The Path from Biomarker Discovery to Regulatory Qualification

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.

Produk Detail:

  • Author : Federico Goodsaid
  • Publisher : Academic Press
  • Pages : 206 pages
  • ISBN : 0123944082
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKThe Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
  • Author : Federico Goodsaid,William B. Mattes
  • Publisher : Academic Press
  • Release : 16 July 2013
GET THIS BOOKThe Path from Biomarker Discovery to Regulatory Qualification

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—

Drug Discovery Toxicology

Drug Discovery Toxicology
  • Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
  • Publisher : John Wiley & Sons
  • Release : 18 April 2016
GET THIS BOOKDrug Discovery Toxicology

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

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine
  • Author : Claudio Carini,Mark Fidock,Alain van Gool
  • Publisher : CRC Press
  • Release : 16 April 2019
GET THIS BOOKHandbook of Biomarkers and Precision Medicine

"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

Translational Medicine: Tools And Techniques

Translational Medicine: Tools And Techniques
  • Author : Aamir Shahzad
  • Publisher : Academic Press
  • Release : 24 November 2015
GET THIS BOOKTranslational Medicine: Tools And Techniques

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

Ensuring National Biosecurity

Ensuring National Biosecurity
  • Author : Carole R Baskin,Alan Zelicoff
  • Publisher : Academic Press
  • Release : 03 February 2016
GET THIS BOOKEnsuring National Biosecurity

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

Biomarkers of Kidney Disease

Biomarkers of Kidney Disease
  • Author : Charles L. Edelstein
  • Publisher : Academic Press
  • Release : 08 November 2016
GET THIS BOOKBiomarkers of Kidney Disease

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

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
  • Author : Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
  • Publisher : CRC Press
  • Release : 23 December 2020
GET THIS BOOKCurrent Topics in Nonclinical Drug Development

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.

Biomarkers in Drug Discovery and Development

Biomarkers in Drug Discovery and Development
  • Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
  • Publisher : John Wiley & Sons
  • Release : 28 February 2020
GET THIS BOOKBiomarkers in Drug Discovery and Development

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

Encyclopedia of Analytical Science

Encyclopedia of Analytical Science
  • Author : Anonim
  • Publisher : Elsevier
  • Release : 02 April 2019
GET THIS BOOKEncyclopedia of Analytical Science

The third edition of the Encyclopedia of Analytical Science is a definitive collection of articles covering the latest technologies in application areas such as medicine, environmental science, food science and geology. Meticulously organized, clearly written and fully interdisciplinary, the Encyclopedia of Analytical Science provides foundational knowledge across the scope of modern analytical chemistry, linking fundamental topics with the latest methodologies. Articles will cover three broad areas: analytical techniques (e.g., mass spectrometry, liquid chromatography, atomic spectrometry); areas of application (e.

Comprehensive Biomarker Discovery and Validation for Clinical Application

Comprehensive Biomarker Discovery and Validation for Clinical Application
  • Author : Péter Horvatovich,Rainer Bischoff
  • Publisher : Royal Society of Chemistry
  • Release : 17 June 2013
GET THIS BOOKComprehensive Biomarker Discovery and Validation for Clinical Application

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

Biomarkers in Drug Development

Biomarkers in Drug Development
  • Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOKBiomarkers in Drug Development

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

Drug Discovery and Development

Drug Discovery and Development
  • Author : Izet Kapetanović
  • Publisher : BoD – Books on Demand
  • Release : 16 December 2011
GET THIS BOOKDrug Discovery and Development

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

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 : National Academies Press
  • Release : 25 June 2010
GET THIS BOOKEvaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

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

Biomarkers
  • Author : Vishal S. Vaidya,Joseph V. Bonventre
  • Publisher : John Wiley & Sons
  • Release : 05 October 2010
GET THIS BOOKBiomarkers

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.

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 : National Academies Press
  • Release : 11 August 2016
GET THIS BOOKAdvancing the Discipline of Regulatory Science for Medical Product Development

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,