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Comprehensive Guide to Toxicology in Preclinical Drug Development

ISBN-10: 0123878152

ISBN-13: 9780123878151

Edition: 2013

Authors: Ali S. Faqi

List price: $199.95
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Description:

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. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guidelines for safety evaluation and present both traditional and nontraditional toxicology models. By incorporating the latest research in this area and featuring real-life examples and scenarios, this reference is a complete and practical 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.    Incorporates real-life case studies and examples and offers readers a practical resource that outlines day-to-day activities and experiences in preclinical toxicology.
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Book details

List price: $199.95
Copyright year: 2013
Publisher: Elsevier Science & Technology Books
Publication date: 12/10/2012
Binding: Hardcover
Pages: 1024
Size: 8.75" wide x 11.25" long x 2.00" tall
Weight: 6.314
Language: English

MPI Research, Mattawan, MI USA

Introduction
Discovery ADME
Pharmacokinetics/Toxicokinetics
Development of Preclinical Formulations for Toxicology Studies
Acute, sub-acute and chronic toxicity testing
Safety Pharmacology
Genetic Toxicology
Clinical Pathology
Best Practice in Toxicologic Pathology
Molecular pathology in preclinical Toxicology
Infusion Toxicology
The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials
Developmental & Reproductive Toxicology
Immunotoxicology
Toxicity Studies to Support Clinical Trials in Pediatric Population
Photoxicity
Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay
Carcinogenicity Evaluations using Genetically Engineered Animals
Current Strategies for Abuse Liability Assessment of New Chemical Entities
Impact of product attributes on preclinical safety evaluation
Preclinical Development of Monoclonal Antibodies
Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)
Preclinical Development of Oncology Drugs
Safety Evaluation of Ocular Drugs
Preclinical toxicology of vaccines
Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics
Preclinical Development of Botanical Drugs
Regulatory Toxicology
Chinese Drug Regulations
Biostatistics for Toxicologists
Study Director and Preclinical Study Monitoring Role
Use of Imaging for Preclinical Evaluation
Predictive Toxicology
Metabolics in Toxicology
Toxicogenomics in Drug Development
Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm to Toxicology in Preclinical Drug Development