References
Bibliographic references:

FDA
  • Guidance for Industry : Analytical Procedures and Methods Validation for Drugs and Biologics, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) July 2015.
  • Guidance for industry: Bioanalytical Method Validation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). 2001 May.
  • Draft Guidance for industry: Bioanalytical Method Validation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). 2013 Sept.
ICH
  • International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology. 2005.
EMA
  • Guideline on Bioanalytical Method Validation, European Medicines Agency (EMA), 2012 February.
USP
  • USP chapter <1225> Validation of Compendial Procedures
  • Draft USP chapter <1210> Statistical tools for procedure validation
ISO
  • ISO 5725-1:1994, Accuracy (trueness and precision) of measurement methods and results -- Part 1: General principles and definitions.
  • 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.
  • ISO 5725-3:1994, Accuracy (trueness and precision) of measurement methods and results -- Part 3: Intermediate measures of the precision of a standard measurement method.
  • ISO 5725-4:1994, Accuracy (trueness and precision) of measurement methods and results -- Part 4: Basic methods for the determination of the trueness of a standard measurement method.
  • ISO 5725-6:1994, Accuracy (trueness and precision) of measurement methods and results -- Part 6: Use in practice of accuracy values.
CLSI-NCCLS
  • EP21-A Estimation of total analytical error for clinical laboratory methods

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