Comprehensive Guide to Drug Safety Evaluation

Stay ahead of the curve in the development of drugs and therapeutics with the fourth edition of Drug Safety Evaluation, a practical guide that presents a roadmap for safety assessment as an integral part of the drug development process.

What You’ll Learn

This all-inclusive guide covers the scientific and philosophical bases for evaluating specific concerns, including carcinogenicity, developmental toxicity, and more. You’ll also learn about the latest approaches to hazard evaluation, including problem-solving strategies and solutions.

Key Topics Covered

• The drug development process and global pharmaceutical marketplace
• Regulation of human pharmaceutical safety
• Electronic records, reporting, and submission in safety evaluation
• Screens and hazard assessment in drug safety evaluation
• Mechanisms and endpoints of drug toxicity
• Pilot toxicity testing in drug safety evaluation
• Repeat dose toxicity and genotoxicity
• QSAR tools for drug safety and toxicogenomics
• Non-rodent animal studies and developmental and reproductive toxicity testing

New Chapters and Revisions

This fourth edition includes four new chapters, addressing the latest changes in regulatory requirements, pharmaceutical development, technology, and the impact of COVID-19 on our society and science.

Target Audience

This guide is written specifically for professionals in the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, who need to understand how to evaluate the safety of drugs and biologics.

Appendix and CROs

The book includes an appendix that provides an up-to-date guide to Contract Research Organizations (CROs) for conducting studies, as well as other valuable resources for safety evaluation and problem-solving.

Publication Details

Drug Safety Evaluation is published by Wiley and available in English, with ISBN 9781119755852 and ISBN 9781119755869.

Get the most out of your drug development process with this comprehensive guide. Order your copy today to stay ahead of the curve in drug safety evaluation.

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