851589；E-mail：
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李娜　Tel：1861240509；E-mail：;

杜颖　Tel：（010）53851583；E-mail：

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李娜　Tel：1861240509；E-mail：;

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Validation of Analytical Procedures：Text and Methodology [S]. 2005, articleTitle=null, refAbstract=null), Reference(id=1241779373855019702, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1241779358482894976, doi=null, pmid=null, pmcid=null, year=2021, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=PA/PH/OMCL (21) 26-Statistical analysis of results using CombiStats [EB/OL]. 2021 [2022-05-30]. https://www.edqm.eu/documents/52006/67492/Statistical+analysis+of+results+of+biological+assays+and+tests+-+PA_PH_OMCL+%2821%29+26.pdf/9281bbf2-f852-d0f5-9342-95ff25397946?t=1649409069892, articleTitle=PA/PH/OMCL (21) 26-Statistical analysis of results using CombiStats, refAbstract=null), Reference(id=1241779374018597567, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1241779358482894976, doi=null, pmid=null, pmcid=null, year=2020, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=ASTM D6299. Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance[S]. 2020, articleTitle=null, refAbstract=null), Reference(id=1241779374182175432, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1241779358482894976, doi=null, pmid=null, pmcid=null, year=2023, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=ISO 7870-2. 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The results of 3 repeated tests on 25 samples

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样品号
（sample number）		结果1
（result 1）		结果2
（result 2）		结果3
（result 3）
116.07616.07316.083
216.07316.06616.078
316.07516.0716.079
416.07716.07216.079
516.07116.06516.070
616.07016.05816.083
716.07716.07216.081
816.07416.06116.086
916.07016.06516.074
1016.07416.06116.086
1116.07716.07316.082
1216.02716.03116.022
1316.07716.06616.089
1416.06916.06516.077
1516.07216.06616.085
1616.07516.06316.084
1716.07516.07116.088
1816.07316.06416.081
1916.07516.06316.098
2016.07516.05616.089
2116.07316.06616.083
2216.07416.06316.088
2316.07116.06416.081
2416.07616.06916.086
2516.07216.06316.081
), ArticleFig(id=1241779369765573133, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1241779358482894976, language=CN, label=表1, caption=

25个样品的3次重复测定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
样品号
（sample number）		结果1
（result 1）		结果2
（result 2）		结果3
（result 3）
116.07616.07316.083
216.07316.06616.078
316.07516.0716.079
416.07716.07216.079
516.07116.06516.070
616.07016.05816.083
716.07716.07216.081
816.07416.06116.086
916.07016.06516.074
1016.07416.06116.086
1116.07716.07316.082
1216.02716.03116.022
1316.07716.06616.089
1416.06916.06516.077
1516.07216.06616.085
1616.07516.06316.084
1716.07516.07116.088
1816.07316.06416.081
1916.07516.06316.098
2016.07516.05616.089
2116.07316.06616.083
2216.07416.06316.088
2316.07116.06416.081
2416.07616.06916.086
2516.07216.06316.081
), ArticleFig(id=1241779370042397209, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1241779358482894976, language=EN, label=Tab.2, caption=

Mean square errors and RSD

, figureFileSmall=null, figureFileBig=null, tableContent=
验证试验序号
（No. of assay）		MSERSD/%验证试验序号
（No. of assay）		MSERSD/%
A011.2235.9A160.834.9
A021.0335.3A171.8537.5
A030.9514.9A182.6858.3
A041.4386.3A191.2555.9
A051.9377.5A201.4756.5
A060.3663.2A210.834.9
A071.6996.6A221.1315.4
A081.556.4A232.2548.3
A090.9394.9A240.9394.8
A100.8935.0A251.1455.6
A110.4943.7A261.0015.1
A121.5286.7A271.9377.3
A130.4523.5A281.0835.2
A143.73510.0A291.0435.5
A150.7524.6A300.4273.5
), ArticleFig(id=1241779371577512480, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1241779358482894976, language=CN, label=表2, caption=

