Tag: pharmacovigilance
Drug Safety Signals and Clinical Trials: How Hidden Risks Emerge After Approval
Drug safety signals reveal hidden risks that clinical trials miss. Learn how real-world data, statistical tools, and human expertise uncover dangers after a drug hits the market - and why this process is critical for public health.
Dechallenge and Rechallenge in Drug Side Effects: What These Tests Mean
Dechallenge and rechallenge are key methods used to determine if a drug caused a side effect. Stopping the drug to see if symptoms improve is dechallenge. Restarting it to see if the reaction returns is rechallenge - the strongest proof of causality.
How to Access FDA Adverse Event Databases for Safety Monitoring
Learn how to access and use the FDA's FAERS database for drug safety monitoring. Discover tools, limitations, and real-world ways to spot potential side effects from public adverse event reports.