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Author: Eugène Paul Puijenbroek
Publisher:
ISBN: 9789039327968
Category :
Languages : en
Pages : 197
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Book Description
Author: Eugène Paul Puijenbroek
Publisher:
ISBN: 9789039327968
Category :
Languages : en
Pages : 197
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Book Description
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0
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Book Description
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.
Author: Michelle P. A. Perry
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 1118820142
Category : Medical
Languages : en
Pages : 878
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Book Description
Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Author: William Wang
Publisher: CRC Press
ISBN: 0429949995
Category : Mathematics
Languages : en
Pages : 347
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Book Description
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Author: Qi Jiang
Publisher: CRC Press
ISBN: 1466555459
Category : Mathematics
Languages : en
Pages : 386
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Book Description
State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
Author: Andrew Bate
Publisher: Humana
ISBN: 9781493988167
Category : Medical
Languages : en
Pages : 0
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Book Description
This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.
Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 0470671041
Category : Medical
Languages : en
Pages : 878
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Book Description
Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Author: Megna Bali
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Signal detection is a critical part of the overall risk management process and has evolved quite significantly over the last few years. Various signal detection methods have been developed and applied to probe the adverse event databases to identify identification of disproportionality in the particular drug adverse event pairs. It is quintessential to accurately track and manage signals keeping in view the growing importance of stringent regulations across the globe. Signals in pharmacovigilance have a variety of sources. Pharmacovigilance may not rely upon one single method, but needs a strategy of complementary activities. Statistical data mining approaches have been developed and applied in the field of drug safety surveillance, adding to the toolkit of pharmacovigilance professionals. The study revealed that no statistical methods or algorithms would replace the importance of medical and scientific judgment of trained pharmacovigilance professionals. There is no single right approach that would be optimal for all medicinal products in all situations. It is necessary to find an optimum balance, not just with regard to the use of statistics (Frequentist vs Bayesian) but also among thresholds used for signal detection. A number of investigations explored whether differences exist between Frequentist and Bayesian approaches and found that PRR is more sensitive than MGPS, although the estimation from the MGPS is believed to be more robust when the number of reports is small. Further development of statistical methods and technological solutions to analyse large amounts of data to detect signals for potential safety issues, while minimizing noise, would enhance the efficiency and effectiveness of pharmacovigilance activities. Overall, data derived from DMAs should be considered with caution and guided by appropriate clinical evaluation. This clinical perspective should always be considered to support really appropriate drug use, balancing drug effectiveness, safety and, above all, actual patientsu2019 needs. The statistical procedures underlying contemporary data mining cannot offset the limitations of spontaneous reporting system data. Qualitative medical review and assessment are indispensable to guide the quantitative analysis and evaluation. As the amount of information increases, codifying human expertsu2019 tacit reasoning and consistent application of sound pharmacovigilance logic become more and more important in supporting proactive and scalable safety surveillance.
Author: Andrew Bate
Publisher:
ISBN: 9781493988181
Category :
Languages : en
Pages : 275
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Book Description
