Abstract
As mentioned in Chapter 1, one important step in early clinical development of a new drug is to draft a clinical development plan (CDP). Various clinical studies are designed and carried out according to this plan, and the CDP is updated over time based on newly available information. Estimation of dose–response relationship should be one of the very important components in CDP.
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References
Ellenberg, S.S., and Temple, R. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 2). Annals of Internal Medicine 133(6):464–470.
Chow, S. 2003. Encyclopedia of Biopharmaceutical Statistics. 2nd ed. New York: Marcel Dekker.
Hamlett, A., Ting, N., Hanumara, C., and Finman, J.S. 2002. Dose spacing in early dose response clinical trial designs. Drug Information Journal 36(4):855–864.
Hsu, J.C. 1996. Multiple comparisons—Theory and methods. New York: Chapman-Hall.
ICH E10. 2001. Choice of control group and related issues in clinical trials. Harmonized Tripartite Guideline. http://www.fda.gov/cder/guidance/index.htm
Pukelsheim, F. 1993. Optimal Design of Experiments. New York: Wiley.
Temple, R., and Ellenberg, S.S. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 1). Annals of Internal Medicine 133(6):455–463.
Wong, W.K., and Lachenbruch, P.A. 1996. Tutorial in biostatistics: Designing studies for dose response. Statistics in Medicine 15:343–359.
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Ting, N. (2006). General Considerations in Dose–Response Study Designs. In: Ting, N. (eds) Dose Finding in Drug Development. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/0-387-33706-7_7
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DOI: https://doi.org/10.1007/0-387-33706-7_7
Publisher Name: Springer, New York, NY
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