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Title Dose finding and beyond in biopharmaceutical development / Jingjing Ye, Ding-Geng Chen, Wen Zhou, Qiqi Deng, Joseph C. Cappelleri, editors
Published Cham : Springer, [2025]
©2025

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Description 1 online resource (xvii, 254 pages) : illustrations
Series ICSA book series in statistics, 2199-0999
ICSA book series in statistics. 2199-0999
Contents Emerging Topics in Dose-Finding and Beyond -- Understanding FDA Guidance On Dosage Optimization For Oncology Therapies -- FDA Project Optimus: The "Paradigm-Shifting" Initiative for Oncology Drug Development -- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs -- Challenges and Practical Guidance on the Implementation of Novel Oncology Dose Escalation Designs -- Monotonic Dose Response Assumption and Curve-Free Designs for Phase I Dose Finding Trials -- Dose Selection with 2-in-1 Design -- A Rank-Based Approach to Improve the Efficiency of Inferential Seamless Phase 2/3 Clinical Trials with Dose Optimization -- Comparing MCP-MOD and Ordinal Linear Contrast Test in Dose Finding Clinical Trials: A Thorough Examination -- Patient-Reported Tolerability in Drug Development -- Endpoint Development and Validation
Bibliography Includes bibliographical references
Notes Online resource; title from PDF title page (SpringerLink, viewed November 6, 2024)
Subject Drug development.
Drugs -- Dosage.
Biometry.
Biometry
biometrics.
Form Electronic book
Author Ye, Jingjing, editor
Chen, Ding-Geng, editor.
Zhou, Wen, editor
Deng, Qiqi, editor
Cappelleri, Joseph C., editor.
ISBN 9783031671104
3031671104