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The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
  • Author : Federico Goodsaid,William B. Mattes
  • Publisher :Unknown
  • Release Date :2013-07-16
  • Total pages :206
  • ISBN : 9780123944085
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Summary : The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities.

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine
  • Author : Claudio Carini,Mark Fidock,Alain van Gool
  • Publisher :Unknown
  • Release Date :2019-04-16
  • Total pages :631
  • ISBN : 9780429576737
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Summary : "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 of Kidney Disease

Biomarkers of Kidney Disease
  • Author : Charles L. Edelstein
  • Publisher :Unknown
  • Release Date :2016-11-08
  • Total pages :632
  • ISBN : 9780128030356
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Summary : Biomarkers of Kidney Disease, Second Edition, focuses on the basic and clinical research of biomarkers in common kidney diseases, detailing the characteristics of an ideal biomarker. The latest techniques for biomarker detection, including metabolomics and proteomics are covered in the book. This comprehensive book details the latest advances made in the field of biomarker research and development in kidney diseases. The book is an ideal companion for those interested in biomarker research and development, proteomics and metabolomics, kidney diseases, statistical analysis, transplantation, and preeclampsia. New chapters include biomarkers of cardiovascular disease in patients with CKD, biomarkers of Polycystic Kidney Disease, and biomarkers and the role of nanomedicine. Explores both the practical and conceptual steps performed in the discovery of biomarkers in kidney disease Presents a comprehensive account of newer biomarker discover strategies, such as metabolomics and proteomics, all illustrated by clear examples Offers clear translational presentations by the top basic and clinical researchers in each specific renal disease, including AKI, transplantation, cancer, CKD, PKD, diabetic nephropathy, preeclampsia, and glomerular disease

Ensuring National Biosecurity

Ensuring National Biosecurity
  • Author : Carole R Baskin,Alan Zelicoff
  • Publisher :Unknown
  • Release Date :2016-02-03
  • Total pages :270
  • ISBN : 9780128018606
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Summary : Ensuring National Biosecurity: Institutional Biosafety Committees reviews the various responsibilities and associated challenges Institutional Biosafety Committees (IBCs) face and proposes changes that may help improve this system and increase national biosecurity and worker safety. In recent years IBCs in academic and other institutions have been tasked with increasing levels of responsibility, overseeing work with recombinant genetic material and hazardous agents. IBC members often lack the training to effectively ensure that the work performed is truly safe for scientists and the general community, and so increasingly rely upon the expertise of the researchers themselves. With the proposed US dual-use research policies soon to be implemented, this strain may increase. This book provides readers with the necessary information to be able to enhance national biosecurity within the US, EU, Australia, New Zealand, Japan and more. Ensuring National Biosecurity is as an invaluable reference for biosafety professionals or for researchers who need to understand the regulatory landscape that impacts their research. Examines and assesses the current state of Institutional Biosafety Committees (IBCs) Collates contributions from world-renowned experts in fields as diverse as research compliance, law and astrobiology Reflects an international perspective on regulatory biosecurity and biosafety

Biomarkers in Drug Discovery and Development

Biomarkers in Drug Discovery and Development
  • Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
  • Publisher :Unknown
  • Release Date :2020-02-28
  • Total pages :608
  • ISBN : 9781119187516
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Summary : 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)

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
  • Author : Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
  • Publisher :Unknown
  • Release Date :2020-12-23
  • Total pages :318
  • ISBN : 9780429648496
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Summary : The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

Biomarkers in Drug Development

Biomarkers in Drug Development
  • Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
  • Publisher :Unknown
  • Release Date :2011-09-20
  • Total pages :784
  • ISBN : 9781118210420
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Summary : Discover how biomarkers can boost the success rate of drugdevelopment efforts As pharmaceutical companies struggle to improve the success rateand cost-effectiveness of the drug development process, biomarkershave emerged as a valuable tool. This book synthesizes and reviewsthe latest efforts to identify, develop, and integrate biomarkersas a key strategy in translational medicine and the drugdevelopment process. Filled with case studies, the bookdemonstrates how biomarkers can improve drug development timelines,lower costs, facilitate better compound selection, reducelate-stage attrition, and open the door to personalizedmedicine. Biomarkers in Drug Development is divided into eightparts: Part One offers an overview of biomarkers and their role in drugdevelopment. Part Two highlights important technologies to help researchersidentify new biomarkers. Part Three examines the characterization and validation processfor both drugs and diagnostics, and provides practical advice onappropriate statistical methods to ensure that biomarkers fulfilltheir intended purpose. Parts Four through Six examine the application of biomarkers indiscovery, preclinical safety assessment, clinical trials, andtranslational medicine. Part Seven focuses on lessons learned and the practical aspectsof implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including dataintegration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or moreleading experts, including scientists from biotechnology andpharmaceutical firms, academia, and the U.S. Food and DrugAdministration. Their contributions offer pharmaceutical andclinical researchers the most up-to-date understanding of thestrategies used for and applications of biomarkers in drugdevelopment.

