Global Approach In Safety Testing
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Global Approach In Safety Testing
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Author : Jan Willem van der Laan
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-02-11
Global Approach In Safety Testing written by Jan Willem van der Laan 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 2013-02-11 with Medical categories.
This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.
Validation Of Alternative Methods For Toxicity Testing
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Author : Chantra Eskes
language : en
Publisher: Springer
Release Date : 2016-09-26
Validation Of Alternative Methods For Toxicity Testing written by Chantra Eskes and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-26 with Medical categories.
This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
The Interplay Of Global Standards And Eu Pharmaceutical Regulation
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Author : Sabrina Röttger-Wirtz
language : en
Publisher: Bloomsbury Publishing
Release Date : 2021-08-26
The Interplay Of Global Standards And Eu Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-26 with Law categories.
This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment
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Author : Joerg Bluemel
language : en
Publisher: Academic Press
Release Date : 2015-03-13
The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment written by Joerg Bluemel and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-13 with Medical categories.
The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes
Current Topics In Nonclinical Drug Development
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Author : Philip Bentley
language : en
Publisher: CRC Press
Release Date : 2023-11-03
Current Topics In Nonclinical Drug Development written by Philip Bentley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-03 with Science categories.
The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second 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. Select topics include: Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology. Current approaches to carcinogenicity testing. Predicting drug-drug interactions. Current understanding of idiosyncratic drug reaction. Assessing cardiovascular risks beyond QT interval. Use of 3D cell cultures in toxicology and ADME. Development of small molecule-antibody complexes. Differentiating adverse from non-adverse findings in nonclinical studies. Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Business America
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Author :
language : en
Publisher:
Release Date : 1991
Business America written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991 with Business categories.
Includes articles on international business opportunities.
Public Health And Toxicology Issues In Drug Research Volume 2
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Author : Rakesh Kumar Tekade
language : en
Publisher: Elsevier
Release Date : 2024-04-05
Public Health And Toxicology Issues In Drug Research Volume 2 written by Rakesh Kumar Tekade and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-05 with Medical categories.
Toxicodynamics in Drug Research, Volume 2: Public Health and Toxicology Issues examines the implications of public health issues and the impact of pharmaceuticals, chemical and food toxicants, dietary phytochemicals, and medical treatments on human health. Volume 2: Public Health and Toxicology Issues in Drug Research: Toxicity and Toxicodynamics covers topics on pharmacokinetics and toxicokinetics such as population pharmacokinetics/toxicokinetics, the design of toxicokinetic studies, and the use of toxicokinetic data in preclinical safety assessments. The book investigates the health effect caused by the bioaccumulation of pharmaceutical and personal care products and the impact of drug-induced toxicity on different systems of the body. It discusses the mechanistic pathways of food toxicants and illustrates the molecular mechanisms of the chemopreventive role of dietary phytochemicals. It also delves into the toxic effects of medical treatments and materials. Ethical, legal, societal, and professional issues in toxicology round off the coverage providing a valuable resource to interested in learning more about the health impact and public health issues related to the toxicity of pharmaceuticals, dietary supplements, personal care products, and medical treatments. Discusses the impact of pharmaceuticals, food, and chemical toxicants on human health Examines the toxic effects of medical treatments, clinical administrations, and materials Explores public health issues around drug safety and toxicology
International Marketing
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Author : John Shaw
language : en
Publisher: Routledge
Release Date : 2008-01-28
International Marketing written by John Shaw and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-01-28 with Business & Economics categories.
Marketing is a universal activity that is widely applicable, regardless of the political, social or economic systems of a particular country. However, this doesn't mean that consumers in different parts of the world should be satisified in the same way. The 4th edition of International Marketing has been written to enable managers and scholars to meet the international challenges they face everyday. It provides the solid foundation required to understand the complexities of marketing on a global scale. The book has been fully updated with topical case studies, examples of contemporary marketing campaigns, the most relevant discussion topics as well as the most up-to-date theories, references and research findings. It is this combination of theory and practice that makes this textbook truly unique, presenting a fully rounded view of the topic rather than an anecodotal or descriptive one alone. The book includes chapters on: * Trade distortions and marketing barriers * Political and legal environments * Culture * Consumer behaviour * Marketing research * Promotion and pricing strategies * Currencies and foreign exchange Accessibly written and designed, this book is the most international book on marketing available that can be used by undergraduates and postgraduates the world over. A companion website provides additional material for lecturers and students alike.
Engineering A Safer World
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Author : Nancy G. Leveson
language : en
Publisher: MIT Press
Release Date : 2012-01-13
Engineering A Safer World written by Nancy G. Leveson and has been published by MIT Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-13 with Science categories.
A new approach to safety, based on systems thinking, that is more effective, less costly, and easier to use than current techniques. Engineering has experienced a technological revolution, but the basic engineering techniques applied in safety and reliability engineering, created in a simpler, analog world, have changed very little over the years. In this groundbreaking book, Nancy Leveson proposes a new approach to safety—more suited to today's complex, sociotechnical, software-intensive world—based on modern systems thinking and systems theory. Revisiting and updating ideas pioneered by 1950s aerospace engineers in their System Safety concept, and testing her new model extensively on real-world examples, Leveson has created a new approach to safety that is more effective, less expensive, and easier to use than current techniques. Arguing that traditional models of causality are inadequate, Leveson presents a new, extended model of causation (Systems-Theoretic Accident Model and Processes, or STAMP), then shows how the new model can be used to create techniques for system safety engineering, including accident analysis, hazard analysis, system design, safety in operations, and management of safety-critical systems. She applies the new techniques to real-world events including the friendly-fire loss of a U.S. Blackhawk helicopter in the first Gulf War; the Vioxx recall; the U.S. Navy SUBSAFE program; and the bacterial contamination of a public water supply in a Canadian town. Leveson's approach is relevant even beyond safety engineering, offering techniques for “reengineering” any large sociotechnical system to improve safety and manage risk.
Competitive Strategies In Life Sciences
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Author : Basanta Kumara Behera
language : en
Publisher: Springer Nature
Release Date : 2020-10-21
Competitive Strategies In Life Sciences written by Basanta Kumara Behera and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-21 with Science categories.
Tailoring of biomolecules using protein engineering technology, and host cells culture techniques are among the most sophisticated and elegant achievements of modern applied life sciences in which the basic fundamentals biotechnology are applicable for the development and manufacturing of biologics and other related bio-molecules for a hurdle free life with good health. A majority of biologics derived from genetically modified host cells in the current market are bio-formulation such as antibodies, nucleic acid products and vaccines. Such bio-formulations are developed mainly in two steps i.e. upstream process and downstream process. The first volume of this series begins with the latest information on how the classical stepwise host cells culture (mammals, animals, plants, and bacteria) methodology has been changed to fully continuous or partially continuous host cells culture process in order to economise the biopharmaceutical products manufacturing process. In addition this volume narrates a brief history on conceptual development of new thoughts in designing biotechnology industries for commercial production of variety of therapeutic proteins with structural modification on the basis of clinical requirements. The readers will feel exited by going through the latest discovery and development in applied life sciences for designing innovative biomolecules for health care with utmost safe. The most interesting part of this volume is newly developed concept on bioprinting. It explains how to design and fabricate animate objects by fusing or depositing material of interest in the form of powders, solid dusts, metal, liquid or even living cells or tissues by layers to produce 3D objectives. The first volume ends with the latest information on the current trend in biologics market, market dynamic, drives, and opportunities with challenges.