Abstract
It should be noted that contributions of statistical science to modern medicine are not limited to statistical methods for estimating sample sizes, calculating p-values or confidence intervals.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Dmitrienko, A., Wiens, B., & Westfall, P. (2006). Clinical trials. Journal of Biopharmaceutical Statistics, 16(5), 745–755.
Fricke, J., Varkalis, J., Zwillich, S., Adler, R., Forester, E., Recker, D. P., et al. (2002). Valdecoxib is more efficacious than rofecoxib in relieving pain associated with oral surgery. American Journal of Therapeutics, 9(2), 89–97.
Hamlett, A., Ting, N., Hanumara, C., & Finman, J. S. (2002). Dose spacing in early dose response clinical trial designs. Drug Information Journal, 36(4), 855–864.
ICH E9 Statistical Principles for Clinical Trials. (1998). International conference on harmonization—Harmonized Tripartite Guideline.
Mallinckrodt, C. H., Lane, P. W., Schnell, D., Peng, Y., & Mancuso, J. P. (2008). Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials. Drug Information Journal, 42, 303–319.
Penel, N., & Kramar, A. (2012). What does a modified-Fibonacci dose-escalation actually correspond to? BMC Medical Research Methodology, BMC series, 103. doi:10.1186/1471-2288-12-103
Pinheiro, J. C., Bretz, F., & Branson, M. (2003). Analysis of dose-response studies—Modeling approaches. In Dose finding in drug development (pp. 146–171). New York: Springer.
Quinlan, J. A., & Krams, M. (2006). Implementing adaptive designs: Logistical and operational consideration. Drug Information Journal, 40, 437–444.
Ruberg, S. J. (1995). Dose response studies II. Analysis and interpretation. Journal of Biopharmaceutical Statistics, 5(1), 15–42.
Tamhane, A. C., Hochberg, Y., & Dunnett, C. W. (1996). Multiple test procedures for dose finding. Biometrics, 52, 21–37.
Ting, N. (2003). Introduction and new drug development. In Dose finding in drug development (pp. 1–17). New York: Springer.
Westfall, P. H., & Krishen, A. (2001). Optimally weighted, fixed sequence and gatekeeping multiple testing procedures. Journal of Statistical Planning and Inference, 99, 25–40.
Wong, W. K., & Lachenbruch, P. A. (1996). Tutorial in biostatistics: Designing studies for dose response. Statistics in Medicine, 15, 343–359.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
Copyright information
© 2017 Springer Nature Singapore Pte Ltd.
About this chapter
Cite this chapter
Ting, N., Chen, DG., Ho, S., Cappelleri, J.C. (2017). Confirmation and Exploration. In: Phase II Clinical Development of New Drugs. ICSA Book Series in Statistics. Springer, Singapore. https://doi.org/10.1007/978-981-10-4194-5_3
Download citation
DOI: https://doi.org/10.1007/978-981-10-4194-5_3
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-10-4192-1
Online ISBN: 978-981-10-4194-5
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)