Pharmacovigilance - 2nd Edition by Thao Doan & Fabio Lievano & Linda Scarazzini & Charles Schubert & Barbara Hendrickson (Paperback)

Book Synopsis

Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

• Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologies
• Provides up-to-date coverage of hot topics in the field, including pharmacodynamic and safety precision medicine, immunogenicity, vaccine hesitancy and safety, genetic toxicology, and adverse events
• Contains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and more
• Offers new and expanded coverage of pharmacovigilance in early pre-clinical drug development through post-marketing surveillance, as well as a blueprint for training future pharmacovigilance professionals
• Includes real-world case studies to ensure content is relevant and applicable to everyday practice
• Discusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communication
• An eBook version is included with purchase. The eBook allows you to access all of the text, figures and references, with the ability to search, customize your content, make notes and highlights, and have content read aloud. Additional digital ancillary content may publish up to 6 weeks following the publication date

Review Quotes

"The text serves to provide a comprehensive overview of preclinical drug development and the regulatory process while intertwining ongoing monitoring for drug-related adverse events.... The breadth of expertise and experience of the authors offers significant insights and makes this book an appropriate text for training professionals within the pharmacovigilance field.... The writing is consistent from chapter to chapter despite the variety of authors writing each section, ... uses visual images to demonstrate concepts for easier comprehensibility and adds summary boxes within each chapter to provide a brief overview. The illustrations and diagrams are clear, easy to read, and intuitively placed throughout each chapter to prevent overwhelming readers.... provides a great degree of detail relating to all aspects of pharmacovigilance, covering pre-clinical safety management, signal and risk management, and first-in-human trials while also addressing special populations and integration information technology.... Overall, for individuals training within pharmacovigilance or interested in learning more about a field, this book is strongly recommended as it provides an excellent, comprehensive structured review of the field." Review by Vasyl Zbyrak, PharmD (Temple University School of Pharmacy), (c)Doody's Review Service, 2025.