References
- Bornkamp, B. (2015), “Viewpoint: Model Selection Uncertainty, Pre-Specification and Model Averaging,” Pharmaceutical Statistics, 14, 79–81. DOI: https://doi.org/10.1002/pst.1671.
- Bornkamp, B., Bretz, F., Dmitrienko, A., Enas, G., Gaydos, B., Hsu, C. H., Konig, F., Krams, M., Liu, Q., Neuenschwander, B., Parke, T., Pinheiro, J., Roy, A., Sax, R., and Shen, F. (2007), “Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials,” Journal of Biopharmaceutical Statistics, 17, 965–995. DOI: https://doi.org/10.1080/10543400701643848.
- Bretz, F., Dette, H., and Pinheiro, J. (2010), “Practical Considerations for Optimal Designs in Clinical Dose Finding Studies,” Statistics in Medicine, 29, 731–742. DOI: https://doi.org/10.1002/sim.3802.
- Bretz, F., Mollenhoff, K., Dette, H., Liu, W., and Trampisch, M. (2018), “Assessing the Similarity of Dose Response and Target Doses in Two Non-Overlapping Subgroups,” Statistics in Medicine, 37, 722–738. DOI: https://doi.org/10.1002/sim.7546.
- Bretz, F., Pinheiro, J., and Branson, M. (2005), “Combining Multiple Comparisons and Modeling Techniques in Dose-Response Studies,” Biometrics, 61, 738–748. DOI: https://doi.org/10.1111/j.1541-0420.2005.00344.x.
- Chen, J., Quan, H., Binkowitz, B., Ouyang, S. P., Tanaka, Y., Li, G., Menjoge, S., and Ibia, E. (2010), “Assessing Consistent Treatment Effect in a Multi-Regional Clinical Trial: A Systematic Review,” Pharmaceutical Statistics, 9, 242–253. DOI: https://doi.org/10.1002/pst.438.
- Chuang-Stein, C. (2016), “Simultaneous Global Development,” in Multiregional Clinical Trials for Simultaneous Global New Drug Development, eds. J. Chen and H. Quan, New York: Chapman and Hall/CRC, pp. 3–14.
- Dette, H., Möllenhoff, K., Volgushev, S., and Bretz, F. (2018), “Equivalence of Regression Curves,” Journal of the American Statistical Association, 113, 711–729. DOI: https://doi.org/10.1080/01621459.2017.1281813.
- European Medical Agency (2010), “Guideline on the Investigation of Bioequivalence,” available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
- Gsteiger, S., Bretz, F., and Liu, W. (2011), “Simultaneous Confidence Bands for Nonlinear Regression Models With Application to Population Pharmacokinetic Analyses,” Journal of Biopharmaceutical Statistics, 21, 708–725. DOI: https://doi.org/10.1080/10543406.2011.551332.
- International Conference on Harmonization (ICH) (2017), “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,” ICH E17 Guideline on General Principle on Planning/Designing Multi-Regional Clinical Trials, available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17EWG_Step4_2017_1116.pdf.
- Kawai, N., Chuang-Stein, C., Komiyama, O., and Li, Y. (2008), “An Approach to Rationalize Partitioning Sample Size Into Individual Regions in a Multiregional Trial,” Drug Information Journal, 42, 139–147. DOI: https://doi.org/10.1177/009286150804200206.
- Liao, J., Yu, Z., and Li, Y. (2018), “Sample Size Allocation in Multiregional Equivalence Studies,” Pharmaceutical Statistics, 17, 570–577.
- Liu, W., Bretz, F., Hayter, A. J., and Wynn, H. P. (2009), “Assessing Non-Superiority, Non-Inferiority of Equivalence When Comparing Two Regression Models Over a Restricted Covariate Region,” Biometrics, 65, 1279–1287. DOI: https://doi.org/10.1111/j.1541-0420.2008.01192.x.
- Mao, X., and Li, M. (2016), “Implementation of Multiregional Clinical Trial Design,” in Multiregional Clinical Trials for Simultaneous Global New Drug Development, eds. J. Chen and H. Quan, New York: Chapman and Hall/CRC, pp. 131–148
- Ministry of Health, Labour and Welfare of Japan (MHLW) (2007), “Basic Principles on Global Clinical Trials,” available at http://www.pmda.go.jp/files/000153265.pdf.
