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

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  • 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

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
  • Author : Alberto Lodola,Jeanne Stadler
  • Publisher : John Wiley & Sons
  • Release : 31 March 2011
GET THIS BOOKPharmaceutical Toxicology in Practice

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

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

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 : 01 May 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

A Practical Guide to Drug Development in Academia

A Practical Guide to Drug Development in Academia
  • Author : Daria Mochly-Rosen,Kevin Grimes
  • Publisher : Springer Science & Business Media
  • Release : 08 July 2014
GET THIS BOOKA Practical Guide to Drug Development in Academia

"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help

Drug Discovery Toxicology

Drug Discovery Toxicology
  • Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
  • Publisher : John Wiley & Sons
  • Release : 22 March 2016
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

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals
  • Author : Joy A. Cavagnaro
  • Publisher : John Wiley & Sons
  • Release : 07 March 2013
GET THIS BOOKPreclinical Safety Evaluation of Biopharmaceuticals

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe

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

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

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
  • Author : Lisa Plitnick,Danuta Herzyk
  • Publisher : Academic Press
  • Release : 27 June 2013
GET THIS BOOKNonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and

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.