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Companion and Complementary Diagnostics

Companion and Complementary Diagnostics PDF Author: Jan Trøst Jørgensen
Publisher: Academic Press
ISBN: 0128135409
Category : Medical
Languages : en
Pages : 509

Book Description
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

Companion and Complementary Diagnostics

Companion and Complementary Diagnostics PDF Author: Jan Trøst Jørgensen
Publisher: Academic Press
ISBN: 0128135409
Category : Medical
Languages : en
Pages : 509

Book Description
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

Companion Diagnostics (CDx) in Precision Medicine

Companion Diagnostics (CDx) in Precision Medicine PDF Author: Il-Jin Kim
Publisher: CRC Press
ISBN: 1000007219
Category : Medical
Languages : en
Pages : 206

Book Description
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.

DSM-5 Guidebook

DSM-5 Guidebook PDF Author: Donald W. Black, M.D.
Publisher: American Psychiatric Pub
ISBN: 1585624659
Category : Medical
Languages : en
Pages : 570

Book Description
As a companion to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®), the DSM-5® Guidebook acts as a guide for busy clinicians on the use of diagnostic criteria and codes, documentation, and compensation. It also serves as an educational text and includes a structured curriculum that facilitates its use in courses.

Precision Medicine and Artificial Intelligence

Precision Medicine and Artificial Intelligence PDF Author: Michael Mahler
Publisher: Academic Press
ISBN: 032385432X
Category : Science
Languages : en
Pages : 302

Book Description
Precision Medicine and Artificial Intelligence: The Perfect Fit for Autoimmunity covers background on artificial intelligence (AI), its link to precision medicine (PM), and examples of AI in healthcare, especially autoimmunity. The book highlights future perspectives and potential directions as AI has gained significant attention during the past decade. Autoimmune diseases are complex and heterogeneous conditions, but exciting new developments and implementation tactics surrounding automated systems have enabled the generation of large datasets, making autoimmunity an ideal target for AI and precision medicine. More and more diagnostic products utilize AI, which is also starting to be supported by regulatory agencies such as the Food and Drug Administration (FDA). Knowledge generation by leveraging large datasets including demographic, environmental, clinical and biomarker data has the potential to not only impact the diagnosis of patients, but also disease prediction, prognosis and treatment options. - Allows the readers to gain an overview on precision medicine for autoimmune diseases leveraging AI solutions - Provides background, milestone and examples of precision medicine - Outlines the paradigm shift towards precision medicine driven by value-based systems - Discusses future applications of precision medicine research using AI - Other aspects covered in the book include regulatory insights, data analytics and visualization, types of biomarkers as well as the role of the patient in precision medicine

Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment

Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment PDF Author: Jeffrey Gibbs
Publisher:
ISBN: 9781935065890
Category :
Languages : en
Pages :

Book Description


The selection and use of essential in vitro diagnostics

The selection and use of essential in vitro diagnostics PDF Author:
Publisher: World Health Organization
ISBN: 9240019103
Category : Medical
Languages : en
Pages : 380

Book Description


Rickettsial Diseases

Rickettsial Diseases PDF Author: Didier Raoult
Publisher: CRC Press
ISBN: 142001997X
Category : Medical
Languages : en
Pages : 400

Book Description
The only available reference to comprehensively discuss the common and unusual types of rickettsiosis in over twenty years, this book will offer the reader a full review on the bacteriology, transmission, and pathophysiology of these conditions. Written from experts in the field from Europe, USA, Africa, and Asia, specialists analyze specific patho

Making Medicines Affordable

Making Medicines Affordable PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235

Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Surface Design: Applications in Bioscience and Nanotechnology

Surface Design: Applications in Bioscience and Nanotechnology PDF Author: Renate Förch
Publisher: John Wiley & Sons
ISBN: 3527407898
Category : Science
Languages : en
Pages : 537

Book Description
This carefully selected balance of tutorial-like review chapters and advanced research covers hot topics in the field of biointerfaces, biosensing, nanoparticles at interfaces, and functionalized quantum dots. It also includes chapters arising from non-published work with topics such as surface design and their applications, as well as new developments in analytical tools for materials science and life science. Based on the very close and complementary collaboration of three distinguished leading research groups, this book highlights recent advances in the field ranging from synthesis and fabrication of organic and polymeric materials, surface and interface science to advanced analytical methods. It thus addresses new concepts in micro- and nanofabrication, bio-nanotechnology, biosensors and the necessary compositional and structural analysis. Particular attention is paid throughout to complex hierarchical interface architectures and possible applications of the chemical and physical methodologies discussed, covering bio-diagnostics, novel biosensors and adhesion science. With its unique combination of expertise from chemistry, physics, biology, surface science and engineering, this is a valuable companion for students, practitioners and established experts.

Innovations for Next-Generation Antibody-Drug Conjugates

Innovations for Next-Generation Antibody-Drug Conjugates PDF Author: Marc Damelin
Publisher: Springer
ISBN: 3319781545
Category : Medical
Languages : en
Pages : 358

Book Description
Antibody-drug conjugates (ADCs) stand at the verge of a transformation. Scores of clinical programs have yielded only a few regulatory approvals, but a wave of technological innovation now empowers us to overcome past technical challenges. This volume focuses on the next generation of ADCs and the innovations that will enable them. The book inspires the future by integrating the field’s history with novel strategies and cutting-edge technologies. While the book primarily addresses ADCs for solid tumors, the last chapter explores the emerging interest in using ADCs to treat other diseases. The therapeutic rationale of ADCs is strong: to direct small molecules to the desired site of action (and away from normal tissues) by conjugation to antibodies or other targeting moieties. However, the combination of small and large molecules imposes deep complexity to lead optimization, pharmacokinetics, toxicology, analytics and manufacturing. The field has made significant advances in all of these areas by improving target selection, ADC design, manufacturing methods and clinical strategies. These innovations will inspire and educate scientists who are designing next-generation ADCs with the potential to transform the lives of patients.