The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
Author: Federico Goodsaid,William B. Mattes
Publsiher: Academic Press
Total Pages: 206
Release: 2013-07-16
ISBN 10: 0123944082
ISBN 13: 9780123944085
Language: EN, FR, DE, ES & NL

The Path from Biomarker Discovery to Regulatory Qualification Book Review:

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
Publsiher: CRC Press
Total Pages: 631
Release: 2019-04-16
ISBN 10: 0429576730
ISBN 13: 9780429576737
Language: EN, FR, DE, ES & NL

Handbook of Biomarkers and Precision Medicine Book Review:

"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.

Agriculture Rural Development and Related Agencies Appropriations

Agriculture  Rural Development  and Related Agencies Appropriations
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies
Publsiher: Unknown
Total Pages: 329
Release: 2007
ISBN 10:
ISBN 13: PSU:000058932339
Language: EN, FR, DE, ES & NL

Agriculture Rural Development and Related Agencies Appropriations Book Review:

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
Author: Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
Publsiher: CRC Press
Total Pages: 318
Release: 2020-12-23
ISBN 10: 0429648499
ISBN 13: 9780429648496
Language: EN, FR, DE, ES & NL

Current Topics in Nonclinical Drug Development Book Review:

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.

Drug Discovery Toxicology

Drug Discovery Toxicology
Author: Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publsiher: John Wiley & Sons
Total Pages: 584
Release: 2016-03-16
ISBN 10: 1119053323
ISBN 13: 9781119053323
Language: EN, FR, DE, ES & NL

Drug Discovery Toxicology Book Review:

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
Publsiher: Springer Science & Business Media
Total Pages: 564
Release: 2010-12-15
ISBN 10: 3540898905
ISBN 13: 9783540898900
Language: EN, FR, DE, ES & NL

Drug Discovery and Evaluation Methods in Clinical Pharmacology Book Review:

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".

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
Publsiher: National Academies Press
Total Pages: 334
Release: 2010-06-25
ISBN 10: 0309157277
ISBN 13: 9780309157278
Language: EN, FR, DE, ES & NL

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Book Review:

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.

Biomarkers in Drug Development

Biomarkers in Drug Development
Author: Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
Publsiher: John Wiley & Sons
Total Pages: 784
Release: 2011-09-20
ISBN 10: 1118210425
ISBN 13: 9781118210420
Language: EN, FR, DE, ES & NL

Biomarkers in Drug Development Book Review:

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.

American Journal of Respiratory and Critical Care Medicine

American Journal of Respiratory and Critical Care Medicine
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2007
ISBN 10:
ISBN 13: IND:30000121560886
Language: EN, FR, DE, ES & NL

American Journal of Respiratory and Critical Care Medicine Book Review:

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
Publsiher: National Academies Press
Total Pages: 100
Release: 2009-08-20
ISBN 10: 0309131243
ISBN 13: 9780309131247
Language: EN, FR, DE, ES & NL

Accelerating the Development of Biomarkers for Drug Safety Book Review:

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.

Predictive Biomarkers in Oncology

Predictive Biomarkers in Oncology
Author: Sunil Badve,George Louis Kumar
Publsiher: Springer
Total Pages: 642
Release: 2018-12-06
ISBN 10: 3319952285
ISBN 13: 9783319952284
Language: EN, FR, DE, ES & NL

Predictive Biomarkers in Oncology Book Review:

“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.

The Handbook of Biomarkers

The Handbook of Biomarkers
Author: Kewal K. Jain
Publsiher: Springer Science & Business Media
Total Pages: 492
Release: 2010-02-06
ISBN 10: 9781607616856
ISBN 13: 1607616858
Language: EN, FR, DE, ES & NL

The Handbook of Biomarkers Book Review:

Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author: Divya Vohora,Gursharan Singh
Publsiher: Academic Press
Total Pages: 526
Release: 2017-11-14
ISBN 10: 0128020989
ISBN 13: 9780128020982
Language: EN, FR, DE, ES & NL

Pharmaceutical Medicine and Translational Clinical Research Book Review:

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publsiher: National Academies Press
Total Pages: 442
Release: 2011-04-03
ISBN 10: 0309158060
ISBN 13: 9780309158060
Language: EN, FR, DE, ES & NL

Rare Diseases and Orphan Products Book Review:

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

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
Publsiher: Academic Press
Total Pages: 3054
Release: 2013-05-01
ISBN 10: 0124157653
ISBN 13: 9780124157651
Language: EN, FR, DE, ES & NL

Haschek and Rousseaux s Handbook of Toxicologic Pathology Book Review:

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

Global Approach in Safety Testing

Global Approach in Safety Testing
Author: Jan Willem van der Laan,Joseph J DeGeorge
Publsiher: Springer Science & Business Media
Total Pages: 315
Release: 2013-02-11
ISBN 10: 1461459508
ISBN 13: 9781461459507
Language: EN, FR, DE, ES & NL

Global Approach in Safety Testing Book Review:

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

Managing the Drug Discovery Process

Managing the Drug Discovery Process
Author: Walter Moos,Susan Miller,Stephen Munk,Barbara Munk
Publsiher: Woodhead Publishing
Total Pages: 536
Release: 2016-11-08
ISBN 10: 0081006322
ISBN 13: 9780081006320
Language: EN, FR, DE, ES & NL

Managing the Drug Discovery Process Book Review:

Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry. Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable

Translational Medicine Tools And Techniques

Translational Medicine  Tools And Techniques
Author: Aamir Shahzad
Publsiher: Academic Press
Total Pages: 196
Release: 2015-11-24
ISBN 10: 0128034947
ISBN 13: 9780128034941
Language: EN, FR, DE, ES & NL

Translational Medicine Tools And Techniques Book Review:

Translational Medicine: Tools and Techniques provides a standardized path from basic research to the clinic and brings together various policy and practice issues to simplify the broad interdisciplinary field. With discussions from academic and industry leaders at international institutions who have successfully implemented translational medicine techniques and tools in various settings, readers will be guided through implementation strategies relevant to their own needs and institutions. The book also addresses regulatory processes in USA, EU, Japan and China. By providing details on omics sciences techniques, biomarkers, data mining and management approaches, case reports from industry, and tools to assess the value of different technologies and techniques, this book is the first to provide a user-friendly go-to guide for key opinion leaders (KOLs), industry administrators, faculty members, clinicians, researchers, and students interested in translational medicine. Includes detailed and standardized information about the techniques and tools used in translational medicine Provides specific industry case scenarios Explains how to use translational medicine tools and techniques to plan and improve infrastructures and capabilities while reducing cost and optimizing resources

Statistical Methods in Biomarker and Early Clinical Development

Statistical Methods in Biomarker and Early Clinical Development
Author: Liang Fang,Cheng Su
Publsiher: Springer Nature
Total Pages: 348
Release: 2020-02-24
ISBN 10: 3030315037
ISBN 13: 9783030315030
Language: EN, FR, DE, ES & NL

Statistical Methods in Biomarker and Early Clinical Development Book Review:

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.

Oncology

Oncology
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2006
ISBN 10:
ISBN 13: UCLA:L0090580473
Language: EN, FR, DE, ES & NL

Oncology Book Review: