Practical Aspects Of Signal Detection In Pharmacovigilance
Download Practical Aspects Of Signal Detection In Pharmacovigilance PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Practical Aspects Of Signal Detection In Pharmacovigilance book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages.
Practical Aspects of Signal Detection in Pharmacovigilance
Author: Council for International Organizations of Medical Sciences (CIOMS)
language: en
Publisher: Cioms
Release Date: 2010
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Signal Analysis in Pharmacovigilance
This book provides detailed concepts and information on principles and processes of signal analysis in pharmacovigilance along with case studies. It covers the fundamental concepts and principles of pharmacovigilance, emphasizing the need for robust signal detection and analysis methods. The book reviews the diverse array of databases and tools employed for signal detection, including electronic health records (EHRs), social media mining, claims data, and distributed data networks. In turn, the book discusses the application of molecular dynamics, molecular docking, and the use of the FDA Adverse Event Reporting System (FAERS) database in signal analysis. Toward the end, the book explores the identification, validation, and assessment of signals associated with vaccines. This book is useful for graduate, post-graduate students of pharmaceutical sciences, and scientists in pharmacology research and drug development.
Practical Aspects of Signal Detection in Pharmacovigilance
Author: Council for International Organizations of Medical Sciences (CIOMS)
language: en
Publisher: Cioms
Release Date: 2010
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.