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Companion Diagnostics (CDx) in Precision Medicine

2019-03-06 Computers
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Release : 2019-03-06
Genre : Computers
Kind : eBook
Book Rating : 219/5 ( reviews)

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Book Synopsis Companion Diagnostics (CDx) in Precision Medicine by : Il-Jin Kim

Download or read book Companion Diagnostics (CDx) in Precision Medicine written by Il-Jin Kim. This book was released on 2019-03-06. Available in PDF, EPUB and Kindle. Book excerpt: There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.

Companion Diagnostics (CDx) in Precision Medicine

2019 COMPUTERS
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Author :
Release : 2019
Genre : COMPUTERS
Kind : eBook
Book Rating : 382/5 ( reviews)

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Book Synopsis Companion Diagnostics (CDx) in Precision Medicine by : Il-Jin Kim

Download or read book Companion Diagnostics (CDx) in Precision Medicine written by Il-Jin Kim. This book was released on 2019. Available in PDF, EPUB and Kindle. Book excerpt: There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.

Companion and Complementary Diagnostics

2019-05-08 Medical
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Release : 2019-05-08
Genre : Medical
Kind : eBook
Book Rating : 409/5 ( reviews)

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Book Synopsis Companion and Complementary Diagnostics by : Jan Trøst Jørgensen

Download or read book Companion and Complementary Diagnostics written by Jan Trøst Jørgensen. This book was released on 2019-05-08. Available in PDF, EPUB and Kindle. Book excerpt: Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. Covers all aspects, from biomarker discovery, to development and regulatory approval Explains the "how to" aspects of companion diagnostics Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

2019-06-08 Medical
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Release : 2019-06-08
Genre : Medical
Kind : eBook
Book Rating : 221/5 ( reviews)

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Book Synopsis Biomarkers, Diagnostics and Precision Medicine in the Drug Industry by : Abdel Halim

Download or read book Biomarkers, Diagnostics and Precision Medicine in the Drug Industry written by Abdel Halim. This book was released on 2019-06-08. Available in PDF, EPUB and Kindle. Book excerpt: The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations

Precision Medicine and Companion Diagnostic Devices

2018-08
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Release : 2018-08
Genre :
Kind : eBook
Book Rating : 634/5 ( reviews)

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Book Synopsis Precision Medicine and Companion Diagnostic Devices by : Meijuan Li

Download or read book Precision Medicine and Companion Diagnostic Devices written by Meijuan Li. This book was released on 2018-08. Available in PDF, EPUB and Kindle. Book excerpt: A key component of personalized medicine is companion diagnostics that measure biomarkers e.g. protein expression, gene amplification or specific mutations. This will be the first book that covers (1) companion diagnostic device measurement performance, (2) companion diagnostic device clinical performance, (3) companion diagnostic device bridging study, (4) follow-on companion diagnostic device, and (5) the impact of companion diagnostic device measurement performance on clinical validation of personalized medicine.

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