Pharmaceutical Medicine and Translational Clinical Research Book

Pharmaceutical Medicine and Translational Clinical Research


  • Author : Divya Vohora
  • Publisher : Academic Press
  • Release Date : 2017-10-01
  • Genre: Uncategoriezed
  • Pages : 400
  • ISBN 10 : 0128021039

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Pharmaceutical Medicine and Translational Clinical Research Excerpt :

Pharmaceutical Medicine and Translational Clinical Research is written in a clear and straightforward manner to enable rapid review and assimilation of complex information. It contains reader-friendly features such as learning objectives, multiple choice questions, applied case studies, key takeaway points and more. This book covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines. It also focuses on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics, business administration, medical marketing and the social impact of healthcare on patients and public health are also featured in this book. 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, drug regulatory authorities and contract research organizations. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including orphan drugs, biosimilars, biobetters, super generics, nutraceuticals, pharmaceutical product liability, pharmacovigilance and more Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery, development, evaluation, registration, monitoring and marketing Accompanied by a website featuring updated content between editions such as amendments to regulatory guidelines, statistics and references, as well as an image bank

Pharmaceutical Medicine and Translational Clinical Research Book

Pharmaceutical Medicine and Translational Clinical Research


  • Author : Divya Vohora
  • Publisher : Academic Press
  • Release Date : 2017-11-14
  • Genre: Medical
  • Pages : 526
  • ISBN 10 : 9780128020982

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Pharmaceutical Medicine and Translational Clinical Research Excerpt :

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

Principles of Translational Science in Medicine Book

Principles of Translational Science in Medicine


  • Author : Martin Wehling
  • Publisher : Academic Press
  • Release Date : 2021-07-15
  • Genre: Science
  • Pages : 494
  • ISBN 10 : 9780323999625

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Principles of Translational Science in Medicine Excerpt :

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields. Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization

Translational Medicine and Drug Discovery Book

Translational Medicine and Drug Discovery


  • Author : Bruce H. Littman
  • Publisher : Cambridge University Press
  • Release Date : 2011-01-31
  • Genre: Medical
  • Pages : null
  • ISBN 10 : 9781139498722

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Translational Medicine and Drug Discovery Excerpt :

This book, edited by two innovative leaders in the field, focuses on the new discipline of translational medicine as it pertains to drug development within the pharmaceutical and biotechnology industry. Translational medicine seeks to translate biological and molecular knowledge of disease and how drugs work into innovative development strategies that reduce the cost and increase the speed of delivering new medicines for patients. This book outlines general strategies, biomarker development, imaging tools, translational human models and examples of their application to real drug development. The latest thinking is presented by researchers from many of the world's leading drug development companies, including Pfizer, Merck, Eli Lilly, Abbott and Novartis, as well as academic institutions and public-private partnerships that support translational research. This book is essential for anyone interested in translational medicine from a variety of backgrounds: university institutes, medical schools, pharmaceutical companies and drug development researchers and decision-makers.

Translational Medicine  Tools And Techniques Book

Translational Medicine Tools And Techniques


  • Author : Aamir Shahzad
  • Publisher : Academic Press
  • Release Date : 2015-11-24
  • Genre: Medical
  • Pages : 196
  • ISBN 10 : 9780128034941

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Translational Medicine Tools And Techniques Excerpt :

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

Translational Medicine Book

Translational Medicine


  • Author : Dennis Cosmatos
  • Publisher : CRC Press
  • Release Date : 2008-12-17
  • Genre: Mathematics
  • Pages : 224
  • ISBN 10 : 1584888733

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Translational Medicine Excerpt :

Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients. Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research. Documents Alternative Research Approaches for Faster and More Accurate Data Judgment Calls Elaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts. This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.

