Open AccessBeyond exposure‐response: A tutorial on statistical considerations in dose‐ranging studies
Author(s) -
Laird Glen,
Xu Lei,
Liu Meng,
Liu Jin
Publication year - 2021
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12998
Subject(s) - ranging , computer science , context (archaeology) , statistical model , pairwise comparison , complement (music) , statistical analysis , data science , statistics , machine learning , artificial intelligence , mathematics , chemistry , biology , telecommunications , paleontology , biochemistry , complementation , gene , phenotype
Dose‐ranging studies are a crucial part of the phase II drug development process. They complement the understanding gained from exposure‐response analyses. However, the statistical design issues related to dose‐ranging studies are not always keenly understood and a poorly designed study can be costly for later development. In this tutorial, we review five key statistical principles in designing such a study. We also describe some popular statistical approaches, including pairwise comparison, modeling, and Multiple Comparison Procedure modeling in the context of principles.