Abstract
According to ICH-E4, “Elucidation of the dose-response function” is a key stage in drug development. Consequently, designing a dose-response study with the desired characteristics is an important activity in drug development. Inadequate dose-response knowledge has been known to lead to a delay or denial in regulatory approvals of initial drug applications. There have also been cases when the dose initially approved for a marketed product had to be reduced subsequently. In this chapter we focus on using the Emax model to describe a dose-response relationship, but the discussion applies equally to other dose-response models or to a collection of models. We examine in detail the three metrics introduced in Chap. 6 for assessing a dose-response study design.
The dose makes the poison.
Paracelsus
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Chuang-Stein, C., Kirby, S. (2017). Designing Dose-Response Studies with Desired Characteristics. In: Quantitative Decisions in Drug Development. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-46076-5_8
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DOI: https://doi.org/10.1007/978-3-319-46076-5_8
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