Tutorial on Conditional Simulations With a Tumor Size‐Overall Survival Model to Support Oncology Drug Development

Tutorial on Conditional Simulations With a Tumor Size‐Overall Survival Model to Support Oncology Drug Development

ABSTRACT The gold standard for regulatory approval in oncology is overall survival (OS). Because OS data are initially limited, early drug development decisions are often based on early efficacy endpoints, such as objective response rate and progression‐free survival. Tumor size (TS)‐OS models provi...

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Bibliographic Details
Main Authors: Sebastiaan C. Goulooze, Morris Muliaditan, Richard C. Franzese, Alejandro Mantero, Sandra A. G. Visser, Murad Melhem, Teun M. Post, Chetan Rathi, Herbert Struemper
Format: Article
Language:English
Published: Wiley 2025-04-01
Series:CPT: Pharmacometrics & Systems Pharmacology
Subjects:
methodology
model‐based drug development
oncology
population pharmacodynamics
simulation
surrogate endpoint
Online Access:https://doi.org/10.1002/psp4.70003
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https://doi.org/10.1002/psp4.70003

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