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Dose Finding and Beyond in Biopharmaceutical Development

This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development. Finding the right dose(s) is one of the most important objectives in new drug development. In Phase...

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Dades bibliogràfiques
Autor corporatiu: SpringerLink (Online service)
Altres autors: Ye, Jingjing (Editor), Chen, Ding-Geng (Editor), Zhou, Wen (Editor), Deng, Qiqi (Editor), Cappelleri, Joseph C. (Editor)
Format: Electrònic eBook
Idioma:anglès
Publicat: Cham : Springer Nature Switzerland : Imprint: Springer, 2025.
Edició:1st ed. 2025.
Col·lecció:ICSA Book Series in Statistics,
Matèries:
Biometry.
Experimental design.
Data mining.
Biostatistics.
Design of Experiments.
Data Mining and Knowledge Discovery.
Accés en línia:https://doi.org/10.1007/978-3-031-67110-4
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Taula de continguts:
  • 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.

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