References
Bibliographic references for the Content module (Responses and results mode):
  • Belanger BA, Davidian M, Giltinan DM. The effect of variance function estimation on nonlinear calibration inference in immunoassay data. Biometrics. 1996;52:158-175.
  • Burdik RK, Graybill FA. Confidence interval on variance components. New York: CRC Press;1992.
  • Derringer D, Suich R. Simultaneous optimization of several response variables. Journal of quality technology. 1980;12:214-219.
  • DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, Khan M, Tacey R, Hill H, Celniker A. Recommandations for bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research. 2003;20:1885-1900.
  • Feinberg M, Boulanger B, Dewe W, Hubert P. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Analytical and Bioanalytical Chemistry. 2004;380:502-514.
  • Findlay JWA, Smith WC, Lee JW, Nordblom GD, Das I, Desilva BS, Khan MN, Bowsher RR. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. Journal of Pharmaceutical and Biomedical Analysis. 2001;21:1249-1273.
  • Finney D. Statistical Methods in Biological Assays. London: Charles Griffin;1978.
  • Hubert P, et al. Validation of quantitative analytical procedures. Harmonization of approaches. STP Pharma Pratiques. May-June 2003;13(3):101-138.
  • Lee JW, Smith WC, Nordblom GD, Bowsher RR. Validation of bioanalytical assays for novel biomarkers: practical recommendations for clinical investigation of new drug entities. In: Bloom J, Dean RA, Editors. Biomarkers in Clinical Drug Development. New York: Marcel Dekker. 2003:119-148.
  • Mee RW. Beta-expectation and beta-content tolerance limits for balanced one-way ANOVA random model. Technometrics. 1984;26:251-254.
  • Miller JC, Miller JN. Statistics for Analytical Chemistry. 3rd edn. New York:Ellis Horwood;1993.
  • Miller KJ, Bowsher RR, Celniker A, Gibbons J, Gupta S, Lee JW, Swanson JSJ, Smith WC, Weiner RS. Workshop on Bioanalytical Methods Validation for Macromolecules : Summary Report. Pharmaceutical Research. 2001;18(9):1373-1383.
  • Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design of immunoassays used in the detection of antibodies against biological products. Journal of Immunological Methods. 2004;289(1-2):1-16.
  • O'Connell MA, Belanger BA, Haaland PD. Calibration and assay development using the four-parameter logistic model. Chemometrics and Intelligent Laboratory Systems. 1993;20:97-114.
  • Shah V, Midha K, Findlay J, Hill H, Hulse J, McGilveray I, McKay G, Miller K, Patnaik R, Powell M, Tonelli A, Viswanathan C, Yacobi A. Bioanalytical Method Validation - A revisit with a decade of progress. Pharmaceutical Research. 2000;17(12).
  • Smith WC, Sittampalam SG. Conceptual and statistical issues in the validation of analytical dilution assays for pharmaceutical applications. Journal of Biopharmaceutical Statistics. 1998;8:509-532.
  • Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Workshop/Conference Report — Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays. AAPS Journal. 2007;9(1):E30-E42
  • Eurachem. The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics. 1st edition. Eurachem;1998.
  • Eurachem/CITAC guide.Quantifying Uncertainty in Analytical Measurement. 2nd edition. UK. 2000.
  • Guidance for Industry : Analytical Procedures and Methods Validation (Draft guidance). 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). 2000 August.
  • 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.
  • 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.
  • 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.
Bibliographic references for the Potency module:
  • USP 35 NF 30 S1, U.S. Pharmacopeia, 2012. USP-NF General Chapter <1032> Design and Development of Biological Assays.
  • USP 35 NF 30 S1, U.S. Pharmacopeia, 2012. USP-NF General Chapter <1033> Biological assay validation.
  • USP 35 NF 30 S1, U.S. Pharmacopeia, 2012. USP-NF General Chapter <1034> Analysis of Biological Assays.
  • USP Pharmacopeial Forum 40(5) 2014. In-Process Revision General Chapter <1210> Statistical tool for procedure validation.
