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Author: Steven J. Potts
Publisher: Humana
ISBN: 9781493954209
Category : Medical
Languages : en
Pages : 0
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Book Description
Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical trials. While many current applications of quantitative histology and molecular pathology in the biopharmaceutical industry are focused on oncology, this volume in addition explores non-oncologic disease areas including nonalcoholic steatohepatitis, arthritis, celiac disease, myeloproliferative disorders, neurology, and wound healing. The authors write from years of experience in diagnostic practice and pharmaceutical drug development, aiming to educate pharmaceutical and academic scientists how to best use tissue to diagnose disease and improve the process of drug development. As part of the Methods in Pharmacology and Toxicology series, this volume is designed to provide wisdom and examples that others can follow and apply as part of drug development. Comprehensive and practical, Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development will inform and enlighten both tissue-focused and non-tissue-focused drug development professionals about better use and interpretation of the multidimensional data contained in a tissue biopsy.
Author: Steven J. Potts
Publisher: Humana
ISBN: 9781493954209
Category : Medical
Languages : en
Pages : 0
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Book Description
Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development gathers diverse experts to present state of the art guidance and application of histopathology in drug development settings ranging from discovery research to human clinical trials. While many current applications of quantitative histology and molecular pathology in the biopharmaceutical industry are focused on oncology, this volume in addition explores non-oncologic disease areas including nonalcoholic steatohepatitis, arthritis, celiac disease, myeloproliferative disorders, neurology, and wound healing. The authors write from years of experience in diagnostic practice and pharmaceutical drug development, aiming to educate pharmaceutical and academic scientists how to best use tissue to diagnose disease and improve the process of drug development. As part of the Methods in Pharmacology and Toxicology series, this volume is designed to provide wisdom and examples that others can follow and apply as part of drug development. Comprehensive and practical, Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development will inform and enlighten both tissue-focused and non-tissue-focused drug development professionals about better use and interpretation of the multidimensional data contained in a tissue biopsy.
Author: William B. Coleman
Publisher: Academic Press
ISBN: 0128229934
Category : Science
Languages : en
Pages : 846
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Book Description
Diagnostic Molecular Pathology: A Guide to Applied Molecular Testing, Second Edition assembles a group of experts to discuss the molecular basis and mechanisms of major human diseases and disease processes and how the molecular features of disease can be harnessed to develop practical molecular tests for disease detection, diagnosis and prognosis. The book explains how molecular tests are utilized in the treatment of patients in personalized medicine, highlights new technologies and approaches of applied molecular pathology, and discusses how this discovery-based research yields new and useful biomarkers and tests. As it is essential to stay up-to-date on new molecular diagnostics in this changing field, this book covers critically important areas in the practice of personalized medicine and reflects our understanding of the pathology, pathogenesis and pathophysiology of human disease. Includes new material on mass spectrometry for infectious diseases, microbiome, homology-directed repair for PARPi, whole genome sequencing for constitutional testing, and much more Provides insights on the value of the molecular test in comparison to traditional methods, which include speed, precision, sensitivity and clinical impacts for the patient Focuses on the menu of molecular diagnostic tests available in modern molecular pathology or clinical laboratories that can be applied to disease detection, diagnosis and classification in the clinical workup of a patient Explains how molecular tests are utilized to guide the treatment of patients in personalized medicine (guided therapies) and for the prognostication of disease
Author: Shiyang Pan
Publisher: Springer Nature
ISBN: 9811610371
Category : Medical
Languages : en
Pages : 889
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Book Description
This book covers the discovery of molecular biomarkers, the development of laboratory testing techniques and their clinical applications, focusing on basic research to clinical practice. It introduces new and crucial knowledge and ethics of clinical molecular diagnosis. This book emphasizes the applications of clinical molecular diagnostic test on health management, especially from different diseased organs. It lets readers to understand and realize precision healthcare.
Author: Michael R. Bleavins
Publisher: John Wiley & Sons
ISBN: 1118210425
Category : Medical
Languages : en
Pages : 559
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Book Description
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Author: Gurcan
Publisher: Wiley-Blackwell
ISBN: 9781119099093
Category :
Languages : en
Pages : 256
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Book Description
Author: Sunil Badve
Publisher: Springer
ISBN: 3319952285
Category : Medical
Languages : en
Pages : 642
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Book Description
“Precision/personalized or stratified medicine” refers to the tailoring of medical treatment or drug administration to the individual characteristics of each patient treatment. It does not literally mean that a pharmaceutical company makes a drug for an individual patient for consumption and treatment but rather means the ability to stratify (or classify) individuals into sub-populations that differ in their responsiveness to a specific drug. A marker that provides information on the likely response to therapy, i.e., either in terms of tumor shrinkage or survival of the patient is termed “predictive biomarker”. Despite their promise in precision medicine and the explosion of knowledge in this area, there is not a single source on this subject that puts all this evidence together in a concise or richly illustrated and easy to understand manner. This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.
Author: Jan Trøst Jørgensen
Publisher: Academic Press
ISBN: 0128135409
Category : Medical
Languages : en
Pages : 508
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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
Author: Cecilia M. Fenoglio-Preiser
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 400
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Book Description
Author: Simone Mocellin
Publisher: Springer Nature
ISBN: 303058710X
Category : Medical
Languages : en
Pages : 718
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Book Description
The “world” of soft tissue sarcomas is a highly complex one, due to the large range of tumor types, each of which is characterized by specific features in terms of its epidemiology, pathology diagnosis, clinical behavior, therapy and biomarker pattern (of both diagnostic and therapeutic value). This book offers a practical, clearly structured reference guide, covering all of these aspects for each soft tissue tumor. Thanks to the consistent and user-friendly format, readers can quickly and easily find the information they need; in addition, up-to-date and authoritative literature information helps them to pursue further research. Overall, this book offers professionals and residents in the fields of oncology, surgery, and pathology an essential guide for study, review, and everyday clinical practice.
Author: William B. Coleman
Publisher: Academic Press
ISBN: 0128027878
Category : Medical
Languages : en
Pages : 802
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Book Description
As the molecular basis of human disease becomes better characterized, and the implications for understanding the molecular basis of disease becomes realized through improved diagnostics and treatment, Molecular Pathology, Second Edition stands out as the most comprehensive textbook where molecular mechanisms represent the focus. It is uniquely concerned with the molecular basis of major human diseases and disease processes, presented in the context of traditional pathology, with implications for translational molecular medicine. The Second Edition of Molecular Pathology has been thoroughly updated to reflect seven years of exponential changes in the fields of genetics, molecular, and cell biology which molecular pathology translates in the practice of molecular medicine. The textbook is intended to serve as a multi-use textbook that would be appropriate as a classroom teaching tool for biomedical graduate students, medical students, allied health students, and others (such as advanced undergraduates). Further, this textbook will be valuable for pathology residents and other postdoctoral fellows that desire to advance their understanding of molecular mechanisms of disease beyond what they learned in medical/graduate school. In addition, this textbook is useful as a reference book for practicing basic scientists and physician scientists that perform disease-related basic science and translational research, who require a ready information resource on the molecular basis of various human diseases and disease states. Explores the principles and practice of molecular pathology: molecular pathogenesis, molecular mechanisms of disease, and how the molecular pathogenesis of disease parallels the evolution of the disease Explains the practice of “molecular medicine and the translational aspects of molecular pathology Teaches from the perspective of “integrative systems biology Enhanced digital version included with purchase