Translational Medicine Book

Translational Medicine


  • Author : Joy A. Cavagnaro
  • Publisher : CRC Press
  • Release Date : 2021-11-26
  • Genre: Medical
  • Pages : 952
  • ISBN 10 : 9781000471854

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Translational Medicine Excerpt :

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the bio

Animal and Translational Models for CNS Drug Discovery  Neurological Disorders Book
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Animal and Translational Models for CNS Drug Discovery Neurological Disorders


  • Author : Robert A. McArthur
  • Publisher : Academic Press
  • Release Date : 2008-11-18
  • Genre: Medical
  • Pages : 416
  • ISBN 10 : 0080920381

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Animal and Translational Models for CNS Drug Discovery Neurological Disorders Excerpt :

Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer’s disease, Parkinson’s disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasis on what results mean to the overall drug discovery process Exploration of issues in clinical trial design and conductance in each thera

The Third Histamine Receptor Book

The Third Histamine Receptor


  • Author : Divya Vohora
  • Publisher : CRC Press
  • Release Date : 2008-11-14
  • Genre: Medical
  • Pages : 408
  • ISBN 10 : 9781000687361

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The Third Histamine Receptor Excerpt :

Reveals an Emerging Avenue of Potential Treatments for a Host of Challenging Diseases and DisordersThe H3 receptor is known to play a major role in a range of CNS disorders, including those affecting cognitive functions such as ADHD and Alzheimer's disease, as well as sleep disorders, obesity, epilepsy, schizophrenia, depression, and neurodege

The Role of Purchasers and Payers in the Clinical Research Enterprise Book

The Role of Purchasers and Payers in the Clinical Research Enterprise


  • Author : Institute of Medicine
  • Publisher : Unknown
  • Release Date : 2002-06-14
  • Genre: Uncategoriezed
  • Pages : 120
  • ISBN 10 : 030938320X

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The Role of Purchasers and Payers in the Clinical Research Enterprise Excerpt :

In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

Envisioning a Transformed Clinical Trials Enterprise in the United States Book

Envisioning a Transformed Clinical Trials Enterprise in the United States


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2012-10-13
  • Genre: Medical
  • Pages : 248
  • ISBN 10 : 9780309253154

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Envisioning a Transformed Clinical Trials Enterprise in the United States Excerpt :

There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

Clinical and Translational Science Book

Clinical and Translational Science


  • Author : David Robertson
  • Publisher : Academic Press
  • Release Date : 2016-11-25
  • Genre: Science
  • Pages : 808
  • ISBN 10 : 9780128021118

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Clinical and Translational Science Excerpt :

Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

Neurotherapeutics in the Era of Translational Medicine Book

Neurotherapeutics in the Era of Translational Medicine


  • Author : Richard A. Smith
  • Publisher : Academic Press
  • Release Date : 2020-11-28
  • Genre: Medical
  • Pages : 518
  • ISBN 10 : 9780128172742

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Neurotherapeutics in the Era of Translational Medicine Excerpt :

For the first time in history, there is now hope for treating neurological disorders that had previously been considered untreatable. The remarkable confluence of events that has heralded this is the focus of Neurotherapeutics in the Era of Translational Medicine. This anthology, written by many of the prominent scientists and researchers in the field of biotechnology, recounts the breathtaking advances that are revolutionizing treatment for disorders such as amyotrophic lateral sclerosis‎, spinal muscular atrophy, multiple sclerosis, Parkinson’s disease, myasthenia gravis, migraine, and glioblastoma. The "story behind the story" of these translational efforts is told, with authors depicting the ups and downs encountered on the path of their drug discovery and development effort. In parallel with this path, advances in identifying novel biomarkers and disease models are summarized, as are contemporary issues focusing on clinical trial design, bioethics, innovative funding strategies, and collaborations between government and academia in an effort to facilitate breakthrough treatments. The book is written by members of the biotech and pharmaceutical ecosystem for those who belong to it and aspire to become part of it. Comprehensive review on the progress of translational research in neurotherapeutics for neurologic disorders Discusses important issues in clinical trials such as design and ethical issues Written for neuroscientists, neurologists and pharmacologists

Improving and Accelerating Therapeutic Development for Nervous System Disorders Book

Improving and Accelerating Therapeutic Development for Nervous System Disorders


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2014-02-06
  • Genre: Medical
  • Pages : 118
  • ISBN 10 : 9780309292498

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Improving and Accelerating Therapeutic Development for Nervous System Disorders Excerpt :

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Sharing Clinical Trial Data Book

Sharing Clinical Trial Data


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2015-04-20
  • Genre: Medical
  • Pages : 304
  • ISBN 10 : 9780309316323

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Sharing Clinical Trial Data Excerpt :

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.