Biomarkers In Drug Discovery And Development

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Biomarkers in Drug Development

Author : Michael R. Bleavins
Publisher : John Wiley & Sons
ISBN 13 : 1118210425
Total Pages : 559 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Biomarkers in Drug Development by : Michael R. Bleavins

Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biomarkers in Drug Discovery and Development

Author : Ramin Rahbari
Publisher : John Wiley & Sons
ISBN 13 : 1119187524
Total Pages : 624 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Biomarkers in Drug Discovery and Development by : Ramin Rahbari

Download or read book Biomarkers in Drug Discovery and Development written by Ramin Rahbari and published by John Wiley & Sons. This book was released on 2020-02-28 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring Includes case studies of biomarkers that have helped and hindered decision making Reviews of the first edition: "If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)

Accelerating the Development of Biomarkers for Drug Safety

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309142318
Total Pages : 101 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Accelerating the Development of Biomarkers for Drug Safety by : Institute of Medicine

Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2009-07-20 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Drug Discovery Toxicology

Author : Yvonne Will
Publisher : John Wiley & Sons
ISBN 13 : 1119053390
Total Pages : 584 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Discovery Toxicology by : Yvonne Will

Download or read book Drug Discovery Toxicology written by Yvonne Will and published by John Wiley & Sons. This book was released on 2016-03-22 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Predictive Approaches in Drug Discovery and Development

Author : J. Andrew Williams
Publisher : John Wiley & Sons
ISBN 13 : 1118230264
Total Pages : 420 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Predictive Approaches in Drug Discovery and Development by : J. Andrew Williams

Download or read book Predictive Approaches in Drug Discovery and Development written by J. Andrew Williams and published by John Wiley & Sons. This book was released on 2012-02-14 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

Biomarkers

Author : Vishal S. Vaidya
Publisher : John Wiley & Sons
ISBN 13 : 9780470918555
Total Pages : 632 pages
Book Rating : 4.9/5 (185 download)

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Book Synopsis Biomarkers by : Vishal S. Vaidya

Download or read book Biomarkers written by Vishal S. Vaidya and published by John Wiley & Sons. This book was released on 2010-10-28 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an introduction to the field of biomarkers, how they have been and can be used, and how different approaches can be used to identify, characterize, and monitor biomarkers. The book has chapters on topics including HIV, Cancer, Parkinson’s, vascular injury, environmental exposure. A following section discusses the technologies (diagnostics and assays) to detect biomarkers and authors have emphasized the preclinical and clinical manifestation of the injury/disease process.

Genomics in Drug Discovery and Development

Author : Dimitri Semizarov
Publisher : John Wiley & Sons
ISBN 13 : 0470409762
Total Pages : 496 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Genomics in Drug Discovery and Development by : Dimitri Semizarov

Download or read book Genomics in Drug Discovery and Development written by Dimitri Semizarov and published by John Wiley & Sons. This book was released on 2008-11-03 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.

Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development

Author : Steven J. Potts
Publisher : Humana
ISBN 13 : 9781493954209
Total Pages : 0 pages
Book Rating : 4.9/5 (542 download)

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Book Synopsis Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development by : Steven J. Potts

Download or read book Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development written by Steven J. Potts and published by Humana. This book was released on 2016-10-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Predictive Biomarkers in Oncology

Author : Sunil Badve
Publisher : Springer
ISBN 13 : 3319952285
Total Pages : 642 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Predictive Biomarkers in Oncology by : Sunil Badve

Download or read book Predictive Biomarkers in Oncology written by Sunil Badve and published by Springer. This book was released on 2018-12-06 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: “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.

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Author : H.Gerhard Vogel
Publisher : Springer Science & Business Media
ISBN 13 : 3540898905
Total Pages : 576 pages
Book Rating : 4.5/5 (48 download)

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Book Synopsis Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel

Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Comprehensive Biomarker Discovery and Validation for Clinical Application

Author : Péter Horvatovich
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734224
Total Pages : 385 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Comprehensive Biomarker Discovery and Validation for Clinical Application by : Péter Horvatovich

Download or read book Comprehensive Biomarker Discovery and Validation for Clinical Application written by Péter Horvatovich and published by Royal Society of Chemistry. This book was released on 2013 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers proteomics biomarker discovery and validation procedures from the clinical perspective.

Biomarkers for Alzheimer’s Disease Drug Development

Author : Robert Perneczky
Publisher : Humana Press
ISBN 13 : 9781493977031
Total Pages : 372 pages
Book Rating : 4.9/5 (77 download)

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Book Synopsis Biomarkers for Alzheimer’s Disease Drug Development by : Robert Perneczky

Download or read book Biomarkers for Alzheimer’s Disease Drug Development written by Robert Perneczky and published by Humana Press. This book was released on 2018-03-07 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume aims to build a new generation of experts with a broader understanding of key topics in the Alzheimer’s disease field. Chapters guide readers through innovative approaches to the discovery of novel biomarkers in cerebrospinal fluid, innovation in blood-based biomarkers, a comprehensive overview of magnetic resonance imaging and molecular imaging approaches and their value for developing drugs for Alzheimer’s disease, cutting-edge developments in neuropathology and their relevance for Alzheimer’s disease trials, novel genomic strategies for biomarker development, and related topics including neuropsychological testing and advanced analytical methods.Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Biomarkers for Alzheimer's Disease Drug Development aims to ensure successful results in the further study of this vital field.

Handbook of Biomarkers and Precision Medicine

Author : Claudio Carini
Publisher : CRC Press
ISBN 13 : 0429574622
Total Pages : 1025 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Handbook of Biomarkers and Precision Medicine by : Claudio Carini

Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 1025 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

Author : Abdel Halim
Publisher : Academic Press
ISBN 13 : 0128161221
Total Pages : 294 pages
Book Rating : 4.1/5 (281 download)

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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 and published by Academic Press. This book was released on 2019-06-08 with total page 294 pages. 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

Neuroscience Biomarkers and Biosignatures

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309178282
Total Pages : 128 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Neuroscience Biomarkers and Biosignatures by : Institute of Medicine

Download or read book Neuroscience Biomarkers and Biosignatures written by Institute of Medicine and published by National Academies Press. This book was released on 2008-01-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.

Statistical Methods in Biomarker and Early Clinical Development

Author : Liang Fang
Publisher : Springer Nature
ISBN 13 : 3030315037
Total Pages : 354 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Statistical Methods in Biomarker and Early Clinical Development by : Liang Fang

Download or read book Statistical Methods in Biomarker and Early Clinical Development written by Liang Fang and published by Springer Nature. This book was released on 2019-12-26 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.

Biomarker Methods in Drug Discovery and Development

Author : Feng Wang
Publisher : Springer Science & Business Media
ISBN 13 : 1934115231
Total Pages : 407 pages
Book Rating : 4.9/5 (341 download)

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Book Synopsis Biomarker Methods in Drug Discovery and Development by : Feng Wang

Download or read book Biomarker Methods in Drug Discovery and Development written by Feng Wang and published by Springer Science & Business Media. This book was released on 2008-03-11 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this book, expert researchers provide a tool box for those who have a general interest in biomarker research and for those currently specializing in certain technologies but desiring an understanding of other available methodologies. Its chapters include validated, mature methods as well as new, incredibly promising protocols. This book is the perfect biomarker technical guideline and reference to stimulate more exciting biomarker research and technology development.