Abstract
There is a growing recognition of the importance of well-designed dose-finding studies in the overall development process. This chapter is an overview of designs for studies that are meant to identifying one or more doses of an agent to be tested in subsequent stages of the drug development process. The chapter also provides a summary of dose-finding designs that have been developed to meet the challenges of contemporary dose-finding trials, including the use of combinations of agents, more complex outcome measures, and heterogeneous groups of participants.
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Conaway, M.R., Petroni, G.R. (2021). Dose-Finding and Dose-Ranging Studies. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_77-1
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