MSE和RSD

, figureFileSmall=null, figureFileBig=null, tableContent=
验证试验序号
（No. of assay）		MSERSD/%验证试验序号
（No. of assay）		MSERSD/%
A011.2235.9A160.834.9
A021.0335.3A171.8537.5
A030.9514.9A182.6858.3
A041.4386.3A191.2555.9
A051.9377.5A201.4756.5
A060.3663.2A210.834.9
A071.6996.6A221.1315.4
A081.556.4A232.2548.3
A090.9394.9A240.9394.8
A100.8935.0A251.1455.6
A110.4943.7A261.0015.1
A121.5286.7A271.9377.3
A130.4523.5A281.0835.2
A143.73510.0A291.0435.5
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分析方法持续确认指标和评估方式的探讨
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李娜 1 , 杜颖 2 , 耿颖 2 , 靳朝晖 1 , 曲晓蒙 1 , 聂晓齐 1, * , 谭德讲 2, *
药物分析杂志 | 标准研讨 2024,44(5): 916-920
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药物分析杂志 | 标准研讨 2024, 44(5): 916-920
分析方法持续确认指标和评估方式的探讨
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李娜1 , 杜颖2 , 耿颖2, 靳朝晖1, 曲晓蒙1, 聂晓齐1, * , 谭德讲2, *
作者信息
  • 1.北京民海生物科技有限公司，北京 102609
  • 2.中国食品药品检定研究院 国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629

    • 李娜　Tel：1861240509；E-mail：;

    杜颖　Tel：（010）53851583；E-mail：

通讯作者:

* 聂晓齐　Tel：（010）59613570；E-mail：;
谭德讲　Tel：（010）53851589；E-mail：
Discussion the ongoing verification indicators and evaluation approachs of analytical procedure
Na LI1 , Ying DU2 , Ying GENG2, Zhao-hui JIN1, Xiao-meng QU1, Xiao-qi NIE1, * , De-jiang TAN2, *
Affiliations
  • 1.Beijing Minhai Biotechnology Co., Ltd., Beijing 102609, China
  • 2.National Institutes for Food and Drug Control, NMPA Key Lab for Quality Research and Evaluation of Chemical Drug, Beijing 102629, China
出版时间: 2024-05-31 doi: 10.16155/j.0254-1793.2024.05.21
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摘要
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分析方法性能持续确认是确保方法在完成验证后持续满足其预期用途的过程。本文在前期研究的基础上，进一步探讨方法性能持续确认的指标（包括系统适用性指标和报告值等）和实施分析工具（控制图），并以示例演示方法性能持续确认的具体操作步骤。希望本文可以为药品领域，特别是企业和监管部门在方法确认的科学化、规范化方面提供新的思路。

方法确认  /  方法性能持续确认  /  分析方法全生命周期  /  控制图  /  分析控制属性

Ongoing procedure performance verification (OPPV) of an analytical procedure is the process of ensuring it continues to meet its intended use after completion of validation. On the basis of previous studies，this paper further discussed the indicators of ongoing procedure performance verification (including system suitability indicators and reported values，etc.) and the implementation of analysis tools (control charts)，and demonstrated the specific operation steps of ongoing procedure performance verification with examples. It is hoped that this paper will provide new ideas for the accurate and standardized procedure verification in the pharmaceutical field，especially in the enterprises and regulatory departments.

