Drug Safety Evaluation (4th Edition) – PDF

Drug Safety Evaluation, 4th Edition (PDF) – Pharmaceutical Development Series

This Drug Safety Evaluation, Fourth Edition serves as a comprehensive and practical guide for safety assessment in the development of drugs and therapeutics. It aims to provide all-inclusive practical guidance to those responsible for ensuring the safety of drugs and biologics, including patients, healthcare providers, manufacturers of medicinal products, and others involved in the evaluation process.

The book covers specific approaches to evaluating hazards, addressing problems encountered and offering solutions. It also discusses the scientific and philosophical bases for evaluating specific concerns such as development toxicity and carcinogenicity. The updated edition accounts for changes in regulatory requirements, pharmaceutical development, technology, and the impact of Covid on society and science.

Key topics covered in the book include:

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

The book is primarily intended for professionals in the pharmaceutical and biotechnology industries, including scientists, consultants, and academics. It offers a utilitarian yet scientifically valid approach to the challenges of safety evaluation and problem-solving in drug discovery and development.

ISBN: 978-1119755852

NOTE: This sale only includes the ebook Drug Safety Evaluation, 4th Edition (Pharmaceutical Development Series) in PDF format. No access codes are included.