Drug Discovery and Development

Drug Discovery and Development
  • Author : Izet Kapetanović
  • Publisher :Unknown
  • Release Date :2011-12-16
  • Total pages :542
  • ISBN : 9789533076157
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Summary : Drug discovery and development process aims to make available medications that are safe and effective in improving the length and quality of life and relieving pain and suffering. However, the process is very complex, time consuming, resource intensive, requiring multi-disciplinary expertise and innovative approaches. There is a growing urgency to identify and develop more effective, efficient, and expedient ways to bring safe and effective products to the market. The drug discovery and development process relies on the utilization of relevant and robust tools, methods, models, and validated biomarkers that are predictive of clinical effects in terms of diagnosis, prevention, therapy, and prognosis. There is a growing emphasis on translational research, a bidirectional bench to the bedside approach, in an effort to improve the process efficiency and the need for further innovations. The authors in the book discuss the current and evolving state of drug discovery and development.

Advancing the Discipline of Regulatory Science for Medical Product Development

Advancing the Discipline of Regulatory Science for Medical Product Development
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher :Unknown
  • Release Date :2016-08-11
  • Total pages :104
  • ISBN : 9780309438841
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Summary : The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

Drug Discovery Toxicology

Drug Discovery Toxicology
  • Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
  • Publisher :Unknown
  • Release Date :2016-03-22
  • Total pages :584
  • ISBN : 9781119053392
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Summary : 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

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Drug Discovery and Evaluation: Methods in Clinical Pharmacology
  • Author : H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
  • Publisher :Unknown
  • Release Date :2010-12-15
  • Total pages :564
  • ISBN : 9783540898900
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Summary : 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

Comprehensive Biomarker Discovery and Validation for Clinical Application
  • Author : Péter Horvatovich,Rainer Bischoff
  • Publisher :Unknown
  • Release Date :2013-06-17
  • Total pages :320
  • ISBN : 9781849734363
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Summary : This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (FDA and EMEA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well-described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of mass spectrometry imaging combined with chromatography in profiling platforms and the use of laser micro dissection and MALDI imaging to study tissues in their natural environment. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers, and those managing biobanks.

Haschek and Rousseaux's Handbook of Toxicologic Pathology

Haschek and Rousseaux's Handbook of Toxicologic Pathology
  • Author : Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig
  • Publisher :Unknown
  • Release Date :2013-05-01
  • Total pages :3054
  • ISBN : 9780124157651
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Summary : Haschek and Rousseaux's Handbook of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. The 3e has been expanded by a full volume, and covers aspects of safety assessment not discussed in the 2e. Completely revised with many new chapters, it remains the most authoritative reference on toxicologic pathology for scientists and researchers studying and making decisions on drugs, biologics, medical devices and other chemicals, including agrochemicals and environmental contaminants. New topics include safety assessment, the drug life cycle, risk assessment, communication and management, carcinogenicity assessment, pharmacology and pharmacokinetics, biomarkers in toxicologic pathology, quality assurance, peer review, agrochemicals, nanotechnology, food and toxicologic pathology, the environment and toxicologic pathology and more. Provides new chapters and in-depth discussion of timely topics in the area of toxicologic pathology and broadens the scope of the audience to include toxicologists and pathologists working in a variety of settings Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology Features hundreds of full color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

Biomarkers

Biomarkers
  • Author : Vishal S. Vaidya,Joseph V. Bonventre
  • Publisher :Unknown
  • Release Date :2010-10-05
  • Total pages :632
  • ISBN : 9780470452240
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Summary : 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.

Knowledge Networks and Markets in the Life Sciences

Knowledge Networks and Markets in the Life Sciences
  • Author : OECD
  • Publisher :Unknown
  • Release Date :2012-05-18
  • Total pages :128
  • ISBN : 9789264168596
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Summary : This report considers the development of Knowledge Networks and Markets and examines the impact of current initiatives and the possible options for governments, working with the private sector, to improve innovation efficiency and effectiveness.

Innovation, Competition and Collaboration

Innovation, Competition and Collaboration
  • Author : Dana Beldiman
  • Publisher :Unknown
  • Release Date :2015-06-29
  • Total pages :224
  • ISBN : 9781784715779
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Summary : As innovation processes become increasingly collaborative, new relationships among players in the innovation space emerge. These developments demand new legal structures that allow horizontally integrated, open and shared use of intellectual property (

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
  • Author : Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease
  • Publisher :Unknown
  • Release Date :2010-06-25
  • Total pages :334
  • ISBN : 9780309157278
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Summary : 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.

Medical Product Safety Evaluation

Medical Product Safety Evaluation
  • Author : Jie Chen,Joseph Heyse,Tze Leung Lai
  • Publisher :Unknown
  • Release Date :2018-09-03
  • Total pages :354
  • ISBN : 9781351021968
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Summary : Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher :Unknown
  • Release Date :2009-07-20
  • Total pages :100
  • ISBN : 0309142318
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Summary : 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.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2004: Agricultural programs: Food and Drug Administration, Farm Credit Administration, Commodity Futures Trading Commission

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2004: Agricultural programs: Food and Drug Administration, Farm Credit Administration, Commodity Futures Trading Commission
  • Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies,United States
  • Publisher :Unknown
  • Release Date :2006
  • Total pages :7
  • ISBN : MINN:31951D02533404J
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Summary :

Omics Technologies in Cancer Biomarker Discovery

Omics Technologies in Cancer Biomarker Discovery
  • Author : Xuewu Zhang
  • Publisher :Unknown
  • Release Date :2011-03-10
  • Total pages :150
  • ISBN : 9781498714006
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Summary : The early detection of human cancer is still one of the great challenges in the battle against this disease. Single biomarkers are not likely to provide sufficient diagnostic power and multibiomarker assays should be developed in order to reach high diagnostic accuracy for cancer screening at the population level. Omics technologies are emerging ne