A Comprehensive Guide to Toxicology in Nonclinical Drug Development

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  • Publisher : Academic Press
  • Release : 03 November 2016
  • ISBN : 9780128036211
  • Page : 986 pages
  • Rating : 4.5/5 from 103 voters

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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

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2016-11-03
  • ISBN : 9780128036211
GET THIS BOOKA Comprehensive Guide to Toxicology in Nonclinical Drug Development

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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2012-10-18
  • ISBN : 9780123878168
GET THIS BOOKA Comprehensive Guide to Toxicology in Preclinical Drug Development

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

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
  • Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
  • Publisher : Academic Press
  • Release Date : 2015-03-13
  • ISBN : 9780124171466
GET THIS BOOKThe Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

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

Drug Safety Evaluation

Drug Safety Evaluation
  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release Date : 2016-11-18
  • ISBN : 9781119097402
GET THIS BOOKDrug Safety Evaluation

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

Drug Discovery Toxicology

Drug Discovery Toxicology
  • Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
  • Publisher : John Wiley & Sons
  • Release Date : 2016-03-22
  • ISBN : 9781119053392
GET THIS BOOKDrug Discovery Toxicology

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

Principles of Safety Pharmacology

Principles of Safety Pharmacology
  • Author : Michael K. Pugsley,Michael J Curtis
  • Publisher : Springer
  • Release Date : 2015-06-19
  • ISBN : 9783662469439
GET THIS BOOKPrinciples of Safety Pharmacology

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

Developmental and Reproductive Toxicology

Developmental and Reproductive Toxicology
  • Author : Ali S. Faqi
  • Publisher : Humana Press
  • Release Date : 2017-08-18
  • ISBN : 1493972065
GET THIS BOOKDevelopmental and Reproductive Toxicology

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

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine
  • Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
  • Publisher : John Wiley & Sons
  • Release Date : 2007-04-30
  • ISBN : 0470093145
GET THIS BOOKPrinciples and Practice of Pharmaceutical Medicine

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

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
  • Author : Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
  • Publisher : CRC Press
  • Release Date : 2020-12-23
  • ISBN : 9780429651137
GET THIS BOOKCurrent Topics in Nonclinical Drug Development

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.

Essentials of Laboratory Animal Science: Principles and Practices

Essentials of Laboratory Animal Science: Principles and Practices
  • Author : P. Nagarajan,Ramachandra Gudde,Ramesh Srinivasan
  • Publisher : Springer Nature
  • Release Date : 2021-07-23
  • ISBN : 9789811609879
GET THIS BOOKEssentials of Laboratory Animal Science: Principles and Practices

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

Preclinical Development Handbook

Preclinical Development Handbook
  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release Date : 2008-03-21
  • ISBN : 0470249048
GET THIS BOOKPreclinical Development Handbook

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.

Drug Safety Evaluation

Drug Safety Evaluation
  • Author : Shayne Cox Gad,Dexter W. Sullivan, Jr.
  • Publisher : John Wiley & Sons
  • Release Date : 2023-01-05
  • ISBN : 9781119755876
GET THIS BOOKDrug Safety Evaluation

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is

Botanical Drug Products

Botanical Drug Products
  • Author : Jayant N. Lokhande,Yashwant V. Pathak
  • Publisher : CRC Press
  • Release Date : 2018-12-03
  • ISBN : 9781315352282
GET THIS BOOKBotanical Drug Products

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
  • Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
  • Publisher : CRC Press
  • Release Date : 2019-12-13
  • ISBN : 9781351625135
GET THIS BOOKDrug Discovery and Development, Third Edition

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

Antibody-Drug Conjugates

Antibody-Drug Conjugates
  • Author : Kenneth J. Olivier, Jr.,Sara A. Hurvitz
  • Publisher : John Wiley & Sons
  • Release Date : 2016-11-14
  • ISBN : 9781119060802
GET THIS BOOKAntibody-Drug Conjugates

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