分析法の妥当性確認に関するガイダンス >参考文献

参考文献

１）共同試験関連

AOAC Int. (2003). Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis. In Official Methods of Analysis of AOAC Int. 17 ed. volume II, Gaithersburg, MD,USA.

AOAC Int. (1995). AOAC International Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis. J. AOAC Int., 78(5), 143A-160A.

Horwitz, W. (1995). Protocol for the Design, Conduct and Interpretation of Method-Performance Studies. Pure & Appl. Chem., 67(2), 331-343.

ISO (1994). ISO 5725-2:1994. Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method.

JIS (1999). Z 8402-2:1999. 測定方法及び測定結果の精確さ（真度及び精度）−第２部：標準測定方法の併行精度及び再現精度を求めるための基本的方法　[ISO 5725-2:1994に対応]

以下は共同試験に関する最初のガイドライン
[外れ値検定の危険率は1989年または1989年のガイドラインでは1%であったが1995年に2.5%に変更]

Horwitz, W. (1988). Protocol for the Design, Conduct and Interpretation of Collaborative Studies. Pure & Appl. Chem., 60(6), 855-864.

AOAC (1989). Guidelines for Collaborative Study Procedure to Validate Characteristics of a Method of Analysis. J. AOAC, 72(4), 694-704. IUPAC (1988). Pure & Appl. Chem., 60, 855-864.

 

２）技能試験関連

Thompson, M.. and Wood, R. (1993). International Harmonized Protocol for Proficiency Testing of (Chemical) Analytical Laboratories. J. AOAC Int., 76(4), 926-940.

Thompson, M.. and Wood, R. (1993). The International Harmonized Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories. Pure & Appl. Chem., 65(9),2123-2144.

 

３）単一試験室による妥当性確認

Thompson, M., Ellison, S.L..R. and Wood, R. (2002). Harmonized guidelines for single-laboratory validation of methods of analysis. Pure & Appl. Chem., 74, 835-855.

４）内部精度管理

Thompson, M.. and Wood, R. (1995). Harmonized Guidelines for Internal Quality Control in Analytical Chemistry Laboratories. Pure & Appl. Chem., 67(4), 649-666.

 

McClure, F. D. (1990). Design and analysis of qualitative collaborative studies: minimum collaborative program. J. AOAC, 73, 953-960.
[定性試験の共同試験プログラムを提案]

Feldsine, P., Abeyta, C. and Andrews, W.H. (2002). AOAC International Methods Committee Guidelines for Validation of Qualitative and Quantitative Food Microbiological Official Methods of Analysis. J. AOAC Int., 85(5), 1187-1200.
[AOAC公定法の中の食品微生物の定性および定量分析の妥当性確認に関するガイド]

Fleiss, J.L. (1981). Statistical Methods for Rates and Proportions, 2nd Ed., John Wiley & Sons, Inc., New York, NY, pp.6-7.
[McClure (1990)で偽陰性率・偽陽性率の分散の計算式を引用]

Fleiss, J.L., Levin, B., and Paik, M.C. (2003). Statistical Methods for Rates and Proportions, <3rd Ed., John Wiley & Sons, Inc., Hoboken, NJ, p.6.
[偽陰性率・偽陽性率の分散の計算式は名称不適で削除されてます]

Cochran, W.G. (1950). The comparison of percentages in matched samples. Biometrika, 37, 256-266.
[McClure (1990)で引用、CochranのQ検定、定性分析の精度指標（比率）の外れ値検定]

Cochran, W.G. (1977). Sampling Techniques 3rd Ed.. John Wiley & sons, New York.
[McClure (1990)で引用、標本数nの比率のサンプリングによるバイアスは1/n]

Cochran, W.G. (1941). The distribution of the largest of a set of estimated variances as a fraction　of their total. Annals of Eugenics, 11, 47-52.
[Cochranの外れ値検定、等分散の検定、定量分析値に関する検定]

Grubbs, F.E. (1950). Sample criteria for testing outlying observations. Ann. Math. Statist. Assn.,　21, 27-58.　
[Grubbsの外れ値検定、定量分析値に関する検定]

Pitman, E.J.G. (1939). A note on normal correlation. Biometrika, 31, 9-12.
[Youdenペアの等分散の検定、定量分析値に関する検定]

 

FAPAS (2002). Food Analysis Performance Assessment Scheme (FAPAS) protocol for the organisation and analysis of data 6th ed., FAPAS central science laboratory, UK.

