Dose Finding and Beyond in Biopharmaceutical Development
Buch in deiner Nähe kaufen
Beschreibung
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.
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.
Provides a natural discourse on the major advances over the last 20 years Emphasizes case studies and best practices in dose-finding/dose-optimization in the evolving drug development paradigm Supplies real data and computer programs for readers to practice the new methods
Autor*in
Jingjing Ye
Themen in »Dose Finding and Beyond in Biopharmaceutical Development«
Dose-finding designs dose response clinical trials clinical research drug development Project Optimus precision medicine patient-centered research patient-reported outcomes