procedure verification  /  ongoing procedure performance verification  /  analytical procedure life-cycle  /  control chart  /  analytical control attributes
李娜, 杜颖, 耿颖, 靳朝晖, 曲晓蒙, 聂晓齐, 谭德讲. 分析方法持续确认指标和评估方式的探讨. 药物分析杂志, 2024 , 44 (5) : 916 -920 . DOI: 10.16155/j.0254-1793.2024.05.21
Na LI, Ying DU, Ying GENG, Zhao-hui JIN, Xiao-meng QU, Xiao-qi NIE, De-jiang TAN. Discussion the ongoing verification indicators and evaluation approachs of analytical procedure[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (5) : 916 -920 . DOI: 10.16155/j.0254-1793.2024.05.21
正文
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方法性能持续确认（ongoing procedure performance verification，OPPV），是指对方法进行持续监控（ongoing monitoring），确保分析方法在日常使用中能持续可靠地满足其预期用途，进而为产品的质量安全提供保障的分析方式[1-2]。
OPPV是分析方法全生命周期（analytical procedure life-cycle，APL）中的重要环节之一[1]，早在1994年，ISO 5725-6[3]《测量方法与结果的准确度（真实度和精密度）—准确度的实际应用》已经引入了性能特性（performance characteristic）需要长期监控的理念，并对分析方法准确度和精密度的持续稳定程度做了评估；2019年，《中国药品检验标准操作规范》[4]将分析方法的性能属性作为方法持续满足预期用途的指标并提供了相应的示例；2021年，李娜等[5]针对方法确认和转移的评价标准专门进行探讨，并对方法确认评价指标进行了初步说明；2022年，美国药典正式生效<1220> Analytical Procedure Life Cycle [1]（以下简称USP<1220>），从APL角度对方法在日常应用中的持续确认进行了较为详细的探讨，包括：（1）对方法持续监控的意义。通过分析方法持续监控可较早发现分析方法的潜在不利趋势或问题，从而及时改进以确保其满足所需的预期性能；（2）需要监控的基本指标。方法的分析控制属性（analytical control attributes，ACA）；（3）对ACA结果的分析工具。统计过程分析控制图（control chart）。
本文基于USP<1220>，结合统计分析方法，探究药品领域中OPPV的操作要点。首先，对OPPV过程中应选用哪些ACA进行梳理和论证；其次，使用过程控制图对重点关注的ACA进行统计评估；最后，结合日常检验工作收集的数据进行示例演示。希望本文能帮助读者全面掌握分析方法在日常应用中性能持续确认的理论基础和实际操作过程，为监管机构全方位评估分析方法提供有效的工具和手段。
1　分析方法性能持续确认的含义
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分析方法确认包含2个层面的含义：其一，对于一个药典（法定）方法（认为是经过充分验证和多家实验室的确认）初次引入检测实验室的情形，需要根据验证结果数据集中获得的系统适用性指标，或报告值的预测区间和容忍区间来判断确认过程是否符合预期标准，可参考文献《分析方法确认和转移的评估标准探讨》[5]；其二，当实验室长期使用某个分析方法时，对该方法的性能属性不仅需要进行确认，而且需要持续确认。由于方法经历了较长时间的使用过程，实验室可获取较多的历史检测数据，这时，通过选取合适或所关注的ACA进行分析，一方面可以与验证指标（标准）进行比较，以判断其是否持续满足预期用途，另一方面还能得到方法的正常波动范围，并发现是否存在异常波动和性能不足等情况，从而有针对性地采取纠正预防措施（corrective and preventive actions，CAPA），或找到方法需要变更的关键依据。
2　分析方法性能持续确认的指标
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分析方法在经历了方法建立和方法验证后，可确定出检测方法的最佳工作条件和方法性能的正常波动范围。ICH Q14把可以保障方法满足预期用途的技术特性称为分析方法属性（analytical procedure attributes，APA），如方法的系统适用性评估（system suitability testing，SST）指标和方法使用的环境（条件）（也叫方法的参数），并指出这些特性应在验证后确定适当的限度、范围或分布，以确保结果满足预期标准。
为确保方法在使用过程中持续受控且稳定，需要选用合适的分析方法属性作为考察方法性能持续确认的指标进行监控和分析评估，USP<1220>将其称之为ACA。通常将用于性能持续确认的指标划分为以下3类：
2.1　方法的系统适用性指标
系统适用性指标是与方法性能直接相关的ACA。无论是理化分析方法还是生物活性检测分析方法，都需要建立和评估其系统适用性[5]，因此，系统适用性属性可以作为方法持续监控的ACA。常见的评定指标包括质控样品产生的模型总变异（或准确度、精密度）、信噪比、回归模型的残差等[6]。
2.2　报告值
报告值是指与接收标准直接比较的方法检测值[6]，可以作为OPPV中最为直接且有效的ACA [1]。在理化分析方法中，常选用含量或有关物质等检测结果作为报告值；生物活性检测分析中，因效价/滴度能够反映药物对生物受试体产生特定效应的能力，所以是较为常用的报告值[7]。
因为供试品的报告值会同时受到检测方法和产品工艺的变异影响，因此，建议选取同质且可溯源的质控样品的报告值作为ACA。
2.3　其他指标
除了考察系统适用性指标和报告值之外，方法确认过程中还可根据研究者的试验目的，选择其他参数或特性作为分析方法性能持续确认的指标。如对于分析方法/仪器是否持续处于受控状态的评估指标，可以使用方法的操作属性（即方法的参数）。以高效液相色谱法为例，其仪器检测的指标（如分离度、拖尾因子）不仅可以评估其是否满足受控状态，而且还能提示色谱柱是否需要及时更换等[8]61。针对生物活性检测方法，其样品适用性指标（平行性参数）能够判断出样品与参考品间相似性波动范围；常用的ACA包括平行直线的斜率、四参数模型的上下渐近线及斜率、斜率比模型中的截距等[8]206。