  • Belanger BA, Davidian M, Giltinan DM. The effect of variance function estimation on nonlinear calibration inference in immunoassay data. Biometrics. 1996;52:158-175.
  • Derringer D, Suich R. Simultaneous optimization of several response variables. Journal of quality technology. 1980; 12: 214-219.
  • DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, Khan M, Tacey R, Hill H, Celniker A. Recommandations for bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research. 2003; 20: 1885-1900.
  • Feinberg M, Boulanger B, Dewe W, Hubert P. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Analytical and Bioanalytical Chemistry. 2004; 380: 502-514.
  • Findlay JWA, Smith WC, Lee JW, Nordblom GD, Das I, Desilva BS, Khan MN, Bowsher RR. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. Journal of Pharmaceutical and Biomedical Analysis. 2001; 21: 1249-1273.
  • Hauck W.W., Capen R.C., Callahan J.D., De Muth J.E., Hsu H., Lansky D., Sajjadi N.C., Seaver S.S., Singer R.R., Weisman D., Assessing parallelism prior to determining relative potency, PDA J Pharm Sci Technol. 2005 Mar-Apr;59(2):127-137.
  • Hubert Ph et al. Validation of quantitative analytical procedures. Harmonization of approaches. STP Pharma Pratiques. May-June 2003; 13(3): 101-138.
  • Lee JW, Smith WC, Nordblom GD, Bowsher RR. Validation of bioanalytical assays for novel biomarkers: practical recommendations for clinical investigation of new drug entities. Biomarkers in Clinical Drug Development. Bloom J, Dean RA. Eds. Marcel Dekker: New York. 2003; 119-148.
  • Mee RW. Beta-expectation and beta-content tolerance limits for balanced one-way ANOVA random model. Technometrics. 1984; 26: 251-254.
  • Miller K, Bowsher R, Celniker A, Gibbons J, Gupta S, Lee J, Swanson J, Smith W, Weiner R. Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report. Pharmaceutical Research. 2001; 18(9): 1373-1383.
  • Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA. Recommendations for the design of immunoassays used in the detection of antibodies against biological products. Journal of Immunological Methods. 2004; 289(1-2): 1-16.
  • O'Connell MA, Belanger BA, Haaland PD. Calibration and assay development using the four-parameter logistic model. Chemometrics and Intelligent Laboratory Systems. 1993; 20: 97-114.
  • Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, et al. Bioanalytical Method Validation - A revisit with a decade of progress. Pharmaceutical Research. 2000; 17(12): 1551-7.
  • Smith WC, Sittampalam SG. Conceptual and statistical issues in the validation of analytical dilution assays for pharmaceutical applications. Journal of Biopharmaceutical Statistics. 1998; 8: 509-532.
  • Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays. AAPS Journal. 2007; 9(1): E30-E42.
  • Burdik R, Graybill F. Confidence interval on variance components. New York: CRC Press; 1992.
  • Finney D. Statistical Methods in Biological Assays. London: Charles Griffin; 1978.
  • Miller JC, Miller JN. Statistics for Analytical Chemistry. 3rd edn. Ellis Horwood: New York; 1993.
  • Eurachem. The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics. 1st ed. Eurachem; 1998.
  • Eurachem/CITAC guide. Quantifying Uncertainty in Analytical Measurement. 2nd ed. 2000.
  • Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (Draft guidance). 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). 2014 Feb [cited 2015 June 6]. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm386366.pdf.
  • 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 Veterinary Medicine (CVM). 2001 May [cited 2009 Apr 2]. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070107.pdf.
  • 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[cited 2015 June 6]. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm368107.pdf.
  • Guideline on Bioanalytical Method Validation, European Medicines Agency (EMA), 2012 February [cited 2015 June 6].. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
  • CLSI-NCCLS, EP21-A Estimation of total analytical error for clinical laboratory methods.
  • 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 [cited 2009 Apr 2]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm.
  • 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.

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