A Bayesian Approach to Show Assay Equivalence with Replicate Measurements Over a Specified Response Range

Statistics in Biopharmaceutical Research

Volumn 4, Issue 2, 2012, Pages 102-117

  Novick, Steven ^a   Chiswell, Karen ^b   Peterson, John ^a  

^a GLAXOSMITHKLINE   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

Equivalence test; Gibbs sampling; Measurement error; Orthogonal regression

Indexed keywords

POTASSIUM CHANNEL HERG;

ARTICLE; BAYES THEOREM; BIOEQUIVALENCE; DOSE RESPONSE; DRUG ACTIVITY; DRUG DETERMINATION; EXPERIMENTAL DESIGN; HUMAN; IC 50; MICROTITER PLATE ASSAY; NULL HYPOTHESIS; POWER ANALYSIS; PROBABILITY; QT PROLONGATION; REGRESSION ANALYSIS; REPRODUCIBILITY; SAMPLE SIZE; SHORT QT INTERVAL; SIMULATION; STATISTICAL DISTRIBUTION; STATISTICAL MODEL; VARIANCE;

EID: 84865059310     PISSN: None     EISSN: 19466315     Source Type: Journal    
DOI: 10.1198/sbr.2010.09049     Document Type: Article

References (15)

1. Anderson, S. and Hauck, W. 1990. "Consideration of Individual Bioequivalence". Journal of Pharmacokinetics and Biopharmaceutics, 18: 259-273.
2. Carlin, B. P. and Louis, T. A. 2009. Bayesian Methods for Data Analysis, (3rd ed.), Boca Raton, FL: CRC Press.
3. Carroll, R. J. and Ruppert, D. 1996. "The Use and Misuse of Orthogonal Regression in Linear Errors-in-Variables Models". The American Statistician, 50: 1-6.
4. Carroll, R. J., Ruppert, D., Stefanski, L. A. and Crainiceanu, C. M. 2006. Measurement Error in Nonlinear Models: A Modern Perspective (2nd ed.), New York: Chapman and Hall.
5. Dragalin, V. and Fedorov, V. 2001. "The Total Least Squares Method in Individual Bioequivalence Evaluation". Biometrical Journal, 43: 399-420.
6. FDA. 2001. "Guidance for Industry on Statistical Approaches to Establishing Bioequivalence," available online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf
7. Fuller, W. A. 1987. Measurement Error Models, New York: Wiley.
8. Gelman, A., Carlin, J. B., Stern, H. S. and Rubin, D. B. 1995. Bayesian Data Analysis (1st ed.), London: Chapman and Hall.
9. Lin, L. 1989. "A Concordance Correlation Coefficient to Evaluate Reproducibility". Biometrics, 45: 255-268.
10. Lin, L. 2000. "Total Deviation Index for Measuring Individual Agreement with Applications in Laboratory Performance and Bioequivalence". Statistics in Medicine, 19: 255-270.
11. Lin, L., Hedayat, A., Sinha, S. and Yang, M. 2002. "Statistical Methods in Assessing Agreement: Models, Issues, and Tools". Journal of American Statistical Association, 97: 257-270.
12. Lunn, D. J., Thomas, A., Best, N. and Spiegelhalter, D. 2000. "WinBUGS-A Bayesian Modelling Framework: Concepts, Structure, and Extensibility". Statistics and Computing, 10: 325-337.
13. Shao, J. and Zhong, B. 2004. "Assessing the Agreement Between Two Quantitative Assays with Repeated Measurements". Journal of Biopharmaceutical Statistics, 14: 201-212.
14. Sun, D., Whitty, A., Papadatos, J., Newman, M., Donnelly, J., Bowes, S. and Josiah, S. 2005. "Adopting a Practical Statistical Approach for Evaluating Assay Agreement in Drug Discovery". Journal of Biomolecular Screening, 10: 508-516.
15. Tobin, J. 1958. "Estimation of the Relationships for Limited Dependent Variables". Econometrica, 26: 24-36.