Identification of the Minimum Effective Dose for Normally Distributed Endpoints Using a Model Selection Approach

References

• Akaike, H. (1973), “Information Theory and an Extension of the Maximum Likelihood Principle,” in Second International Symposium on Information Theory, eds. B. N. Petrov and F. Csaki, Budapest, Hungary: Akademiai Kiado, pp. 267–281.
   Google Scholar
• Anraku, K. (1999), “An Information Criterion for Parameters Under a Simple Order Restriction,” Biometrika, 86, 141–152.
   Web of Science ®Google Scholar
• Aras, G., Xue, A., and Liu, T. (2011), “Tukey’s Contrast Test Versus Two-Sample Test in a Dose–Response Clinical Trial,” Statistics in Biopharmaceutical Research, 3, 31–39.
   Web of Science ®Google Scholar
• Bauer, P. (1997), “A Note on Multiple Testing Procedures in Dose Finding,” Biometrics, 53, 1125–1128.
   PubMed Web of Science ®Google Scholar
• Bretz, F. (1999), Powerful Modification of Williams Test on Trend, unpublished PhD thesis, Leibniz University.
   Google Scholar
• Bretz, F., Hothorn, T., and Westfall, P. (2002), “On Multiple Comparisons in R,” R News, 2, 14–17.
   Google Scholar
• Cohen, J. (1992), “A Power Primer,” Psychological Bulletin, 112, 155–159.
   PubMed Web of Science ®Google Scholar
• Committee for Proprietary Medicine Products (2002), “Points to Consider on Multiplicity Issues in Clinical Trials,” Technical Report, CPMP/EWP/908/99.
   Google Scholar
• Dilba, G., Bretz, E., Guiard, V., and Hothorn, L.A. (2004), “Simultaneous Confidence Intervals for Ratios With Applications to the Comparison of Several Treatments With a Control,” Methods of Information in Medicine, 43, 465–469.
   PubMed Web of Science ®Google Scholar
• Dunnett, C.W. (1955), “A Multiple Comparison Procedure for Comparing Several Treatments With a Control,” Journal of the American Statistical Association, 50, 1096–1121.
   Web of Science ®Google Scholar
• Fitzhugh, O.G., Nelson, A.A., and Quaife, M.L. (1964), “Chronic Oral Toxicity of Aldrin and Dieldrin in Rats and Dogs,” Food Cosmetic Toxicology, 2, 551–562.
   PubMedGoogle Scholar
• Genz, A., and Bretz, F. (1999), “Numerical Computation of Multivariate t-Probabilities With Application to Power Calculation of Multiple Contrasts,” Journal of Statistical Computation and Simulation, 63, 361–378.
   Web of Science ®Google Scholar
• Hirotsu, C., Yamamoto, S., and Hothorn, L.A. (2011), “Estimating the Dose–Response Pattern by the Maximal Contrast Type Test Approach,” Statistics in Biopharmaceutical Research, 3, 40–53.
   Web of Science ®Google Scholar
• Hothorn, L.A., and Hasler, M. (2008), “Proof of Hazard and Proof of Safety in Toxicological Studies Using Simultaneous Confidence Intervals for Differences and Ratios to Control,” Journal of Biopharmaceutical Statistics, 18, 915–933.
   PubMed Web of Science ®Google Scholar
• Hothorn, L.A., and Hauschke, D. (2000), “Identifying the Maximum Safe Dose: A Multiple Testing Approach,” Journal of Biopharmaceutical Statistics, 10, 15–30.
   PubMedGoogle Scholar
• Hung, H. M.J., and Wang, S.-J. (2010), “Challenges to Multiple Testing in Clinical Trials,” Biometrical Journal, 52, 747–756. . In 6th International Conference on Multiple Comparison Procedures (MCP 2009), Tokyo Univ Sci, Tokyo, Japan, March 24-27, 2009.
   PubMed Web of Science ®Google Scholar
• Kodell, R.L. (2009), “Replace the Noael and Loael With the bmdl(01) and bmdl(10),” Environmental and Ecological Statistics, 16, 3–12.
   Web of Science ®Google Scholar
• Kuiper, R. M. (2011a), Model Selection Criteria: How to Evaluate Order Restrictions,” . unpublished PhD thesis, Utrecht University, 2011.
   Google Scholar
• ——— (2013), “Model Selection Under Inequality Constraints in Small Samples,” . unpublished.
   Google Scholar
• Kuiper, R.M., Hoijtink, H., and Silvapulle, M.J. (2011), “An Akaike-Type Information Criterion for Model Selection Under Inequality Constraints,” Biometrika, 98, 495–501.
   Web of Science ®Google Scholar
• ——— (2012), “Generalization of the Order-Restricted Information Criterion for Multivariate Normal Linear Models,” Journal of Statistical Planning and Inference, 142, 2454–2463.
   Web of Science ®Google Scholar
• Leisenring, W., and Ryan, L. (1992), “Statistical Properties of the Noael,” Regulatory Toxicology and Pharmacology, 15, 161–171.
   PubMed Web of Science ®Google Scholar
• Ruberg, S.J. (1989), “Contrasts for Identifying the Minimum Effective Dose,” Journal of the American Statistical Association, 84, 816–822.
   Web of Science ®Google Scholar
• Sand, S., Portier, C.J., and Krewski, D. (2011), “A Signal-to-Noise Crossover Dose as the Point of Departure for Health Risk Assessment,” Environmental Health Perspectives, 119, 1766–1774.
   PubMed Web of Science ®Google Scholar
• Shang, J. (2010), “A Multiple Comparison Procedure Based on a Variant of the Schwarz Information Criterion in a Mixed Model,” Communications in Statistics Theory and Methods, 39, 1095–1109.
   Web of Science ®Google Scholar
• West, R.W., and Kodell, R.L. (2005), “Changepoint Alternatives to the Noael,” Journal of Agricultural Biological and Environmental Statistics, 10, 197–211.
   Google Scholar
• Westfall, P.H., Tobias, R.D., Rom, D., Wolfinger, R.D., and Hochberg, Y. (1999), Multiple Comparisons and Multiple Tests Using the SAS System, Cary, NC: SAS Institute Inc.
   Google Scholar
• Williams, D.A. (1971), “Test for Differences Between Treatment Means When Several Dose Levels Are Compared With a Zero Dose Control,” Biometrics, 27, 103–117.
   PubMed Web of Science ®Google Scholar
• Yanagawa, T., and Kikuchi, Y. (2001), “Statistical Issues on the Determination of the No-Observed-Adverse-Effect Levels in Toxicology,” Environmetrics, 12, 319–325. . DOI: 10.1002/env.467.
   Google Scholar