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A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
  • Author : Ali S. Faqi
  • Publsiher : Academic Press
  • Release : 16 November 2012
  • ISBN : 0123878152
  • Pages : 885 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKA Comprehensive Guide to Toxicology in Preclinical Drug Development

Summary:
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


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


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


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


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


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 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, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts


Flavonoid Pharmacokinetics

Flavonoid Pharmacokinetics
  • Author : Neal M. Davies,Jaime A. Yáñez
  • Publisher : John Wiley & Sons
  • Release : 05 November 2012
GET THIS BOOKFlavonoid Pharmacokinetics

SETS FORTH A FRAMEWORK FOR THE ANALYSIS AND STUDY OF FLAVONOIDS More and more dietary supplements contain flavonoids. These products are typically viewed as food rather than drug products by regulatory agencies and therefore not subjected to rigorous clinical trials before they are marketed to the general public. As a result, the use of flavonoid-containing supplements presents a potential public health risk. From discovery to therapeutic application, this book is a comprehensive guide to both achiral and chiral flavonoids, enabling


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


ADME-Enabling Technologies in Drug Design and Development

ADME-Enabling Technologies in Drug Design and Development
  • Author : Donglu Zhang,Sekhar Surapaneni
  • Publisher : John Wiley & Sons
  • Release : 13 April 2012
GET THIS BOOKADME-Enabling Technologies in Drug Design and Development

A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the developmentof analytical techniques such as mass spectrometry and molecularbiology tools, resulting in important advances in drug discovery,particularly in the area of absorption, distribution, metabolism,and excretion (ADME). ADME-Enabling Technologies in Drug Design and Developmentfocuses on the current state of the art in the field, presenting acomprehensive review of the latest tools for generating ADME datain drug discovery. It examines the broadest


Drug Metabolism and Pharmacokinetics Quick Guide

Drug Metabolism and Pharmacokinetics Quick Guide
  • Author : Siamak Cyrus Khojasteh,Harvey Wong,Cornelis E.C.A. Hop
  • Publisher : Springer Science & Business Media
  • Release : 07 April 2011
GET THIS BOOKDrug Metabolism and Pharmacokinetics Quick Guide

Drug Metabolism and Pharmacokinetics Quick Guide covers a number of aspects of drug assessment at drug discovery and development stages, topics such as pharmacokinetics, absorption, metabolism, enzyme kinetics, drug transporters, drug interactions, drug-like properties, assays and in silico calculations. It covers key concepts, with useful tables on physiological parameters (eg. blood flow to organs in x-species, expression and localization of enzymes and transporters), chemical structure, nomenclature, and moieties leading to bioactivation (with examples). Overall it includes a number of key


Oligonucleotide-Based Drugs and Therapeutics

Oligonucleotide-Based Drugs and Therapeutics
  • Author : Nicolay Ferrari,Rosanne Seguin
  • Publisher : John Wiley & Sons
  • Release : 31 July 2018
GET THIS BOOKOligonucleotide-Based Drugs and Therapeutics

A comprehensive review of contemporary antisense oligonucleotides drugs and therapeutic principles, methods, applications, and research Oligonucleotide-based drugs, in particular antisense oligonucleotides, are part of a growing number of pharmaceutical and biotech programs progressing to treat a wide range of indications including cancer, cardiovascular, neurodegenerative, neuromuscular, and respiratory diseases, as well as other severe and rare diseases. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide covering all key aspects of this increasingly popular


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.


Genomics in Drug Discovery and Development

Genomics in Drug Discovery and Development
  • Author : Dimitri Semizarov,Eric Blomme
  • Publisher : John Wiley & Sons
  • Release : 03 November 2008
GET THIS BOOKGenomics in Drug Discovery and Development

Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and