Optimal biological dose selection in dose-finding trials with model-assisted designs based on efficacy and toxicity: a simulation study

Author:

Yamaguchi Yusuke1ORCID,Takeda Kentaro1ORCID,Yoshida Satoshi2,Maruo Kazushi3ORCID

Affiliation:

1. Astellas Pharma Global Development, Inc, Northbrook, Illinois, USA

2. Data Science, Astellas Pharma Inc, Tokyo, Japan

3. Department of Biostatistics, University of Tsukuba, Tsukuba, Japan

Funder

financial support

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference41 articles.

1. Ambler, G., and A. Benner. Mfp: Multivariable fractional polynomials. Last Modified October 13, 2022. Accessed November 10, 2022. https://cran.r-project.org/web/packages/mfp/mfp.pdf.

2. Algorithm AS 206: Isotonic Regression in Two Independent Variables

3. U-Shaped Dose-Responses in Biology, Toxicology, and Public Health

4. Clinical efficacy of the optimal biological dose in early-phase trials of anti-cancer targeted therapies

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