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A Comprehensive Guide To Toxicology In Nonclinical Drug Development

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2016-11-03
ISBN : 0128036214
Language : En, Es, Fr & De

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Book Description :

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with 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 the expectations associated with working in nonclinical toxicology

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2012-11-16
ISBN : 0123878152
Language : En, Es, Fr & De

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Book Description :

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

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book
Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard F. Weinbauer
Publisher : Academic Press
Release : 2015-03-12
ISBN : 9780124171442
Language : En, Es, Fr & De

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Book Description :

Annotation This reference compiles 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, it provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing.

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development Book
Author : Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
Publisher : CRC Press
Release : 2020-12-23
ISBN : 0429648499
Language : En, Es, Fr & De

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Book Description :

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first 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. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

Essentials of Laboratory Animal Science Principles and Practices

Essentials of Laboratory Animal Science  Principles and Practices Book
Author : P. Nagarajan,Ramachandra Gudde,Ramesh Srinivasan
Publisher : Springer Nature
Release : 2021-08-24
ISBN : 981160987X
Language : En, Es, Fr & De

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Book Description :

This book comprehensively reviews the anatomy, physiology, genetics and pathology of laboratory animals as well as the principles and practices of using laboratory animals for biomedical research.It covers the design of buildings used for laboratory animals, quality control of laboratory animals, and toxicology, and discusses various animal models used for human diseases. It also highlights aspects, such as handling and restraint and administration of drugs, as well as breeding and feeding of laboratory animals, and provides guidelines for developing meaningful experiments using laboratory animals.Further, the book discusses various alternatives to animal experiments for drug and chemical testing, including their advantages over the current approaches. Lastly, it examines the potential effect of harmful pathogens on the physiology of laboratory animals and discusses the state of art in in vivo imaging techniques.The book is a useful resource for research scientists, laboratory animal veterinarians, and students of laboratory animal medicine.

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book
Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Release : 2015-03-13
ISBN : 012417146X
Language : En, Es, Fr & De

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Book Description :

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

Botanical Drug Products

Botanical Drug Products Book
Author : Jayant N. Lokhande,Yashwant V. Pathak
Publisher : CRC Press
Release : 2018-11-21
ISBN : 1315352281
Language : En, Es, Fr & De

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Book Description :

Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process.

Drug Discovery and Development Third Edition

Drug Discovery and Development  Third Edition Book
Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publisher : CRC Press
Release : 2019-12-13
ISBN : 1351625136
Language : En, Es, Fr & De

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Book Description :

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Nonclinical Drug Administration

Nonclinical Drug Administration Book
Author : Shayne C. Gad,Charles B. Spainhour
Publisher : CRC Press
Release : 2017-08-14
ISBN : 1466502592
Language : En, Es, Fr & De

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Book Description :

If we will ever achieve Paul Ehrlich’s "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos," those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology. The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity. The book’s ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.

Preclinical Development Handbook

Preclinical Development Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 9780470249048
Language : En, Es, Fr & De

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Book Description :

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Development and Approval of Combination Products

Development and Approval of Combination Products Book
Author : Evan B. Siegel
Publisher : John Wiley & Sons
Release : 2008-06-09
ISBN : 0470371196
Language : En, Es, Fr & De

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Book Description :

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.

Antibody Drug Conjugates

Antibody Drug Conjugates Book
Author : Kenneth J. Olivier, Jr.,Sara A. Hurvitz
Publisher : Wiley
Release : 2016-11-21
ISBN : 9781119060680
Language : En, Es, Fr & De

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Book Description :

Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development

Accelerated Path to Cures

Accelerated Path to Cures Book
Author : Josep Bassaganya-Riera
Publisher : Springer
Release : 2018-04-25
ISBN : 3319732382
Language : En, Es, Fr & De

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Book Description :

Accelerated Path to Cures provides a transformative perspective on the power of combining advanced computational technologies, modeling, bioinformatics and machine learning approaches with nonclinical and clinical experimentation to accelerate drug development. This book discusses the application of advanced modeling technologies, from target identification and validation to nonclinical studies in animals to Phase 1-3 human clinical trials and post-approval monitoring, as alternative models of drug development. As a case of successful integration of computational modeling and drug development, we discuss the development of oral small molecule therapeutics for inflammatory bowel disease, from the application of docking studies to screening new chemical entities to the development of next-generation in silico human clinical trials from large-scale clinical data. Additionally, this book illustrates how modeling techniques, machine learning, and informatics can be utilized effectively at each stage of drug development to advance the progress towards predictive, preventive, personalized, precision medicine, and thus provide a successful framework for Path to Cures.

