Comprehensive Guide to Drug Safety Evaluation: Ensuring Safety in Pharmaceutical Development

Authored by Shayne Cox Gad and Dexter W. Sullivan Jr., this fourth edition of Drug Safety Evaluation presents a practical roadmap for safety assessment, an integral part of the development of drugs and therapeutics.

About the Book

This comprehensive guide is designed for those responsible for ensuring the safety of drugs and biologics, including patients, healthcare providers, manufacturers of medicinal products, and individuals involved in pharmaceutical development. It provides an all-inclusive practical approach to evaluating the safety of medicinal products and guiding valuable candidates to market.

Key Features

• Individual chapters addressing specific approaches to evaluating hazards, including problems encountered and their solutions
• Coverage of the scientific and philosophical bases for evaluating specific concerns, such as carcinogenicity and developmental toxicity
• Extensive revisions to every chapter and the addition of four new chapters to address changes in regulatory requirements, pharmaceutical development, technology, and the impact of Covid-19 on society and science

Sample Topics Covered

• The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety
• Sources of information for consideration in study and program design and in safety evaluation
• Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens
• Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity
• Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing
• An appendix providing an up-to-date guide to Contract Research Organizations (CROs) for conducting studies

About the Authors

Shayne Cox Gad and Dexter W. Sullivan Jr. bring their expertise in the pharmaceutical and biotechnology industries to provide a utilitarian yet scientifically valid path to addressing the everyday challenges of safety evaluation and problem-solving in drug discovery and development.

Published by Wiley, this fourth edition is available in English, featuring 992 pages in hardcover format, with an ISBN-10 of 1119755859 and ISBN-13 of 978-1119755852.