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Author: Martin Wehling
Publisher: Academic Press
ISBN: 0128007214
Category : Science
Languages : en
Pages : 364
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Book Description
Principles of Translational Science in Medicine: From Bench to Bedside, Second 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 numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies Details IPR issues of translation, especially for public-private-partnerships Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions
Author: Martin Wehling
Publisher: Academic Press
ISBN: 0128007214
Category : Science
Languages : en
Pages : 364
Get Book
Book Description
Principles of Translational Science in Medicine: From Bench to Bedside, Second 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 numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies Details IPR issues of translation, especially for public-private-partnerships Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions
Author: David Robertson
Publisher: Academic Press
ISBN: 012802111X
Category : Science
Languages : en
Pages : 812
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Book Description
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
Author: John I. Gallin
Publisher: Elsevier
ISBN: 9780080489568
Category : Medical
Languages : en
Pages : 448
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Book Description
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government
Author: Joy A. Cavagnaro
Publisher: CRC Press
ISBN: 1000471853
Category : Medical
Languages : en
Pages : 952
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Book Description
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 biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Author: Lei Yang
Publisher: Academic Press
ISBN: 012813478X
Category : Technology & Engineering
Languages : en
Pages : 358
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Book Description
Biomaterials in Translational Medicine delivers timely and detailed information on the latest advances in biomaterials and their role and impact in translational medicine. Key topics addressed include the properties and functions of these materials and how they might be applied for clinical diagnosis and treatment. Particular emphasis is placed on basic fundamentals, biomaterial formulations, design principles, fabrication techniques and transitioning bench-to-bed clinical applications. The book is an essential reference resource for researchers, clinicians, materials scientists, engineers and anyone involved in the future development of innovative biomaterials that drive advancement in translational medicine. Systematically introduces the fundamental principles, rationales and methodologies of creating or improving biomaterials in the context of translational medicine Includes the translational or commercialization status of these new biomaterials Provides the reader with enough background knowledge for a fundamental grip of the difficulties and technicalities of using biomaterial translational medicine Directs the reader on how to find other up-to-date sources (i.e. peer reviewed journals) in the field of translational medicine and biomaterials
Author: Benjamin E. Blass
Publisher: Academic Press
ISBN: 0128172150
Category : Medical
Languages : en
Pages : 712
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Book Description
Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator’s fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist’s early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry
Author: Martin Wehling
Publisher: Academic Press
ISBN: 032399962X
Category : Science
Languages : en
Pages : 495
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Book Description
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
Author: Lionel D. Edwards
Publisher: John Wiley & Sons
ISBN: 9780470093146
Category : Medical
Languages : en
Pages : 780
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Book Description
The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS
Author: Marianne J. Legato
Publisher: Academic Press
ISBN: 0128035420
Category : Medical
Languages : en
Pages : 792
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Book Description
The announcement that we had decoded the human genome in 2000 ushered in a new and unique era in biomedical research and clinical medicine. This Third Edition of Principles of Gender-Specific Medicine focuses, as in the past two editions, on the essentials of sexual dimorphism in human physiology and pathophysiology, but emphasizes the latest information about molecular biology and genomic science in a variety of disciplines. Thus, this edition is a departure from the previous two; the editor solicited individual manuscripts from innovative scientists in a variety of fields rather than the traditional arrangement of sections devoted to the various subspecialties of medicine edited by section chiefs. Wherever it was available, these authors incorporated the latest information about the impact of the genome and the elements that modify its expression on human physiology and illness. All chapters progress translationally from basic science to the clinical applications of gender-specific therapy and suggest the most important topics for future investigation. This book is essential reading for all biomedical investigators and medical educators involved in gender-specific medicine. It will also be useful for primary care practitioners who need information about the importance of sex and gender in the prevention, diagnosis and treatment of illness. Outlines sex-specific differences in normal human function and explains the impact of age, hormones, and environment on the incidence and outcome of illness Reflects the latest information about the molecular basis of the sexual dimorphism in human physiology and the experience of disease Reviews the implications of our ever-improving ability to describe the genetic basis of vulnerability to disease and our capacity to alter the genome itself Illustrates the importance of new NIH guidelines that urge the inclusion of sex as a variable in research protocols
Author: Anthony Atala
Publisher: Academic Press
ISBN: 9780123814234
Category : Science
Languages : en
Pages : 1202
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Book Description
Virtually any disease that results from malfunctioning, damaged, or failing tissues may be potentially cured through regenerative medicine therapies, by either regenerating the damaged tissues in vivo, or by growing the tissues and organs in vitro and implanting them into the patient. Principles of Regenerative Medicine discusses the latest advances in technology and medicine for replacing tissues and organs damaged by disease and of developing therapies for previously untreatable conditions, such as diabetes, heart disease, liver disease, and renal failure. Key for all researchers and instituions in Stem Cell Biology, Bioengineering, and Developmental Biology The first of its kind to offer an advanced understanding of the latest technologies in regenerative medicine New discoveries from leading researchers on restoration of diseased tissues and organs
