Surrogate Tissue Analysis

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Surrogate Tissue Analysis

Author : Michael E. Burczynski
Publisher : CRC Press
ISBN 13 : 1420038095
Total Pages : 332 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Surrogate Tissue Analysis by : Michael E. Burczynski

Download or read book Surrogate Tissue Analysis written by Michael E. Burczynski and published by CRC Press. This book was released on 2005-11-10 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite rapidly expanding interest in potential applications of surrogate tissue analysis and intense competition to identify and validate biomarkers in appropriate surrogate tissues, very few peer reviewed publications describing the use of this approach have appeared in the scientific press. One of the first publications on this topic, Surrogate Tissue Analysis: Genomic, Proteomic, and Metabolomic Approaches describes initial applications and considerations for "omic" technologies in the field of surrogate tissue analysis. Highlighting important issues to consider when conducting profiling studies to identify novel biomarkers, the first section covers transcriptional approaches in surrogate tissues. It provides a review of important issues in peripheral blood profiling, summarizes results achieved when evaluations of various blood preparation platforms are used for the purpose of transcriptional profiling, and covers the relatively novel application of transcriptional profiling in neurological and oncological disease settings. The second section focuses on proteomic and protein-based methods for identifying markers in surrogate tissues, highlighting immunoassay and mass-spectrometry approaches for assessment of proteins in serum and other fluids, with a focus on the implications of protein-based biomarkers for detecting and monitoring early stages of cancer. The third section explores metabolomic approaches along with other novel molecular screens that can be applied in surrogate tissues to find biomarkers, and examines in detail the rapid development of metabolomics into a powerful technique for biomarker identification. The authors conclude with coverage of regulatory considerations, economic impact, and pan-omic strategies which will undoubtedly impact surrogate tissue analysis in the future. They explore current concepts in pan-omic approaches during drug development where a compendium of data generated by multiple profiling approaches are assessed and evaluated with its impact on the field of systems biology. The last chapter rounds out the coverage with a brief look ahead towards future analytical issues that will likely arise in the field of surrogate tissue analysis. The book is both an introduction to the various "omic" technologies in this young field and a fundamental reference for scientists interested in identifying biomarkers in surrogate tissues.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157277
Total Pages : 335 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease by : Institute of Medicine

Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Soft Tissue Sarcomas in Adults

Author : M. Bamberg
Publisher : Springer
ISBN 13 : 9783642787706
Total Pages : 176 pages
Book Rating : 4.7/5 (877 download)

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Book Synopsis Soft Tissue Sarcomas in Adults by : M. Bamberg

Download or read book Soft Tissue Sarcomas in Adults written by M. Bamberg and published by Springer. This book was released on 2011-12-13 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sarcomas represent a group of rare tumors which arise from the largest tissue compartment of the body, but account only for about 1 % of all malignancies. Among this group of tumors, soft tissue sarcomas in adults are, in addition to osteosarcomas, the most important. In the diagnostic workup of soft tissue sarcomas modern radiological investigation methods such as CT and MRI techniques are being critically evaluated. While it is widely accepted that the conventional, stained microscopic specimen is still the cornerstone for properly planned treatment stra tegies, immunohistochemistry has come to play an indis pensable role in accurate classification. Reviewing the surgical techniques, the treatment of musculo-skeletal malignancies, especially of soft tissue sarcomas, has changed considerably over the past decades. While amputation used to be the surgical treatment of choice limb-saving procedures have now become an im portant therapeutic modality in treating such lesions, particularly in combination with percutaneous or interstitial radiotherapy. Despite adequate local treatment, many patients with soft tissue sarcomas will ultimately develop metastatic disease, usually in the lungs. For this reason, effective ad juvant systemic treatment should be given simultaneously with or soon after treatment of local disease. The results of several randomized trials evaluating adjuvant chemotherapy have been reported in the meanwhile, indicating im proved, disease-free survival with a trend towards improved overall survival. In disseminated disease, drug combi- VI Preface nations or single agents are used as palliative treatment and might help to improve survival in selected subgroups.

Biomarkers for Traumatic Brain Injury

Author : Svetlana Dambinova
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733899
Total Pages : 247 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Biomarkers for Traumatic Brain Injury by : Svetlana Dambinova

Download or read book Biomarkers for Traumatic Brain Injury written by Svetlana Dambinova and published by Royal Society of Chemistry. This book was released on 2012 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to injuries sustained in sports and in combat, interest in traumatic brain injury (TBI) has never been greater. This book will fulfill a gap in understanding of what is occurring in the brain following injury that can subsequently be detected in biological fluids and imaging.

