References

Belanger, B.A., Davidian, M., Giltinan, D.M. (1996). "The effect of variance function estimation on nonlinear calibration inference in immunoassay data." Biometrics. 52, 158–175.

Boulanger, B., Hubert, P., Chiap, P., Dewé, W. (2000a). "Objectives of pre-study validation and decision rules." Presented at AAPS APQ Open forum, Indianapolis, Indiana.

Boulanger, B., Hubert, P., Chiap, P., Dewé, W., Crommen, J. (2000b). "Analyse statistique des résultats de validation de méthodes chromatographiques." Presented at Journées du GMP, Bordeaux, France.

DeSilva, B., Smith, W., Weiner, R., Kelley, M., Smolec, J., Lee, B., Khan, M., Tacey, R., Hill, H., Celniker, A. (2003). "Recommandations for bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules." Pharmaceutical Research. 20, 1885–1900.

FDA (Food and Drug Administration). (2001). Guidance for industry: Bioanalytical methods validation.

Finney, D. (1978). Statistical Methods in Biological Assays. London: Charles Griffin.

Findlay, J.W.A., Smith, W.C., Lee, J.W., Nordblom, G.D., Das, I., Desilva, B.S., Khan, M.N., Bowsher, R.R. (2001). "Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective," Journal of Pharmaceutical and Biomedical Analysis. 21, 1249–1273.

Hoffman, D., Kringle, R. (2005). "Two-sided tolerance intervals for balanced and unbalanced random effects models." Journal of Biopharmaceutical Statistics. 15, 283–293.

Hubert, P., Chiap, P., Crommen, J., Boulanger, B., Chapuzet, E., Mercier, N., Bervoas-Martin, S., Chevalier, P. Grandjean, D., Lagorce, P., Lallier, M., Laparra, M.C., Laurentie, M., Nivet, C. (1999). "The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory." Analytica Chimica Acta. 391, 135–148.

Hubert, P. Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivert, C., Valat, L. (2004). "Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal Part I." Journal of Pharmaceutical and Biomedical Analysis. 36, 579–586.

ICH (International Conference on Harmonization). (1995). Guideline on validation of analytical procedures: definitions and terminology.

ICH (International Conference on Harmonization). (1997). Guideline on validation of analytical procedures: methodology.

International Organization for Standardization. ISO 5725-1:1994 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 [Edition 1].

Lee, J.W., Nordblom, G.D., Smith, W.C., Bowsher, R.R. (2003). "Validation of bioanalytical assays for novel biomarkers: Practical recommendations for clinical investigation of new drug entities." Biomarkers in Clinical Drug Development. Bloom, J., Dean, R.A., eds. New York: Marcel Dekker, 119–148.

Mee, R.W. (1984). "β-expectation and β-content tolerance limits for balanced one-way ANOVA pandom model". Technometrics. 26, 251–254.

Mire-Sluis, A.R, Barrett, Y.C., Devanarayan, V., Koren, E., Liu, H., Maia, M., Parish, T., Scott, G., Shankar, G., Shores, E., Swanson, S.J., Taniguchi, G., Wierda, D., Zuckerman, L.A. (2004). "Recommendations for the design of immunoassays used in the detection of antibodies against biological products." Journal of Immunological Methods. 289, 1–16.

O'Connell, M.A., Belanger, B.A., Haaland P.D. (1993). "Calibration and assay development using the four-parameter logistic model." Chemometrics and Intelligent Laboratory Systems. 20, 97–114.

SAS Institute Inc. SAS/STAT User's Guide. Cary, NC: SAS Institute Inc.

Smith, W.C., Sittampalam, S.G. (1998). "Conceptual and statistical issues in the validation of analytical dilution assays for pharmaceutical applications." Journal of Biopharmaceutical Statistics. 8, 509–532.

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