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Updated: Sep 26, 2025

Irradiator Commissioning and Dosimetry for Assessment of LQ α and β Parameters, Radiation Dosing Schema, and in vivo Dose Deposition
Published on: March 11, 2021
[Introduction of Oncology Dose-Finding Trial Designs]
1Data Science, Astellas Pharma Global Development, Inc.
Abstract:
The primary objective of oncology dose-finding trials is to estimate the maximum tolerated dose(MTD)and determine the optimal dose(OD)for subsequent clinical trials by evaluating pharmacokinetics and pharmacodynamics of new drugs, treatment effects, and predictive markers. Oncology dose-finding trial designs can be categorized into 3 types based on their statistical bases and implementation approaches: algorithm-based, model-based, and model-assisted designs. In this paper, we introduce the characteristics of various oncology dose-finding trial designs according to the categories. First, oncology dose-finding trial designs solely based on toxicity for MTD determination are discussed, followed by oncology dose-finding trial designs based on efficacy and toxicity for identifying OD. Sequential enrollment, combination therapy, toxicity grade, and historical data are also briefly introduced.
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