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Titlebook: Dose Finding and Beyond in Biopharmaceutical Development; Jingjing Ye,Ding-Geng Chen,Joseph C. Cappelleri Book 2025 The Editor(s) (if appl

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書目名稱Dose Finding and Beyond in Biopharmaceutical Development
編輯Jingjing Ye,Ding-Geng Chen,Joseph C. Cappelleri
視頻videohttp://file.papertrans.cn/285/284821/284821.mp4
概述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.Supplie
叢書名稱ICSA Book Series in Statistics
圖書封面Titlebook: Dose Finding and Beyond in Biopharmaceutical Development;  Jingjing Ye,Ding-Geng Chen,Joseph C. Cappelleri Book 2025 The Editor(s) (if appl
描述.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 developme
出版日期Book 2025
關(guān)鍵詞Dose-finding designs; dose response clinical trials; clinical research; drug development; Project Optimu
版次1
doihttps://doi.org/10.1007/978-3-031-67110-4
isbn_softcover978-3-031-67112-8
isbn_ebook978-3-031-67110-4Series ISSN 2199-0980 Series E-ISSN 2199-0999
issn_series 2199-0980
copyrightThe Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl
The information of publication is updating

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https://doi.org/10.1007/978-3-642-92507-8luding leukemia 2023, kidney cancer, and melanoma (Siegel, CA Cancer J Clin 73(1):17–48, 2023). The development of targeted therapies, in particular, has dramatically altered the therapeutic landscape and improved outcomes for patients. Despite the seismic changes that have occurred in the field, so
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dbreaking initiative had fundamentally changed the oncology dose-finding paradigm: discouraging outdated conventions since the era of cytotoxic agents (identifying the maximum tolerated dose, MTD), and embracing new practices of identifying the optimal dosage among multiple doses based on totality o
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Bits, Bytes, Words and Numbers,e treatments, oncology trials need to start human research at a lower dose level and then move up and down through some dose levels in a process called dose finding that helps determine a safe dose level. The toxicity of these oncology drugs is always assumed to increase with dose. However, unlike i
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