دانلود کتاب فارماکوویژیلانس: یک رویکرد عملی
Pharmacovigilance: A Practical Approach 2nd Edition

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 pharmaco vigilance.

• 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

Review

Contents

۱ Does Regulation Drive Science or Does Science Drive Regulation?
۲ Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology
۳ Preclinical Safety Assessment: General and Genetic Toxicology
۴ Pharmacogenetics
۵ Safety Planning for First-in-Human Trials
۶ Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation
۷ Safety Monitoring in Clinical Trials
۸ Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials
۹ Product Aggregate Safety Assessment
۱۰ Data Monitoring Committees
۱۱ Methods of Signal Detection and Signal Management
۱۲ Causality Assessment
۱۳ Examples of Adverse Drug Reactions
۱۴ Internal Safety Advisory Groups
۱۵ Benefit–Risk Management
۱۶ Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry
۱۷ Real-World Pharmacoepidemiology Studies
۱۸ Pharmacovigilance in Pregnancy
۱۹ Pharmacovigilance in Pediatrics
۲۰ Pharmacovigilance in the Elderly
۲۱ Vaccine Pharmacovigilance
۲۲ Application of Human Factors and Health Literacy in Pharmacovigilance
۲۳ Medical Device Safety Oversight and Surveillance
۲۴ Information Technology in Pharmacovigilance: Current State and Future Directions
۲۵ The Future of Pharmacovigilance