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Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)
Surveys are commonly used to assess effectiveness of FDA-required risk evaluation and mitigation strategies (REMS) for dru...
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
Biosimilar CT-P13 was approved with limited data from clinical trials compared to the originator infliximab in biologic-na...
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
During the signal detection process, statistical methods are used to identify drug–event combinations (DECs) which a...
Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach
Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach
In recent years, the volume of data collected by spontaneous reporting systems (SRS) ...
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021
In studies evaluating the effectiveness of additional risk minimisation measures (aRMMs), the need for speed must be prope...
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective
There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, ...
Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea
Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea
Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructiv...
Authors’ Reply to Cappello et al. Comment on: “Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
Authors’ Reply to Cappello et al. Comment on: “Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
Funding No specific funding supported this research. ...
Comment on: “Deliberate Self-Poisoning: Real-Time Characterisation of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
Comment on: “Deliberate Self-Poisoning: Real-Time Characterisation of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
Conflict of interest All the authors have no conflicts of interest ...
Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel
Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel
Trastuzumab deruxtecan (T-DXd)—an antibody–drug conjugate targeting the human epidermal growth factor receptor...
Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study
Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study
Dual diethylcarbamazine and albendazole (DA) therapy is the standard mass drug administration (MDA) regimen for lymphatic ...
Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
In February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 201...
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
Previous pre-clinical and pharmacovigilance disproportionality analyses highlighted a safety signal of cutaneous ulcer wit...
Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility
Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility
Spontaneous reporting of adverse events has increased steadily over the past decades, and although this trend has contribu...
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associate...
Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
Janus kinase inhibitors (JAKi) have enormous appeal as immune-modulating therapies across many chronic inflammatory diseas...
Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy in women with hormone receptor-positive, h...
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
Disproportionality analysis is traditionally used in spontaneous reporting systems to generate working hypotheses about po...
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study
The ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) prepar...
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
Pharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing su...
Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians
Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians
Immune checkpoint inhibitors (ICIs) have revolutionized the treatment and care of patients with cancer owing to unique fea...
Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012–2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate
Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012–2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate
Adverse drug reactions (ADRs) contribute to morbidity, and serious ADRs may cause hospitalisation and death. This study ch...
Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency
Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency
Machine learning (ML) systems are widely used for automatic entity recognition in pharmacovigilance. Publicly available da...
Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques
Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques
Concerns have been raised over the quality of drug safety information, particularly data completeness, collected through s...
Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
Vaccine safety surveillance commonly includes a serial testing approach with a sensitive method for ‘signal generati...
Future of ChatGPT in Pharmacovigilance
Future of ChatGPT in Pharmacovigilance
Developed by OpenAI, ChatGPT is a sophisticated large language model (LLM) capable of...
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
Because of their broad-spectrum bactericidal activity, amoxicillin (AMX) and third-generation cephalosporins (TGC) are wid...
Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study
Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study
Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention prog...
Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data
Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data
Time- and resource-demanding activities related to processing individual case safety reports (ICSRs) include manual proced...
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
Underreporting is a major limitation of the voluntary reporting system of adverse drug reactions (ADRs). A 2009 systematic...
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