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Anotace knihy

This book covers topics in 3 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses, and 3) Patient-Centric Drug Development. 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 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 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. All chapter contributors share their data and

computing program to foster transparency and usefulness of their developed methods in drug development.

Parametry knihy

Zařazení knihy Knihy v angličtině Mathematics & science Mathematics Probability & statistics

• Plný název: Dose Finding and Beyond in Biopharmaceutical Development
• Autor: Jingjing Ye, Ding-Geng Chen, Wen Zhou, Qiqi Deng, Joseph C. Cappelleri
• Jazyk: Angličtina
• Vazba: Pevná
• Počet stran: 450
• EAN: 9783031671098
• ID: 46193460
• Nakladatelství: Springer, Berlin
• Rozměry: 235 × 155 mm
• Datum vydání: 02. December 2024

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