Shulph Ink
Phase I Oncology Drug Development
Phase I Oncology Drug Development
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The book provides a comprehensive guide for phase I trial designs, including innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies, precision medicine strategies, rational patient allocation, circulating biomarkers, and specialized statistical approaches. It covers the development of different classes of antitumor agents, hematology-oncology drugs, and lessons learned from hematology-oncology drug development. It is designed for clinicians, translational researchers, drug developers, phase I trial study coordinators, oncology nurses, and advanced practice providers, as well as other health professionals interested in the treatment of cancer.
Format: Paperback / softback
Length: 352 pages
Publication date: 18 September 2021
Publisher: Springer Nature Switzerland AG
This book offers a comprehensive overview of the evolution of oncology drug development over the past decade, serving as a valuable resource for practical guidance in setting up phase I trials. It explores strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond, utilizing innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will gain insights into various aspects of modern phase I trial designs, including the integration of precision medicine strategies and rational patient allocation to novel anticancer therapies. Circulating biomarkers for assessing mechanisms of response and resistance are also discussed, highlighting their impact on patient selection. The book covers the development of different classes of antitumor agents, including chemotherapy, molecularly targeted agents, immunotherapies, and radiotherapy. It also draws lessons from the development of hematology-oncology drugs and applies them to therapies for solid tumors. A dedicated chapter delves into specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is intended to assist clinicians in better understanding phase I clinical trials, while also being valuable to translational researchers, drug developers, phase I trial study coordinators, oncology nurses, and advanced practice providers. Additionally, it serves as a valuable resource for other healthcare professionals involved in the treatment of cancer.
Weight: 557g
Dimension: 235 x 155 (mm)
ISBN-13: 9783030476847
Edition number: 1st ed. 2020
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