Enoval - References

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Draft Guidance for industry: Bioanalytical Method Validation.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



		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 Login - About - Minimal Requirements - Features.
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