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Full Description
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 I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase Ⅱ clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase Ⅲ confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs.
The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development.
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.
