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분석법 유효성 확인의 이해와 분야 별 가이드라인 비교

Understanding and comparative analysis of analytical method validation

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참고문헌

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주제분류화학

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Abstract

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참고문헌 (24)

  1. P. L. Garcia, "Analytical Method Validation" (2011), InTech
  2. 분석법검증 지침서 개발 연구, "명승운", 식품의약품안전청, ~ (2011)
  3. Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis, "IUPAC", IUPAC, ~ (2002)
  4. The Fitness for Purpose of Analytical Methods:A Laboratory Guide to Method Validation and Related Topics, "Eurachem", Eurachem, ~ (2014)
  5. "ISO", IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories, International Electrotechnical Commission, pp.2017, ~
  6. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, "ICH Harmonised Guideline: Validation of Analytical Procedures Q2(R2)", ~ (2022)
  7. AOAC International, "Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals", AOAC International, ~ (2002)
  8. 식품의약품안전평가원, "식품등 시험법 마련 표준절차에 관한 가이드라인", ~ (2016)
  9. European Commission, "SANTE", 11312, pp.2021 (2021), ~
  10. Codex Alimentarius Commission, "Procedural Manual 2023", Codex Alimentarius Commission, ~ (2023)
  11. US FDA, "Analytical Procedures and Methods Validation for Drugs and Biologics", ~ (2015)
  12. 식품의약품안전평가원, "의약품 등 시험방법 밸리데이션 가이드라인 해설서", ~ (2015)
  13. WHO Expert Committee, "Specifications for Pharmaceutical Preparations", ~ (2019)
  14. "US Pharmacopeia and national Formulary, USP 47-NF 42, United States Pharmacopeial Convention", ~ (2019)
  15. European Medicines Agency, "Guideline on Bioanalytical Method Validation", ~ (2011)
  16. US FDA, "Bioanalytical Method Validation Guidance for Industry", ~ (2018)
  17. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, "ICH M10: Bioanalytical Method Validation", ~ (2022)
  18. 식품의약품안전평가원, "생체시료 분석법 밸리데이션및 시험 검체 분석 가이드라인", ~ (2023)
  19. 한국인정기구, "화학적 시험방법의 유효성 확인을 위한 지침 KOLAS-G-015", ~ (2020)
  20. Joint Committee for Guides in Metrology, "International Vocabulary of Metrology – Basic and General Concepts and Associated Terms", JCGM, ~ (2012)
  21. J. Vessman, , Pure Appl., Chem, 73(8), pp.1381~1386 (2001)[DOI]
  22. W. Horwitz, , J. AOAC Int, 89(4), pp.1095~1109 (2006)[DOI]
  23. M. Blessy, , J. Pharm. Anal, 4(3), pp.159~165 (2014)[DOI]
  24. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, "ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products Q1A(R2)", ~ (2003)

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