Oncology Clinical Trials

Author : Susan Halabi, PhD
Publisher : Demos Medical Publishing
ISBN 13 : 9781935281764
Total Pages : 168 pages
Book Rating : 4.2/5 (817 download)

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Book Synopsis Oncology Clinical Trials by : Susan Halabi, PhD

Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

The Evaluation of Surrogate Endpoints

Author : Tomasz Burzykowski
Publisher : Springer Science & Business Media
ISBN 13 : 0387270809
Total Pages : 417 pages
Book Rating : 4.3/5 (872 download)

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Book Synopsis The Evaluation of Surrogate Endpoints by : Tomasz Burzykowski

Download or read book The Evaluation of Surrogate Endpoints written by Tomasz Burzykowski and published by Springer Science & Business Media. This book was released on 2005-11-24 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.

Perspectives on Biomarker and Surrogate Endpoint Evaluation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309187001
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Perspectives on Biomarker and Surrogate Endpoint Evaluation by : Institute of Medicine

Download or read book Perspectives on Biomarker and Surrogate Endpoint Evaluation written by Institute of Medicine and published by National Academies Press. This book was released on 2011-01-12 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.

Clinical Labor

Author : Melinda Cooper
Publisher : Duke University Press
ISBN 13 : 0822377004
Total Pages : 296 pages
Book Rating : 4.8/5 (223 download)

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Book Synopsis Clinical Labor by : Melinda Cooper

Download or read book Clinical Labor written by Melinda Cooper and published by Duke University Press. This book was released on 2014-01-22 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Forms of embodied labor, such as surrogacy and participation in clinical trials, are central to biomedical innovation, but they are rarely considered as labor. Melinda Cooper and Catherine Waldby take on that project, analyzing what they call "clinical labor," and asking what such an analysis might indicate about the organization of the bioeconomy and the broader organization of labor and value today. At the same time, they reflect on the challenges that clinical labor might pose to some of the founding assumptions of classical, Marxist, and post-Fordist theories of labor. Cooper and Waldby examine the rapidly expanding transnational labor markets surrounding assisted reproduction and experimental drug trials. As they discuss, the pharmaceutical industry demands ever greater numbers of trial subjects to meet its innovation imperatives. The assisted reproductive market grows as more and more households look to third-party providers for fertility services and sectors of the biomedical industry seek reproductive tissues rich in stem cells. Cooper and Waldby trace the historical conditions, political economy, and contemporary trajectory of clinical labor. Ultimately, they reveal clinical labor to be emblematic of labor in twenty-first-century neoliberal economies.

Biomarkers in Toxicology

Author : Ramesh C. Gupta
Publisher : Academic Press
ISBN 13 : 0124046495
Total Pages : 1152 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Biomarkers in Toxicology by : Ramesh C. Gupta

Download or read book Biomarkers in Toxicology written by Ramesh C. Gupta and published by Academic Press. This book was released on 2014-01-25 with total page 1152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers in Toxicology is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This book includes both vertebrate and non-vertebrate species models for toxicological testing and development of biomarkers. Divided into several key sections, this reference volume contains chapters devoted to topics in molecular-cellular toxicology, as well as a look at the latest cutting-edge technologies used to detect biomarkers of exposure and effects. Each chapter also contains several references to the current literature and important resources for further reading. Given this comprehensive treatment, Biomarkers in Toxicology is an essential reference for all those interested in biomarkers across several scientific and biomedical fields. Written by international experts who have evaluated the expansive literature to provide you with one resource covering all aspects of toxicology biomarkers Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure and effect of chemicals of different classes Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation and much more

Monitoring Human Tissues for Toxic Substances

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309044375
Total Pages : 224 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Monitoring Human Tissues for Toxic Substances by : National Research Council

Download or read book Monitoring Human Tissues for Toxic Substances written by National Research Council and published by National Academies Press. This book was released on 1991-02-01 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Human Monitoring Program (NHMP) identifies concentrations of specific chemicals in human tissues, including toxicologic testing and risk assessment determinations. This volume evaluates the current activities of the NHMP; identifies important scientific, technical, and programmatic issues; and makes recommendations regarding the design of the program and use of its products.

QA/QC Guidance for Sampling and Analysis of Sediments, Water, and Tissues for Dredged Material Evaluations

Author :
Publisher :
ISBN 13 :
Total Pages : 334 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis QA/QC Guidance for Sampling and Analysis of Sediments, Water, and Tissues for Dredged Material Evaluations by :

Download or read book QA/QC Guidance for Sampling and Analysis of Sediments, Water, and Tissues for Dredged Material Evaluations written by and published by . This book was released on 1995 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Engineering Design via Surrogate Modelling

Author : Alexander Forrester
Publisher : John Wiley & Sons
ISBN 13 : 0470770791
Total Pages : 228 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Engineering Design via Surrogate Modelling by : Alexander Forrester

