A 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 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

Produk Detail:

  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Pages : 986 pages
  • ISBN : 0128036214
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKA Comprehensive Guide to Toxicology in Nonclinical Drug Development

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 : 03 November 2016
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 : 16 November 2012
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 : 13 March 2015
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

Pediatric Non-Clinical Drug Testing

Pediatric Non-Clinical Drug Testing
  • Author : Alan M. Hoberman,Elise M. Lewis
  • Publisher : John Wiley & Sons
  • Release : 28 December 2011
GET THIS BOOKPediatric Non-Clinical Drug Testing

This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical

Pathology for Toxicologists

Pathology for Toxicologists
  • Author : Elizabeth McInnes
  • Publisher : John Wiley & Sons
  • Release : 16 March 2017
GET THIS BOOKPathology for Toxicologists

Non-pathologists, such as toxicologists and study personnel, can find it difficult to understand the data they receive from pathologists. Toxicological pathologists write long, detailed and highly technical reports. Study personnel are under daily pressure to decide whether lesions described in pathology reports are treatment-related and thus important to the pharmaceutical company or whether the lesions are background changes and thus of little significance. Written by experienced toxicological pathologists, Pathology for Toxicologists: Principles and Practices of Laboratory Animal Pathology for Study

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release : 06 February 2014
GET THIS BOOKImproving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective

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 F. Weinbauer
  • Publisher : Academic Press
  • Release : 12 March 2015
GET THIS BOOKThe Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

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.

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 : 30 April 2007
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

Drug Safety Evaluation

Drug Safety Evaluation
  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release : 18 November 2016
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

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
  • Publisher : National Academies Press
  • Release : 03 April 2011
GET THIS BOOKRare Diseases and Orphan Products

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.

Development and Approval of Combination Products

Development and Approval of Combination Products
  • Author : Evan B. Siegel
  • Publisher : John Wiley & Sons
  • Release : 09 June 2008
GET THIS BOOKDevelopment and Approval of Combination Products

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

Preclinical Development Handbook

Preclinical Development Handbook
  • Author : Shayne Cox Gad
  • Publisher : John Wiley & Sons
  • Release : 21 March 2008
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.

Principles of Safety Pharmacology

Principles of Safety Pharmacology
  • Author : Michael K. Pugsley,Michael J Curtis
  • Publisher : Springer
  • Release : 19 June 2015
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

Antibody-Drug Conjugates

Antibody-Drug Conjugates
  • Author : Kenneth J. Olivier, Jr.,Sara A. Hurvitz
  • Publisher : John Wiley & Sons
  • Release : 14 November 2016
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

Histological Techniques

Histological Techniques
  • Author : Robert Maynard,Noel Downes,Brenda Finney
  • Publisher : Royal Society of Chemistry
  • Release : 09 November 2015
GET THIS BOOKHistological Techniques

Histological techniques form the basis of many areas of research, yet they can often be poorly understood. Aimed at postgraduate students and those at an early stage of their career, this title provides a detailed and comprehensive introduction to histological techniques. With detailed images and slides, this book provides a unique overview of the area while providing the reader with a guide to how to use and incorporate histological techniques within their own research. Written by experts working within the