Guideline on the Use of Statistical Signal Detection Methods in the Eudravigilance Data Analysis System PDF Download
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Author: European Medicines Agency
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: European Medicines Agency
Publisher:
ISBN:
Category :
Languages : en
Pages :
Get Book Here
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: Anoop Kumar
Publisher: CRC Press
ISBN: 104011265X
Category : Medical
Languages : en
Pages : 301
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Book Description
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.
Author: Richard Kay
Publisher: John Wiley & Sons
ISBN: 1119867401
Category : Medical
Languages : en
Pages : 436
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Book Description
STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.
Author: Sabrina Nour
Publisher: Academic Press
ISBN: 012816381X
Category : Medical
Languages : en
Pages : 240
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Book Description
Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. - Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs - Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions - Offers case studies that illustrate real-life clinical situations - Discusses important concepts related to pharmacoepidemiology and pharmacovigilance
Author: Luciane Cruz Lopes
Publisher: Frontiers Media SA
ISBN: 2832531784
Category : Medical
Languages : en
Pages : 127
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Book Description
We are delighted to present the inaugural Frontiers in Pharmacology 'Women in Pharmacoepidemiology” series of article collections. This Research Topic is part of the Women in Pharmacology series. Other titles in the series are: Women in Obstetric and Pediatric Pharmacology: 2021 Women in Inflammation Pharmacology: 2021 Women in Integrative and Regenerative Pharmacology: 2021 Women in Pharmacology of Anti-Cancer Drugs: 2021 Women in Pharmacology of Infectious Diseases: 2021 Women in Drug Metabolism and Transport: 2021 Women in Cardiovascular and Smooth Muscle Pharmacology: 2021 Women in Inflammation Pharmacology: 2021 Women in Pharmacogenetics and Pharmacogenomics: 2021 Women in Neuropharmacology: 2021 Women in Drugs Outcomes Research and Policies: 2021 Women in Pharmacology of Ion Channels and Channelopathies: 2021 At present, according to UNESCO, less than 30% of researchers worldwide are women. Long-standing biases and gender stereotypes are discouraging girls and women away from science-related fields, and STEM research in particular. Science and gender equality are, however, essential to ensure sustainable development as highlighted by UNESCO. In order to change traditional mindsets, gender equality must be promoted, stereotypes defeated, and girls and women should be encouraged to pursue STEM careers. Therefore, Frontiers in Pharmacology is proud to offer this platform to promote the work of women scientists at different stages in their career, all over the world, and across all fields of Pharmacology. The work presented here highlights the diversity of research performed across the entire breadth of Pharmacoepidemiology research and presents advances in theory, experiment, and methodology with applications to compelling problems. For this Topic, we will be welcoming manuscripts covering: • Post-marketing observational studies on medications • Post-marketing studies in populations routinely excluded from clinical trials such as children, pregnant women, and elderlies • Observational studies on First Nations, racialized groups, and immigrant populations • Real-world evidence using large population-based administrative or clinical databases • Pharmacoepidemiologic real world evidence methodology • Novel pharmacoepidemiologic methodology such as artificial intelligence and deep learning models • Pharmacoeconomic studies
Author: Michael J. McGraw
Publisher: Pharmaceutical Press
ISBN: 0853697906
Category : Business & Economics
Languages : en
Pages : 273
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Book Description
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Author: Luciane Cruz Lopes
Publisher: Frontiers Media SA
ISBN: 2889742547
Category : Science
Languages : en
Pages : 248
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Book Description
Author: Elena Ramírez
Publisher: Frontiers Media SA
ISBN: 2832501915
Category : Science
Languages : en
Pages : 165
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Book Description
Author: J. Rick Turner
Publisher: John Wiley & Sons
ISBN: 0470411287
Category : Medical
Languages : en
Pages : 500
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Book Description
The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.
