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Author: Yvonne Will
Publisher: John Wiley & Sons
ISBN: 1119053390
Category : Medical
Languages : en
Pages : 899
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Book Description
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
Author: Yvonne Will
Publisher: John Wiley & Sons
ISBN: 1119053390
Category : Medical
Languages : en
Pages : 899
Get Book Here
Book Description
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
Author: Ernest Hodgson
Publisher: Academic Press
ISBN: 0124158137
Category : Medical
Languages : en
Pages : 452
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Book Description
Environmental toxicology is generally held to be the study of the potential of constituents of outdoor environments to impact either human health or the biological structure of the ecosystems involved. This volume is a first attempt to integrate toxicological studies of all of the many human environments, both indoor and outdoor, and their complex interrelationships. Included are considerations of natural environments, the agroecosystem, occupational, urban and domestic environments as well as the environment associated with Superfund sites and military deployments. The primary emphasis is on public health, including the potential health effects of toxicants found in different environments, the bioprocessing of such toxicants in humans and surrogate animals and the principles of risk analysis. Approaches the toxicology of human environments in a new and unique way, stressing the complex interrelationships of all human environments and the implication for human and environmental health Each chapter is written by an acknowledged expert and is addressed to those interested in the broader implications of the environmental modifications that are always associated with the activities of humans living and working in them
Author: Martin Wehling
Publisher: Academic Press
ISBN: 0128007214
Category : Science
Languages : en
Pages : 365
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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: Rebecca Fry
Publisher: Academic Press
ISBN: 0128199687
Category : Medical
Languages : en
Pages : 366
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Book Description
Environmental Epigenetics in Toxicology and Public Health provides in-depth discussions of the suite of complex environmental factors shown to impact epigenetic components within the cell, as well as evidence that these epigenetic modifications are tied to early and later life health effects. This book offers a translational research perspective, highlighting both in vivo and human population-based evidence for ties between the environment, the epigenome, and health outcomes, with an emphasis on evidence for transgenerational effects of exposures, as well as developmental windows of susceptibility to environmentally-linked epigenetic effects. This volume in the Translational Epigenetics series aides in the development of new therapeutic options meant to reverse inappropriate epigenetic alterations, helping researchers in their efforts prevent and treat a variety of chronic diseases tied to environmental exposures.
Author: Joy A. Cavagnaro
Publisher: CRC Press
ISBN: 1000471829
Category : Medical
Languages : en
Pages : 543
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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: Claude L. Hughes
Publisher: Humana Press
ISBN: 331927449X
Category : Medical
Languages : en
Pages : 384
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Book Description
Bringing together a distinguished interdisciplinary team of contributors, this volume provides a comprehensive exploration of translational toxicology—a systematic approach to developing therapeutic interventions that can protect against, mitigate, or reverse the effects of exposures. In particular, the book addresses modes of action and biomarkers, developmental risks of exposures, and potential translational toxicology therapeutics. The result is a compelling application of developmental toxicology in a new therapeutic discipline that is destined to become part of standard medical practice. Translational Toxicology: Defining a New Therapeutic Discipline is an essential text for regulatory authorities, scientists, and physicians who are concerned with environmental exposures, public health, nutrition, and pharmaceutical research and development. Basic science, epidemiological, and clinical investigators will also find this book a significant resource.
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: Bruce Anderson
Publisher: Elsevier
ISBN: 0080548008
Category : Medical
Languages : en
Pages : 6651
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Book Description
The second edition of the Encyclopedia of Toxicology continues its comprehensive survey of toxicology. This new edition continues to present entries devoted to key concepts and specific chemicals. There has been an increase in entries devoted to international organizations and well-known toxic-related incidents such as Love Canal and Chernobyl. Along with the traditional scientifically based entries, new articles focus on the societal implications of toxicological knowledge including environmental crimes, chemical and biological warfare in ancient times, and a history of the U.S. environmental movement. With more than 1150 entries, this second edition has been expanded in length, breadth and depth, and provides an extensive overview of the many facets of toxicology. Also available online via ScienceDirect – featuring extensive browsing, searching, and internal cross-referencing between articles in the work, plus dynamic linking to journal articles and abstract databases, making navigation flexible and easy. For more information, pricing options and availability visit www.info.sciencedirect.com. *Second edition has been expanded to 4 volumes *Encyclopedic A-Z arrangement of chemicals and all core areas of the science of toxicology *Covers related areas such as organizations, toxic accidents, historical and social issues, and laws *New topics covered include computational toxicology, cancer potency factors, chemical accidents, non-lethal chemical weapons, drugs of abuse, and consumer products and many more!
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309109922
Category : Nature
Languages : en
Pages : 217
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Book Description
Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.
Author: Divya Vohora
Publisher: Academic Press
ISBN: 0128020989
Category : Medical
Languages : en
Pages : 527
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Book Description
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
