Investigating the Safety Profile of Fast‐Track <scp>COVID</scp>‐19 Drugs Using the <scp>FDA</scp> Adverse Event Reporting System Database: A Comparative Observational Study

We identified potential ADRs associated with COVID-19 drugs and provided insights into their real-world safety. This study demonstrated that real-world data and real-time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast-track approval, as exemplified by COVID-19 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real-time safety reviews.

Authors

Institutions

Publication Details

Journal
Pharmacoepidemiology and Drug Safety
Published
2024-11-01
DOI
https://doi.org/10.1002/pds.70043
Citations
2
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
0.70

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study

Kye Hwa Lee, Hyo Jung Kim, Jeong‐Hwa Yoon
2 citations
Pharmacoepidemiology and Drug Safety
Pharmacovigilance and Adverse Drug Reactions
0.70
article

Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study

Kye Hwa Lee, Hyo Jung Kim, Jeong‐Hwa Yoon
article en
2 citations

Abstract

We identified potential ADRs associated with COVID-19 drugs and provided insights into their real-world safety. This study demonstrated that real-world data and real-time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast-track approval, as exemplified by COVID-19 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real-time safety reviews.

Pharmacoepidemiology and Drug SafetyVol. 33(11)
Ulsan College (KR), Seoul National University (KR), Samsung (South Korea) (KR), Asan Medical Center (KR), Samsung Medical Center (KR), Sungkyunkwan University (KR)
National Research Foundation, Ministry of Education, Ministry of Health and Welfare, Korea Health Industry Development Institute, National Research Foundation of Korea
Good health and well-being
Openalex Percentile: Top 31%
Pharmacovigilance and Adverse Drug Reactions
0.70
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.

Investigating the Safety Profile of Fast‐Track <scp>COVID</scp>‐19 Drugs Using the <scp>FDA</scp> Adverse Event Reporting System Database: A Comparative Observational Study — Kye Hwa Lee, Hyo Jung Kim, et al. · Pharmacoepidemiology and Drug Safety (2024) | TGRS Research Map | TGRS