Drug Safety Evaluation, 4th Edition

Drug Safety Evaluation, 4th Edition

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File Size : 16.9 MB

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Drug Safety Evaluation, 4th Edition

By Shayne Cox Gad, Dexter W. Sullivan Jr.

Drug Safety Evaluation, written by Shayne Cox Gad and Dexter W. Sullivan Jr., is a comprehensive and practical guide that serves as a roadmap for safety assessment in the development of drugs and therapeutics. This fourth edition of the book aims to provide valuable insights and guidance to those responsible for ensuring the safety of drugs and biologics, including healthcare providers, individuals involved in the manufacturing of medicinal products, and anyone seeking to understand how the safety of these products is evaluated.

With the rapid advancements in technology and the evolving regulatory landscape, this edition has undergone extensive revisions and includes four new chapters to address these changes. The book covers a wide range of topics related to drug safety evaluation, including the drug development process, global pharmaceutical marketplace, regulation of human pharmaceutical safety, sources of information for study and program design, electronic records and reporting, mechanisms and endpoints of drug toxicity, genotoxicity, QSAR tools for drug safety, and many more.

One of the strengths of Drug Safety Evaluation is its practical approach, providing not only theoretical explanations but also real-world examples, challenges, and solutions encountered in safety evaluation. This makes it a valuable resource not only for scientists and professionals in the pharmaceutical and biotechnology industries but also for consultants, academics, and researchers.

The authors emphasize the significance of understanding the scientific and philosophical bases for evaluating specific concerns such as carcinogenicity and developmental toxicity. By providing a deep understanding of these concepts, the book enables readers to approach new challenges confidently and make informed decisions.

Moreover, Drug Safety Evaluation acknowledges the impact of the COVID-19 pandemic on society and science. The authors discuss the implications of the pandemic on drug development, regulatory requirements, and safety evaluation. This inclusion ensures that the book remains relevant in the rapidly evolving landscape of drug development.

In terms of structure, the book is well-organized and easily navigable. Each chapter focuses on a specific aspect of safety evaluation, providing detailed explanations, case studies, and practical tips. The inclusion of an appendix that lists up-to-date Contract Research Organizations (CROs) for conducting studies further enhances the book’s usefulness as a comprehensive guide.

Readers will appreciate the balanced approach that Drug Safety Evaluation takes between scientific rigor and practicality. The authors strike a perfect balance between providing in-depth scientific information and presenting it in a manner that is accessible and relatable. Even those with a limited background in pharmacology or toxicology will find the content both informative and easily comprehensible.

Furthermore, the inclusion of visuals, such as tables, figures, and charts, enhances the learning experience and aids in the understanding of complex concepts. The use of these visuals is particularly helpful when discussing mechanisms of drug toxicity or presenting data from toxicological studies.

The authors also make a conscious effort to address the global nature of the pharmaceutical industry. They discuss not only the regulatory requirements in the United States but also provide insights into global practices and considerations. This global perspective makes the book applicable to a broad audience, regardless of geographical location.

Overall, Drug Safety Evaluation is an invaluable resource for anyone involved in the drug development process. Whether you are a seasoned professional or a novice in the field, this book equips you with the knowledge and tools necessary to evaluate the safety of drugs and therapeutics rigorously. By providing practical guidance, real-world examples, and addressing the latest regulatory and technological developments, the authors ensure that readers are well-prepared to navigate the ever-changing landscape of drug safety evaluation.

If you are looking to enhance your understanding of drug safety evaluation or seeking a comprehensive guide to navigate the challenges in this field, Drug Safety Evaluation is a must-read. Order your copy today and embark on an enlightening journey into the world of drug safety assessment and evaluation.

Product Details

  • 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 which provides an up to date guide to CROs for conducting studies
  • Publisher ‏ : ‎ Wiley; 4th edition (January 5, 2023)
  • Language ‏ : ‎ English
  • Hardcover ‏ : ‎ 992 pages
  • ISBN-10 ‏ : ‎ 1119755859
  • ISBN-13 ‏ : ‎ 978-1119755852

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