Developmental and Reproductive Toxicology

Developmental and Reproductive Toxicology Book
Author : Ronald D Hood
Publisher : CRC Press
Release : 2011-12-14
ISBN : 9781841847771
Language : En, Es, Fr & De

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Book Description :

The purpose of this third edition of Developmental and Reproductive Toxicology is to provide a practical guide to developmental and reproductive toxicology in a regulatory environment. In addition to a comprehensive update of current chapters, the third edition been revised to reflect recent changes in the field. It contains new chapters that reflect emerging topics of interest, including testing of biologics (including vaccines), nonhuman primates as nonclinical models, developmental immunotoxicity testing, in vitro assays (such as use of zebrafish and stem cells, as well as high throughput screening), in silico systems modelling, evaluating mechanisms of reproductive toxicity, in-depth coverage of neurobehavioral testing, and testing under the EU’s REACH regulations, as well as updated chapters on nonclinical juvenile toxicity testing, endocrine disruptor screening, and on functional and computational genomics. The study of hazard and risk associated with exposure to toxicants during prenatal development has been expanded in recent years to include effects on development until the time of puberty. Concern over the adverse effects of chemical or physical agents on the reproductive processes of both sexes has increased, and progress has been made in identifying the causes and mechanisms eliciting congenital defects and determining the genetic, epigenetic, and environmental factors involved. This book provides up-to-date guidance on the use and interpretation of the newest research techniques in developmental and reproductive toxicology, as well as the more traditional approaches. Developmental and Reproductive Toxicology, Third Edition: Contains valuable insights gained from hands-on experience, together with a critical evaluation of current testing strategies. Includes guidance for the design, conduct, and interpretation of tests in all areas of developmental and reproductive toxicity. Contains reprinted guidelines from major regulatory agencies, as well as terminology for description of developmental abnormalities in laboratory animals, for easy reference. Provides guidance for planning and conducting preclinical toxicity studies and follow-up studies, and interpreting their results in a regulatory environment. This book continues to be the ideal practical reference for developmental and reproductive toxicologists who perform research in industry, government, and academia and for anyone who intends to enter these research areas.

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice Book
Author : Alberto Lodola,Jeanne Stadler
Publisher : John Wiley & Sons
Release : 2011-03-31
ISBN : 0470922729
Language : En, Es, Fr & De

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Book Description :

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Medical Writing in Drug Development

Medical Writing in Drug Development Book
Author : Robert J. Bonk
Publisher : Routledge
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

A guide through the maze of the pharmaceutical research and development process, Medical Writing in Drug Development fills a gap in the libraries of technical writers, college instructors, and corporate professionals associated with the pharmaceutical process. As it discusses critical information, such as strategies and techniques pivotal to crafting documents for drug development, it also overviews drug research, document types, the roles of professional writers, and information technology. In no time at all, you will be creating persuasive technical documents, building complex facts into coherent messages, and contributing to the effective marketing of new products with promotional pieces that meet legal and ethical standards. Medical Writing in Drug Development helps medical writers and scientific, regulatory, and marketing professionals develop a working knowledge of the technical documents crucial to successful drug research. New and seasoned professional writers alike will benefit from the book's detailed discussions of: using abstracts, slides, and posters to present up-to-the-minute research how patient-education materials, health-economic assessments, and electronic journals provide ongoing challenges in medical writing a dossier approach that expedites regulatory submissions for international drug development structural constraints and rhetorical approaches toward regulatory documents presenting intricate information in scientifically unbiased, yet technically convincing language the effects of electronic publishing, computer graphics, and related technology on the practice of medical writing within pharmaceutical research Practical as a foundation text for undergraduate, graduate, and certificate programs in pharmaceutical or medical technical writing, Medical Writing in Drug Development will help you develop practical strategies for handling journal manuscripts, conference materials, and promotional pieces. No other text will clarify the main aspects of the pharmaceutical research and development process while offering you insight on the key issues dominating the healthcare arena.

New Drug Development

New Drug Development Book
Author : Mark P. Mathieu,Anne G. Evans,Parexel International Corporation
Publisher : Parexel International Corporation
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download New Drug Development book written by Mark P. Mathieu,Anne G. Evans,Parexel International Corporation, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Comprehensive Toxicology Toxicological testing and evaluation

Comprehensive Toxicology  Toxicological testing and evaluation Book
Author : I. Glenn Sipes
Publisher : Unknown
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Comprehensive Toxicology Toxicological testing and evaluation book written by I. Glenn Sipes, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Integrated Cardiac Safety

Integrated Cardiac Safety Book
Author : J. Rick Turner,Todd A. Durham
Publisher : Wiley
Release : 2008-11-26
ISBN : 0470411287
Language : En, Es, Fr & De

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Book Description :

The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.

Biotechnology Operations

Biotechnology Operations Book
Author : Michael J. Roy
Publisher : CRC Press
Release : 2011-06-27
ISBN : 1439830282
Language : En, Es, Fr & De

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Book Description :

Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.