Download or read book Engineering Design via Surrogate Modelling written by Alexander Forrester and published by John Wiley & Sons. This book was released on 2008-09-15 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Surrogate models expedite the search for promising designs by standing in for expensive design evaluations or simulations. They provide a global model of some metric of a design (such as weight, aerodynamic drag, cost, etc.), which can then be optimized efficiently. Engineering Design via Surrogate Modelling is a self-contained guide to surrogate models and their use in engineering design. The fundamentals of building, selecting, validating, searching and refining a surrogate are presented in a manner accessible to novices in the field. Figures are used liberally to explain the key concepts and clearly show the differences between the various techniques, as well as to emphasize the intuitive nature of the conceptual and mathematical reasoning behind them. More advanced and recent concepts are each presented in stand-alone chapters, allowing the reader to concentrate on material pertinent to their current design problem, and concepts are clearly demonstrated using simple design problems. This collection of advanced concepts (visualization, constraint handling, coping with noisy data, gradient-enhanced modelling, multi-fidelity analysis and multiple objectives) represents an invaluable reference manual for engineers and researchers active in the area. Engineering Design via Surrogate Modelling is complemented by a suite of Matlab codes, allowing the reader to apply all the techniques presented to their own design problems. By applying statistical modelling to engineering design, this book bridges the wide gap between the engineering and statistics communities. It will appeal to postgraduates and researchers across the academic engineering design community as well as practising design engineers. Provides an inclusive and practical guide to using surrogates in engineering design. Presents the fundamentals of building, selecting, validating, searching and refining a surrogate model. Guides the reader through the practical implementation of a surrogate-based design process using a set of case studies from real engineering design challenges. Accompanied by a companion website featuring Matlab software at http://www.wiley.com/go/forrester

Novel Designs of Early Phase Trials for Cancer Therapeutics

Author : Shivaani Kummar
Publisher : Academic Press
ISBN 13 : 0128125705
Total Pages : 234 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Novel Designs of Early Phase Trials for Cancer Therapeutics by : Shivaani Kummar

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar and published by Academic Press. This book was released on 2018-05-22 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Exploring Novel Clinical Trial Designs for Gene-Based Therapies

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309672988
Total Pages : 127 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Exploring Novel Clinical Trial Designs for Gene-Based Therapies by : National Academies of Sciences, Engineering, and Medicine

Download or read book Exploring Novel Clinical Trial Designs for Gene-Based Therapies written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-08-27 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

Handbook of LC-MS Bioanalysis

Author : Wenkui Li
Publisher : John Wiley & Sons
ISBN 13 : 1118159241
Total Pages : 709 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis Handbook of LC-MS Bioanalysis by : Wenkui Li

Download or read book Handbook of LC-MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-10-21 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.

Paediatric Biomechanics and Motor Control

Author : Mark De Ste Croix
Publisher : Taylor & Francis
ISBN 13 : 1136967869
Total Pages : 329 pages
Book Rating : 4.1/5 (369 download)

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Book Synopsis Paediatric Biomechanics and Motor Control by : Mark De Ste Croix

Download or read book Paediatric Biomechanics and Motor Control written by Mark De Ste Croix and published by Taylor & Francis. This book was released on 2013-03-01 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Paediatric Biomechanics and Motor Control brings together the very latest developmental research using biomechanical measurement and analysis techniques and is the first book to focus on biomechanical aspects of child development. The book is divided into four main sections – the biological changes in children; developmental changes in muscular force production; developmental changes in the biomechanics of postural control and fundamental motor skills and finally the applications of research into paediatric biomechanics and motor control in selected clinical populations. Written by a team of leading experts in paediatric exercise science, biomechanics and motor control from the UK, the US, Australia and Europe, the book is designed to highlight the key implications of this work for scientists, educators and clinicians. Each chapter is preceded by a short overview of the relevant theoretical concepts and concludes with a summary of the practical and clinical applications in relation to the existing literature on the topic. This book is important reading for any sport or exercise scientist, health scientist, physical therapist, sports coach or clinician with an interest in child development or health.

DNA Microarrays

Author : Mark Schena
Publisher : Scion Publishing Ltd
ISBN 13 : 1907904395
Total Pages : 289 pages
Book Rating : 4.9/5 (79 download)

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Book Synopsis DNA Microarrays by : Mark Schena

Download or read book DNA Microarrays written by Mark Schena and published by Scion Publishing Ltd. This book was released on 2007-10-01 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: DNA Microarrays: Methods Express covers the very latest in DNA microarray technology, with a clear focus on how these techniques can be used in the lab to gain the very best results. The authors are from some of the leading laboratories in the field and write with real authority on the latest methodology. Every chapter provides detailed step-by-step protocols with valuable hints and tips for success, as well as giving typical experimental results and selected literature citations. This book is a 'must have' manual for researchers in all fields of biology, medicine and agriculture.