3　方法性能持续确认的监控工具—控制图
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控制图（control chart）又叫管制图，是统计过程控制(statistical process control，SPC)中重要的统计工具之一，它是以响应变量对时间作图来监控过程是否处于受控状态的统计分析工具，其控制限的制定基于平均值或目标值周围预期值的分布状态。控制图不仅广泛应用于药品趋势分析和年度回顾报告中[9-10]，也逐渐应用于分析方法持续监控中。
使用控制图的主要原因是无论检测方法设计的多么准确精密，选定的ACA（响应变量）间都必然存在一定的误差。当过程仅由随机误差组成时，可以认为检测方法在统计学上是受控的，ACA值在控制图中居于控制限（一般为目标值±3倍标准差）范围内。反之，若检测过程中存在其他的特殊误差，控制限的建立能很好地检测到特殊（偶然）原因导致的过程变异，例如过程的突变，长期漂移，或噪音过大等。当检测到特殊原因变化时，需要进行调查，以及时确定根本原因和适当的纠正措施。
虽然控制图的绘制较为简单，常规的统计软件或绘图软件均能实现控制图的制作。但需要注意，不仅可以使用ACA的数值结果绘制简单的控制图进行监控，还可以对ACA进行平均（合并）运算绘制均值-标准差控制图等[11-12]。实际应用中针对重复测定数据的平均值和标准偏差等统计量值进行监测；或者对报告值的精密度（常用RSD和GCV作为统计量）也是衡量分析方法是否受控的有效方式。
4　示例
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示例1：实验室在完成方法验证后，检测了后续的25批样品并收集了对应的结果（见表1）[4]，已知每批样品在实验过程中会重复测定3次，通过结果分析该检测方法在使用过程中是否持续稳定。
对表1中3次重复结果绘制均值控制图，详见图1。
从图1可明显看出，样品12的测定过程均值出现了较大的波动，初步推测是由于特殊原因导致的方法变异。后经实验室调查发现本次实验过程是由于仪器更换零件后未调整技术参数，从而导致灵敏度不足所致。本示例可以直观地发现分析过程中的变异和检测结果的异常波动。同时，通过查找变异源并改进异常趋势，既可有效改进检测方法性能，又可提升分析方法控制策略[2]。
示例2：回归模型的均方误差（mean squared errors，MSE）和RSD是一系列描述实验结果准确性和精密性的重要指标[12]。现收集某一生物活性方法经过验证后的30个实验中的回归模型残差的MSE和曲线不同水平下最大组内变异的RSD（表2），通过这些数据试分析该检测方法在日常使用过程中是否满足持续确认的需求。
首先对MSE和RSD做单值移动极差（Individual moving range-ImR）控制图（见图2），图中显示存在失控点（out of point），说明对应的试验（A14）存在较大波动。
通过上述示例可以发现，选取适当的ACA进行控制图分析，能够简单直观地发现过程中的波动和异常情况，可及时提示分析人员发现异常并采取整改措施。特别是在方法性能持续确认过程中，ACA处于持续受控状态，即可证明所使用的方法可持续满足方法的预期用途，又可确保监测分析法的可靠性，为药品的质量安全提供保障。
5　讨论
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5.1　方法性能持续确认的意义
OPPV作为APL中的重要一环，准确有效地实施有以下几方面的优势：第一，有利于及时发现过程的偏离，找出异常出现的原因（如试剂的质量、操作的失误等）并进行纠正和预防行动；第二，利用控制图制定的控制限范围，可以为后期实施等效性检验提供参考，降低因差异性检验导致的结果误判风险等；第三，OPPV可为方法变更提供充分依据。当方法的操作模式（format）改变时，若仍可以满足方法性能持续确认的评价准则，则说明变更前后方法的检测能力仍保持稳定的水平，即可接受操作模式改变带来的影响；最后，对报告值的长期监控可以评估其波动范围，为更科学准确制定产品及方法的质量限度标准奠定了基础。
5.2　控制图的分类和选用规则
控制图的分类依据主要有数据的结构以及分析的目的，一般数据的结构/类型分为计量数据和计数数据2种，对应计量控制图（单值图、均值图、移动极差图等）和计数控制图（NP图、P图等）。在分析方法性能持续确认过程中，考察的ACA测定结果一般为计量数据，故常选用计量控制图，除可使用文中提到的单值-移动极差图外，还可以选用均值-标准差/极差图等[13-14]。在此应注意，单值-移动极差图是由2个图形组成的；单值图描述数据集中趋势的波动情况，移动极差图则是对离散趋势的描述。这2个图形的搭配，可分别从位置-尺度（location-scale）2个方面共同描述数据的趋势变化，从而使方法性能持续确认的分析结果更为合理可靠[14]。
文献
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参考文献 引证文献
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2024年第44卷第5期
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doi: 10.16155/j.0254-1793.2024.05.21
  • 接收时间：2023-11-20
  • 首发时间：2026-03-20
  • 出版时间：2024-05-31
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  • 收稿日期：2023-11-20
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    1.北京民海生物科技有限公司，北京 102609
    2.中国食品药品检定研究院 国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629

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* 聂晓齐　Tel：（010）59613570；E-mail：;
谭德讲　Tel：（010）53851589；E-mail：
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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