Cargando…

Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance

The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for ‘real-world’ post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pa...

Descripción completa

Detalles Bibliográficos
Autores principales:	Layton, Deborah, Shakir, Saad A. W.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2015
Materias:	Review Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4328122/ https://www.ncbi.nlm.nih.gov/pubmed/25564333 http://dx.doi.org/10.1007/s40264-014-0260-x

Ejemplares similares

Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England
por: Osborne, Vicki, et al.
Publicado: (2020)

Indicators of Drug-Seeking Aberrant Behaviours: The Feasibility of Use in Observational Post-Marketing Cohort Studies for Risk Management
por: Layton, Deborah, et al.
Publicado: (2014)

Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort
por: Coughtrie, Abigail L, et al.
Publicado: (2017)

Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England
por: McNaughton, Rhian, et al.
Publicado: (2016)

Postmarketing pharmacovigilance: Remdesivir and cardiovascular events
por: Sullivan, John T.
Publicado: (2022)

Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes
por: Mackenzie, Isla S, et al.
Publicado: (2012)

Adverse events related to COVID-19 vaccines: the need to strengthen pharmacovigilance monitoring systems
por: Shrestha, Sunil, et al.
Publicado: (2021)

Target‐Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities
por: Schotland, Peter, et al.
Publicado: (2018)

International Society of Pharmacovigilance monitors vaccine safety
Publicado: (2022)

A New Era in Pharmacovigilance: Toward Real‐World Data and Digital Monitoring
por: Lavertu, Adam, et al.
Publicado: (2021)

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib
por: Yin, Yanchao, et al.
Publicado: (2022)

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax
por: Yang, Yang, et al.
Publicado: (2022)

A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib
por: Guo, Menglin, et al.
Publicado: (2022)

Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators
por: Garashi, Hamza, et al.
Publicado: (2022)

Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management
por: Osborne, Vicki, et al.
Publicado: (2020)

Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System
por: Zhao, Dehua, et al.
Publicado: (2023)

Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system
por: Shu, Yamin, et al.
Publicado: (2022)

Drug-induced fall risk in older patients: A pharmacovigilance study of FDA adverse event reporting system database
por: Zhou, Shuang, et al.
Publicado: (2022)

Pharmacovigilance
por: Griffin, J. P.
Publicado: (1992)

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology
por: Baldo, Paolo, et al.
Publicado: (2018)

Rhabdomyolysis Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
por: Teng, Chengwen, et al.
Publicado: (2019)

Delirium Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
por: Teng, Chengwen, et al.
Publicado: (2021)

Musculoskeletal adverse events induced by immune checkpoint inhibitors: a large-scale pharmacovigilance study
por: Liu, Hao, et al.
Publicado: (2023)

Major adverse cardiovascular events associated with testosterone treatment: a pharmacovigilance study of the FAERS database
por: Zhao, Hui, et al.
Publicado: (2023)

A Pharmacovigilance Study of Drug-Induced Glaucoma Utilizing the Japanese Adverse Event Reporting System
por: Kozaru, Mariko, et al.
Publicado: (2023)

Confidence in airway management proficiency: a mixed methods study of intensive care specialists in Australia and New Zealand
por: Shahab, Jordi, et al.
Publicado: (2023)

Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring
por: Jeetu, G, et al.
Publicado: (2010)

Status of adverse drug reaction monitoring and pharmacovigilance in selected countries
por: Yadav, Sachdev
Publicado: (2008)

Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance
por: Sahu, Ram Kumar, et al.
Publicado: (2014)

Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance
por: Sardella, Marco, et al.
Publicado: (2021)

Exploitation of semantic methods to cluster pharmacovigilance terms
por: Dupuch, Marie, et al.
Publicado: (2014)

Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis
por: Scicchitano, Francesca, et al.
Publicado: (2012)

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis
por: Giofrè, Chiara, et al.
Publicado: (2013)

Innovation in Pharmacovigilance: Use of Artificial Intelligence in Adverse Event Case Processing
por: Schmider, Juergen, et al.
Publicado: (2018)

Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview
por: Rodríguez, Sandra, et al.
Publicado: (2020)

Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS)
por: Ma, Pan, et al.
Publicado: (2022)

Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization’s Reporting? A Pharmacovigilance Study in Southern Italy
por: Scavone, Cristina, et al.
Publicado: (2018)

How to interact with medical terminologies? Formative usability evaluations comparing three approaches for supporting the use of MedDRA by pharmacovigilance specialists
por: Marcilly, Romaric, et al.
Publicado: (2020)

Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
por: Kan, Yusuke, et al.
Publicado: (2022)

Dictionary of pharmacovigilance /
por: Alghabban, Amer
Publicado: (2004)

Cannot write session to /tmp/vufind_sessions/sess_3khsf9m5ot97ku9s24i37rhvqk