Toxicolog A Cl Nica
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Translational Medicine
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Author : Joy A. Cavagnaro
language : en
Publisher: CRC Press
Release Date : 2021-11-26
Translational Medicine written by Joy A. Cavagnaro and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-26 with Medical categories.
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.
Quality Criteria For Water 1986
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Author : United States. Environmental Protection Agency. Office of Water Regulations and Standards
language : en
Publisher:
Release Date : 1986
Quality Criteria For Water 1986 written by United States. Environmental Protection Agency. Office of Water Regulations and Standards and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1986 with Water categories.
Section 304(a) (1) of the Clean Water Act 33 U.S.C. 1314(a) (1) requires the Environmental Protection Agency (EPA) to publish and periodically update ambient water quality criteria. These criteria are to accurately reflect the latest scientific knowledge (a) on the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish shellfish, wildlife, plant life, shorelines, beaches, aesthetics, and recreation which may be expected from the presence of pollutants in any body of water including ground water; (b) on the concentration and dispersal of pollutants, or their byproducts, through biological, physical, and chemical processes; and (c) on the effects of pollutants on biological community diversity, productivity, and stability, including information on the factors affecting rates of eutrophication and organic and inorganic sedimentation for varying types of receiving waters. In a continuing effort to provide those who use EPA's water quality and human health criteria with up-to-date criteria values and associated information, the document was assembled. The document includes summaries of all the contaminants for which EPA has developed criteria recommendations.
Handbook On The Toxicology Of Metals
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Author : Monica Nordberg
language : en
Publisher: Elsevier
Release Date : 2011-04-28
Handbook On The Toxicology Of Metals written by Monica Nordberg and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-28 with Science categories.
Handbook of the Toxicology of Metals is the standard reference work for physicians, toxicologists and engineers in the field of environmental and occupational health. This new edition is a comprehensive review of the effects on biological systems from metallic elements and their compounds. An entirely new structure and illustrations represent the vast array of advancements made since the last edition. Special emphasis has been placed on the toxic effects in humans with chapters on the diagnosis, treatment and prevention of metal poisoning. This up-to-date reference provides easy access to a broad range of basic toxicological data and also gives a general introduction to the toxicology of metallic compounds. * Covers up-to-date toxicological information on 31 metallic elements and their compounds, each in a separate chapter * New chapters on general chemistry, biological monitoring and biomarkers, essential metals, principles for prevention of the toxic effects of metals, and more
Handbook On The Toxicology Of Metals
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Author : Gunnar F. Nordberg
language : en
Publisher: Academic Press
Release Date : 2014-08-07
Handbook On The Toxicology Of Metals written by Gunnar F. Nordberg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-07 with Medical categories.
Handbook on the Toxicology of Metals, Fourth Edition bridges the gap between established knowledgebase and new advances in metal toxicology to provide one essential reference for all those involved in the field. This book provides comprehensive coverage of basic toxicological data, emphasizing toxic effects primarily in humans, but also those of animals and biological systems in vitro. The fourth edition also contains several new chapters on important topics such as nanotoxicology, metals in prosthetics and dental implants, gene-environment interaction, neurotoxicology, metals in food, renal, cardiovascular, and diabetes effects of metal exposures and more. Volume I covers “General Considerations and Volume II is devoted to “Specific Metals. A multidisciplinary resource with contributions from internationally-recognized experts, the fourth edition of the Handbook on the Toxicology of Metals is a prominent and indispensable reference for toxicologists, physicians, pharmacologists, engineers, and all those involved in the toxicity of metals. Contains 61 peer reviewed chapters dealing with the effects of metallic elements and their compounds on biological systems Includes information on sources, transport and transformation of metals in the environment and on certain aspects of the ecological effects of metals to provide a basis for better understanding of the potential for adverse effects on human health Covers the toxicology of metallic nanomaterials in a new comprehensive chapter Metal toxicology in developing countries is dealt with in another new chapter emphasizing the adverse effects on human health by the inadequate handling of "ewaste Other new chapters in the 4th edition include: Toxic metals in food; Toxicity of metals released from medical devices; Gene-environment interactions; Neurotoxicology of metals; Cardiovascular disease; Renal effects of exposure to metals; Gold and gold mining; Iridium; Lanthanum; Lithium and Rhodium
Reviews Of Environmental Contamination And Toxicology Volume 225
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Author : David M. Whitacre
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-03-15
Reviews Of Environmental Contamination And Toxicology Volume 225 written by David M. Whitacre and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-15 with Science categories.
Reviews of Environmental Contamination and Toxicology attempts to provide concise, critical reviews of timely advances, philosophy and significant areas of accomplished or needed endeavor in the total field of xenobiotics, in any segment of the environment, as well as toxicological implications.
Drug Discovery Toxicology
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Author : Yvonne Will
language : en
Publisher: John Wiley & Sons
Release Date : 2016-03-22
Drug Discovery Toxicology written by Yvonne Will and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-03-22 with Medical categories.
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
Environmental Toxicology And Chemistry
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Author :
language : en
Publisher:
Release Date : 2007
Environmental Toxicology And Chemistry written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Environmental chemistry categories.
Medical Eligibility Criteria For Contraceptive Use
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Author :
language : en
Publisher: World Health Organization
Release Date : 2010
Medical Eligibility Criteria For Contraceptive Use written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Business & Economics categories.
Medical Eligibility Criteria for Contraceptive Use reviews the medical eligibility criteria for use of contraception, offering guidance on the safety and use of different methods for women and men with specific characteristics or known medical conditions. The recommendations are based on systematic reviews of available clinical and epidemiological research. It is a companion guideline to Selected Practice Recommendations for Contraceptive Use. Together, these documents are intended to be used by policy-makers, program managers, and the scientific community to support national programs in the preparation of service delivery guidelines. The fourth edition of this useful resource supersedes previous editions, and has been fully updated and expanded. It includes over 86 new recommendations and 165 updates to recommendations in the previous edition. Guidance for populations with special needs is now provided, and a new annex details evidence on drug interactions from concomitant use of antiretroviral therapies and hormonal contraceptives. To assist users familiar with the third edition, new and updated recommendations are highlighted. Everyone involved in providing family planning services and contraception should have the fourth edition of Medical Eligibility Criteria for Contraceptive Use at hand.
Drug Safety Evaluation
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Author : Shayne C. Gad
language : en
Publisher: Wiley-Interscience
Release Date : 2002-04-18
Drug Safety Evaluation written by Shayne C. Gad and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-04-18 with Medical categories.
Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity.
Therapeutic Oligonucleotides
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Author : Jens Kurreck
language : en
Publisher: Royal Society of Chemistry
Release Date : 2008
Therapeutic Oligonucleotides written by Jens Kurreck and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Medical categories.
This book provides a compelling overall update on current status of RNA interference