Analytical Methods Committee (1989). Robust statistics - how not to reject outliers. Part 1. basic concepts. Analyst, 114, 1693-1697.
[ロバストな平均値と標準偏差の計算、HuberのH15法]

Fearn, T. and Thompson, M. (2001). A new test for 'sufficient homogeneity'. Analyst, 126, 1414-1417.
[配付試料の均一性確認テスト、分析誤差の小さい分析法への対応]

Williams, J.S. (1962). A confidence interval for variance components. Biometrika, 49, 278-281.
[Fearn and Thompson (2001)が信頼区間の計算法としてこの文献を引用]

広津千尋(1992). 実験データの解析 -分散分析を超えて-. 共立出版, 東京,pp.281-285.
[Williams (1962)の信頼区間計算法の説明あり]

Calbiani, F., Careri, M., Elviri, L., Mangia, A. and Zagnoni, I. (2004). Development and Single-Laboratory Validation of a Reversed-Phase Liquid Chromatography-Electrospray-Tandem Mass Spectrometry Method for Identification and Determination of Acrylamide in Foods. J. AOAC Int., 87(1), 107-115.
[Single Validationの報告例]

Vander Heyden, Y., Nijhuis, A., Smeyers-Verbeke, J., Vandeginste, B.G.M. and Massart, D.L. (2001). Guidance for robustness/ruggedness tests in method validation. J. Pharmaceutical and Biomedical Analysis, 24, 723-753.
[Single Validationの要求事項にある頑健性（Robustness）のテスト方法]

Horwitz, W., Kamps, L.R. and Boyer, K.W. (1980). Quality control. Quality assurance in the analysis foods for trace constituents. J. AOAC, 63, 1344-1354.

Horwitz, W., Albert, R., Deutsch, M.J. and Thompson, J.N. (1990). Precision　parameters of methods of analysis required for nutrition labeling. part I. J. AOAC, 73, 661-680.

Horwitz, W. and　Albert, R. (1996). Reliability of the determinations of polychlorinated contaminants (biphenyls, dioxins, furans), J. AOAC, Int., 79, 589-621.

Thompson, M. (2000). Recent trends in inter-laboratory precision at ppb and sub-ppb concentrations in relation to fitness for purpose criteria in proficiency testing. Analyst, 125, 385-386.

McClure, F.D. and Lee, J-K (2003). Computation of HORRAT Values. J. AOAC Int.,  86, 1056-1058.

Horwitz, W. and Albert, R. (2004). Letters to the editor. J. AOAC Int., 87(2), 34A.

McClure, F.D. and Lee, J-K (2004). Letters to the editor. J. AOAC Int., 87(2), 35A-40A.

Youden, W.J. and Steiner, E.H. (1975). Statistical Manual of the AOAC. AOAC, USA.

Wernimont, G.T. and Spendley, W. (1987). Use of Statistics to Develop and Evaluate Analytical Methods. AOAC Int., USA.

Miller, J.N. and Miller, J.C. (2000). Statistics and Chemometrics for Analytical Chemistry. 4th ed. Pearson Education Limited, England.

Miller, J.N. and Miller, J.C. (2004). データのとり方とまとめ方 第２版, 宗森信, 佐藤寿邦, 訳, 共立出版, 東京.

Miller, J.N. and Miller, J.C. (1991). データのとり方とまとめ方 分析化学のための統計学 　宗森信, 訳, 共立出版, 東京.

Plackett, R.L. and Burman, J.P. （1946）. The Design of Optimum Multifactorial　Experiments.　Biometrika, 33, 305-325.
[頑健性（Robustness）のテストで用いられる実験計画法の論文]

 

Feldsine, P., Abeyta, C. and Andrews, W.H. (2002). AOAC INTERNATIONAL Methods Committee GuideLines for Validation of Qualitative and Quantitative Food Microbiological Official Methods of Analysis. J. AOAC Int.,85(5), 1187-1200.
[http://www.aoac.org/vmeth/MICGUIDE.PDF から入手可]

Currie, L.A. (1995). Nomenclature in Evaluation of Analytical Methods Including Detection and Quantification Capabilities. Pure & Appl. Chem., 67(10), 1699-1723.

内藤成弘 (2005).　定量分析の試験室間共同試験の設計と解析のポイント. 農林水産省プロジェクト研究「健全な食生活構築のための食品の機能性及び安全性に関する総合研究」, 分析の妥当性確認勉強会資料　 (211KB, A4サイズ24ページ).

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