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Immunotoxicology Strategies For Pharmaceutical Safety Assessment
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Book Synopsis Immunotoxicology Strategies for Pharmaceutical Safety Assessment by : Danuta J. Herzyk
Download or read book Immunotoxicology Strategies for Pharmaceutical Safety Assessment written by Danuta J. Herzyk and published by John Wiley & Sons. This book was released on 2008-11-21 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Nonclinical Safety Assessment by : William J. Brock
Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-03-05 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Safety Assessment for Pharmaceuticals by : Shayne Cox Gad
Download or read book Safety Assessment for Pharmaceuticals written by Shayne Cox Gad and published by Wiley. This book was released on 1994-11-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Immunotoxicity Testing by : Rodney R. Dietert
Download or read book Immunotoxicity Testing written by Rodney R. Dietert and published by Humana Press. This book was released on 2010-02-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent critical advances in the field of immunotoxicology have led to incredible contributions to basic science, including crucial improvements in human risk assessment. In Immunotoxicity Testing: Methods and Protocols, expert researchers explore these changes, providing the reader with current, lab-ready procedures, along with the corresponding background information that is necessary to identify effective testing approaches for chemicals and drugs. Among the first volumes to meld consideration of immunotoxicity testing strategies with a comprehensive presentation of detailed laboratory protocols, chapters include a description of the evolution of immunotoxicity testing, a look at the importance of immunotoxicity testing for health risk reduction, and ideas concerning the future of the field. Composed in the highly successful Methods in Molecular Biology(tm) series format, most chapters contain a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips from the experts on troubleshooting and avoiding known pitfalls. Comprehensive and innovative, Immunotoxicity Testing: Methods and Protocols is a critical, one-stop reference resource for the most important and commonly used laboratory protocols in immunotoxicology.
Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis International Pharmaceutical Product Registration by : Anthony C. Cartwright
Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by : Joerg Bluemel
Download or read book The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment written by Joerg Bluemel and published by Academic Press. This book was released on 2015-03-13 with total page 716 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Developmental and Reproductive Toxicology by : Ronald D Hood
Download or read book Developmental and Reproductive Toxicology written by Ronald D Hood and published by CRC Press. This book was released on 2016-04-19 with total page 872 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-10-18 with total page 903 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis A Comprehensive Guide to Toxicology in Nonclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Elsevier. This book was released on 2024-02-11 with total page 1074 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Author :Jan Willem van der Laan Publisher :Springer Science & Business Media ISBN 13 :1461459508 Total Pages :322 pages Book Rating :4.4/5 (614 download)
Book Synopsis Global Approach in Safety Testing by : Jan Willem van der Laan
Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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”.
Book Synopsis Molecular Immunotoxicology by : Emanuela Corsini
Download or read book Molecular Immunotoxicology written by Emanuela Corsini and published by John Wiley & Sons. This book was released on 2014-11-24 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: The human immune system is constantly exposed to chemical contaminants, whether from food, water or air. Some chemicals directly elicit an immune response, while others indirectly activate or deactivate components within the immune system. Thus when tracking or predicting the effect of a chemical on the immune system, many different pathways and modes of action need to be considered. Following an introduction to the various pathways and toxicity mechanisms from a systemic perspective, the main part of this comprehensive reference surveys individual molecular mechanisms of important immunotoxicants, from PAHs to biopharmaceuticals, and from receptor-mediated toxicity to nanoparticle toxicity, using analyses based on molecular effects rather than on animal models. Taken together, the knowledge presented here provides an up-to-date overview of this hot topic that can be directly applied to the prediction and characterization of immunotoxic effects in drugs, chemicals, and environmental contaminants.
Book Synopsis Reproductive Toxicology by : Robert W. Kapp
Download or read book Reproductive Toxicology written by Robert W. Kapp and published by CRC Press. This book was released on 2016-04-19 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly examining the popular and expanding field of reproductive toxicology, this newly revised and expanded third edition provides the latest, cutting-edge scientific developments in this constantly evolving discipline. Reproductive Toxicology's contributors are experienced regulatory agency and Clinical Research Organization representatives w
Book Synopsis Drug Discovery Toxicology by : Yvonne Will
Download or read book Drug Discovery Toxicology written by Yvonne Will and published by John Wiley & Sons. This book was released on 2016-03-16 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Strategies for Protecting Your Child's Immune System by : Rodney R. Dietert
Download or read book Strategies for Protecting Your Child's Immune System written by Rodney R. Dietert and published by World Scientific. This book was released on 2010 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ch. 1. Toxicology 101 -- ch. 2. What's the risk -- ch. 3. The risk exercises -- ch. 4. Introduction to the immune system -- ch. 5. How the immune system develops -- ch. 6. The special conditions of pregnancy and the immune system -- ch. 7. The healthy immune system at work -- ch. 8. The dysfunctional immune system and its features -- ch. 9. Avenues for immune exposure -- ch. 10. Diseases stemming from prenatal and early life toxic exposures -- ch. 11. The disease progression matrix -- ch. 12. Categories of environmental, physical and psychological factors -- ch. 13. Prenatal strategies for preventing immune system damage -- ch. 14. Strategies to use during the first few years of life -- ch. 15. Undoing the damage of the past in adulthood -- ch. 16. Top 25 risks -- ch. 17. Other risk factors -- ch. 18. Postnatal triggers of disease - infections -- ch. 19. Postnatal triggers of disease - vaccinations -- ch. 20. Dietary factors that affect the immune system -- ch. 21. Hygiene and pets -- ch. 22. Developmental immunotoxicity testing - past, present and future
Book Synopsis Handbook of Toxicology by : Michael J. Derelanko
Download or read book Handbook of Toxicology written by Michael J. Derelanko and published by CRC Press. This book was released on 2014-03-07 with total page 1022 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics r
Book Synopsis Immunopathology in Toxicology and Drug Development by : George A. Parker
Download or read book Immunopathology in Toxicology and Drug Development written by George A. Parker and published by Springer. This book was released on 2017-03-28 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a fundamental understanding of immunopathology and immunopathologic processes, with particular attention to nonclinical toxicology studies. Chapters provide an overview of general immunobiology, cells of the immune system, signaling and effector molecules, and immunopathology assays. A companion volume, Immunopathology in Toxicology and Drug Development: Volume 2, Organ Systems, offers summaries of organ-specific immunobiology and immunopathology as well as common responses to xenobiotics. These informative and strategic books were created in response to the large segment of drug development that focuses on chronic diseases, many of which involve alterations to the immune system. Therapies that target these diseases commonly involve some form of immunomodulation. As a result, the two volumes of Immunopathology in Toxicology and Drug Development are critical texts for individuals involved in diverse aspects of drug development. Readers will acquire a thorough understanding of immunopathology for detection and accurate interpretation of pathologic effects of xenobiotics on the immune system.
