Immunotoxicology Strategies For Pharmaceutical Safety Assessment
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Author |
: Danuta J. Herzyk |
Publisher |
: John Wiley & Sons |
Total Pages |
: 433 |
Release |
: 2008-11-21 |
ISBN-10 |
: 9780470386378 |
ISBN-13 |
: 0470386371 |
Rating |
: 4/5 (78 Downloads) |
Synopsis Immunotoxicology Strategies for Pharmaceutical Safety Assessment by : Danuta J. Herzyk
An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates Helps readers understand the significance of the methods and approaches to immunotoxicology testing Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing
Author |
: William J. Brock |
Publisher |
: John Wiley & Sons |
Total Pages |
: 492 |
Release |
: 2013-04-29 |
ISBN-10 |
: 9780470745915 |
ISBN-13 |
: 0470745916 |
Rating |
: 4/5 (15 Downloads) |
Synopsis Nonclinical Safety Assessment by : William J. Brock
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Author |
: Shayne Cox Gad |
Publisher |
: Wiley |
Total Pages |
: 0 |
Release |
: 1994-11-10 |
ISBN-10 |
: 0471283851 |
ISBN-13 |
: 9780471283850 |
Rating |
: 4/5 (51 Downloads) |
Synopsis Safety Assessment for Pharmaceuticals by : Shayne Cox Gad
This practical, comprehensive resource provides the strategic tools necessary for designing an up-to-date safety assessment program, and gives you the practical tools you need to implement it. The book includes a comprehensive discussion of regulatory requirements, project management essentials, screens and phasing, along with highly specific advice on testing and assessment from acknowledged experts in toxicology. Every major test methodology is covered: Acute, chronic, and subchronic toxicity studies. Developmental and reproductive toxicity testing. Pulmonary assessment. Irritation and local tissue tolerance testing. Current topics are included, from immunotoxicology, to nonrodent experiment design, to the future of In Vitro techniques. Avoiding dry mathematical and theoretical discussion in favor of practical guidance, this is the best reference available for understanding and performing safety assessments.
Author |
: Shayne Cox Gad |
Publisher |
: John Wiley & Sons |
Total Pages |
: 918 |
Release |
: 2016-11-18 |
ISBN-10 |
: 9781119097402 |
ISBN-13 |
: 1119097401 |
Rating |
: 4/5 (02 Downloads) |
Synopsis Drug Safety Evaluation by : Shayne Cox Gad
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author |
: William J. Brock |
Publisher |
: John Wiley & Sons |
Total Pages |
: 492 |
Release |
: 2013-03-05 |
ISBN-10 |
: 9781118516980 |
ISBN-13 |
: 1118516982 |
Rating |
: 4/5 (80 Downloads) |
Synopsis Nonclinical Safety Assessment by : William J. Brock
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Author |
: Helen Tryphonas |
Publisher |
: CRC Press |
Total Pages |
: 480 |
Release |
: 2005-01-27 |
ISBN-10 |
: 0415308542 |
ISBN-13 |
: 9780415308540 |
Rating |
: 4/5 (42 Downloads) |
Synopsis Investigative Immunotoxicology by : Helen Tryphonas
Investigative Immunotoxicology provides a critical evaluation of proposed experimental animal models and approaches, and discusses the contribution that immunotoxicity can make to the overall assessment of chemical-induced adverse health effects on humans and the ecosystem. Following a review of general concepts in immunotoxicology, the book discusses emerging methodologies at the cellular and molecular levels, and describes advances in and requirements for animal model development in testing the allergenicity of foods and genetically modified products. It presents animal models of autoimmunity associated with chemical exposure, includes recommendations for the selection of sentinel species in ecotoxicology, and presents an in-depth review of immunotoxicology as it relates to a variety of wildlife species. Finally, the book explains the role of immunotoxicology in human health risk assessment and the regulatory process. Outlining the potential chemical hazards facing human and ecosystem health, this is a valuable reference for professionals and researchers in immunotoxicology and risk assessment. It also deserves the attention of the pharmaceutical industry and environmental toxicologists who are concerned about the effects of xenobiotics on ecosystems.
Author |
: Anthony C. Cartwright |
Publisher |
: CRC Press |
Total Pages |
: 804 |
Release |
: 2016-04-19 |
ISBN-10 |
: 9781420081831 |
ISBN-13 |
: 1420081837 |
Rating |
: 4/5 (31 Downloads) |
Synopsis International Pharmaceutical Product Registration by : Anthony C. Cartwright
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author |
: Joerg Bluemel |
Publisher |
: Academic Press |
Total Pages |
: 716 |
Release |
: 2015-03-13 |
ISBN-10 |
: 9780124171466 |
ISBN-13 |
: 012417146X |
Rating |
: 4/5 (66 Downloads) |
Synopsis The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by : Joerg Bluemel
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
Author |
: Ronald D Hood |
Publisher |
: CRC Press |
Total Pages |
: 872 |
Release |
: 2016-04-19 |
ISBN-10 |
: 9781841848211 |
ISBN-13 |
: 1841848212 |
Rating |
: 4/5 (11 Downloads) |
Synopsis Developmental and Reproductive Toxicology by : Ronald D Hood
Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers e
Author |
: Ali S. Faqi |
Publisher |
: Academic Press |
Total Pages |
: 903 |
Release |
: 2012-10-18 |
ISBN-10 |
: 9780123878168 |
ISBN-13 |
: 0123878160 |
Rating |
: 4/5 (68 Downloads) |
Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source