A Comprehensive Guide To Toxicology In Nonclinical Drug Development

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Ali S. Faqi
A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book PDF

Author : Ali S. Faqi
Publisher : Elsevier
Page : 1074 pages
File Size : 42,5 Mb
Release : 2024-02-11
Category : Medical
ISBN : 9780323984621

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf

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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Ali S. Faqi
A Comprehensive Guide to Toxicology in Preclinical Drug Development Book PDF

Author : Ali S. Faqi
Publisher : Academic Press
Page : 904 pages
File Size : 45,6 Mb
Release : 2012-11-02
Category : Business & Economics
ISBN : 9780123878151

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A Comprehensive Guide to Toxicology in Preclinical Drug Development by Ali S. Faqi Pdf

A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Ali S. Faqi
A Comprehensive Guide to Toxicology in Preclinical Drug Development Book PDF

Author : Ali S. Faqi
Publisher : Academic Press
Page : 1024 pages
File Size : 40,5 Mb
Release : 2012-10-18
Category : Medical
ISBN : 9780123878168

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A Comprehensive Guide to Toxicology in Preclinical Drug Development by Ali S. Faqi Pdf

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

Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book PDF

Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Page : 716 pages
File Size : 53,9 Mb
Release : 2015-03-13
Category : Medical
ISBN : 9780124171466

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment by Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer Pdf

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

Nonclinical Safety Assessment

William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Nonclinical Safety Assessment Book PDF

Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Page : 492 pages
File Size : 55,8 Mb
Release : 2013-04-29
Category : Medical
ISBN : 9780470745915

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Nonclinical Safety Assessment by William J. Brock,Kenneth L. Hastings,Kathy M. McGown Pdf

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.

Drug Safety Evaluation

Shayne Cox Gad
Drug Safety Evaluation Book PDF

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 918 pages
File Size : 43,8 Mb
Release : 2016-11-18
Category : Medical
ISBN : 9781119097402

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Drug Safety Evaluation by Shayne Cox Gad Pdf

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

Early Drug Development

Mitchell N. Cayen
Early Drug Development Book PDF

Author : Mitchell N. Cayen
Publisher : John Wiley & Sons
Page : 654 pages
File Size : 53,6 Mb
Release : 2011-02-25
Category : Medical
ISBN : 1118035208

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Early Drug Development by Mitchell N. Cayen Pdf

The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Developmental and Reproductive Toxicology

Ali S. Faqi
Developmental and Reproductive Toxicology Book PDF

Author : Ali S. Faqi
Publisher : Humana Press
Page : 314 pages
File Size : 42,7 Mb
Release : 2017-08-18
Category : Medical
ISBN : 1493972065

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Developmental and Reproductive Toxicology by Ali S. Faqi Pdf

This meticulous volume covers metabolism and drug-drug interactions during pregnancy, critical periods of developmental toxicology, in vivo and alternative methods to assess potential developmental toxicity for drugs and chemicals, and effects of chemicals on testes and mammary glands. Evaluation of developmental and reproductive toxicology endpoints is an integral part of the safety assessment process for compounds with potential use in women of childbearing age or females that might be exposed during pregnancy as well as men of reproductive potential. The in vivo assessments included here are guideline-driven and are required for submissions for product approval. Written for the Methods in Pharmacology and Toxicology series, this collection includes the kind of detailed implementation advice necessary for success in the lab. Authoritative and practical, Developmental and Reproductive Toxicology is an ideal resource for researchers working in this vital field of study./div

Drug Discovery Toxicology

Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Drug Discovery Toxicology Book PDF

Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publisher : John Wiley & Sons
Page : 584 pages
File Size : 41,5 Mb
Release : 2016-03-22
Category : Medical
ISBN : 9781119053392

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Drug Discovery Toxicology by Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy Pdf

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

Anticancer Drug Development Guide

Beverly A. Teicher,Paul A. Andrews
Anticancer Drug Development Guide Book PDF

Author : Beverly A. Teicher,Paul A. Andrews
Publisher : Springer Science & Business Media
Page : 684 pages
File Size : 42,9 Mb
Release : 2004-02-01
Category : Medical
ISBN : 9781592597390

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Anticancer Drug Development Guide by Beverly A. Teicher,Paul A. Andrews Pdf

This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.

Principles of Safety Pharmacology

Michael K. Pugsley,Michael J Curtis
Principles of Safety Pharmacology Book PDF

Author : Michael K. Pugsley,Michael J Curtis
Publisher : Springer
Page : 481 pages
File Size : 55,9 Mb
Release : 2015-06-19
Category : Medical
ISBN : 9783662469439

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Principles of Safety Pharmacology by Michael K. Pugsley,Michael J Curtis Pdf

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Global New Drug Development

Jan A. Rosier,Mark A. Martens,Josse R. Thomas
Global New Drug Development Book PDF

Author : Jan A. Rosier,Mark A. Martens,Josse R. Thomas
Publisher : John Wiley & Sons
Page : 424 pages
File Size : 49,9 Mb
Release : 2014-07-03
Category : Medical
ISBN : 9781118414859

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Global New Drug Development by Jan A. Rosier,Mark A. Martens,Josse R. Thomas Pdf

The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely." —Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)

Rare Diseases and Orphan Products

Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Rare Diseases and Orphan Products Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 49,7 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060

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Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Principles and Practice of Pharmaceutical Medicine

Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Principles and Practice of Pharmaceutical Medicine Book PDF

Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Page : 780 pages
File Size : 48,9 Mb
Release : 2007-04-30
Category : Medical
ISBN : 0470093145

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Principles and Practice of Pharmaceutical Medicine by Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier Pdf

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Clinical Trials Handbook

Shayne Cox Gad
Clinical Trials Handbook Book PDF

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1247 pages
File Size : 49,8 Mb
Release : 2009-06-17
Category : Science
ISBN : 9780470466353

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Clinical Trials Handbook by Shayne Cox Gad Pdf

Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.