- Pinheiro, J., and Bornkamp, B. (2017), “Designing Phase II Dose-Finding Studies: Sample Size, Doses, and Dose Allocation Weights,” in Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials, eds. J. O’Quigley, A. Iasonos, and B. Bornkamp, New York: Chapman and Hall/CRC, pp. 229–246.
- Pinheiro, J., Bornkamp, B., and Bretz, F. (2006), “Design and Analysis of Dose-Finding Studies Combining Multiple Comparisons and Modeling Procedures,” Journal of Biopharmaceutical Statistics, 16, 639–656. DOI: https://doi.org/10.1080/10543400600860428.
- Pinheiro, J., Bornkamp, B., Glimm, E., and Bretz, F. (2014), “Model-Based Dose Finding Under Model Uncertainty Using General Parametric Models,” Statistics in Medicine, 33, 1646–1661. DOI: https://doi.org/10.1002/sim.6052.
- Quan, H., Li, M., Chen, J., Gallo, P., Binkowitz, B., Ibia, E., Tanaka, Y., Ouyang, S. P., Luo, X., Li, G., Menjoge, S., Talerico, S., and Ikeda, K. (2010), “Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials,” Drug Information Journal, 44, 617–632. DOI: https://doi.org/10.1177/009286151004400509.
- Quan, H., and Mao, X. (2016), “Quantification of Regional Treatment Effects for Multiregional Clinical Trials,” in Multiregional Clinical Trials for Simultaneous Global New Drug Development, eds. J. Chen and H. Quan, New York: Chapman and Hall/CRC, pp. 203–214.
- Quan, H., Mao, X., Chen, J., Shih, W. J., Ouyang, S. P., Zhang, J., Zhao, P. L., and Binkowitz, B. (2014), “Multi-Regional Clinical Trial Design and Consistency Assessment of Treatment Effects,” Statistics in Medicine, 33, 2191–2205. DOI: https://doi.org/10.1002/sim.6108.
- Quan, H., Zhao, P. L., Zhang, J., Roessner, M., and Aizawa, K. (2010), “Sample Size Considerations for Japanese Patients in a Multi-Regional Trial Based on MHLW Guidance,” Pharmaceutical Statistics, 9, 100–112. DOI: https://doi.org/10.1002/pst.380.
- R Core Team (2018), R: A Language and Environment for Statistical Computing, Vienna, Austria: R Foundation for Statistical Computing, available at https://www.R-project.org/.
- Schorning, K., Bornkamp, B., Bretz, F., and Dette, H. (2016), “Model Selection Versus Model Averaging in Dose Finding Studies,” Statistics in Medicine, 35, 4021–4040. DOI: https://doi.org/10.1002/sim.6991.
- Seber, G. A. F., and Wild, C. J. (2003), Nonlinear Regression, Hoboken, NJ: Wiley-Interscience.
- Teng, Z., Lin, J., and Zhang, B. (2018), “Practical Recommendations for Regional Consistency Evaluation in Multi-Regional Clinical Trials With Different Endpoints,” Statistics in Biopharmaceutical Research, 10, 50–56. DOI: https://doi.org/10.1080/19466315.2017.1379431.
- Tsou, H. H., James Hung, H. M., Chen, Y. M., Huang, W. S., Chang, W. J., and Hsiao, C. F. (2012), “Establishing Consistency Across All Regions in a Multi-Regional Clinical Trial,” Pharmaceutical Statistics, 11, 295–299. DOI: https://doi.org/10.1002/pst.1512.
- Uesaka, H. (2009), “Sample Size Allocation to Regions in a Multiregional Trial,” Journal of Biopharmaceutical Statistics, 19, 580–594. DOI: https://doi.org/10.1080/10543400902963185.
- Verrier, D., Sivapregassam, S., and Solente, A. C. (2014), “Dose-Finding Studies, MCP-Mod, Model Selection, and Model Averaging: Two Applications in the Real World,” Clinical Trials: Journal of the Society for Clinical Trials, 11, 476–484. DOI: https://doi.org/10.1177/1740774514532723.