Comprehensive Guide to Toxicology in Preclinical Drug Development

Name: Comprehensive Guide to Toxicology in Preclinical Drug Development
Availability: OutOfStock
ISBN: 9780123878151

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…

Book details

List price: $199.95
Copyright year: 2013
Publisher: Elsevier Science & Technology
Publication date: 12/10/2012
Binding: Hardcover
Pages: 1024
Size: 8.50" wide x 10.87" long x 2.00" tall
Weight: 5.940
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