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Uses of Generative AI in Pharmacovigilance

Featured News / Posts

Signal Analytics Technology in Pharmacovigilance: Enhancing Drug Safety Monitoring

Pharmacovigilance plays a crucial role in ensuring public safety by monitoring, … [Read More...] about Signal Analytics Technology in Pharmacovigilance: Enhancing Drug Safety Monitoring

8 Common FDA Applications for Drugs & Biologics

The U.S. Food and Drug Administration (FDA) has several types of applications … [Read More...] about 8 Common FDA Applications for Drugs & Biologics

Key IND Enabling Studies: Navigating Preclinical Development Regulations

Investigational New Drug (IND) applications represent a critical stage in the … [Read More...] about Key IND Enabling Studies: Navigating Preclinical Development Regulations

Pharmacokinetics and Pharmacodynamics (PKPD): Fundamentals in Drug Development and Therapeutic Effectiveness

Pharmacokinetics and pharmacodynamics are two fundamental pillars in the field … [Read More...] about Pharmacokinetics and Pharmacodynamics (PKPD): Fundamentals in Drug Development and Therapeutic Effectiveness

Current Regulations Regarding Reference Safety Information (RSI): Key Aspects and Updates

Regulatory authorities in the pharmaceutical industry have established standards … [Read More...] about Current Regulations Regarding Reference Safety Information (RSI): Key Aspects and Updates

Methods of Statistical Signal Detection in Patient Safety and Pharmacovigilance: Key Techniques and Approaches

In the realm of patient safety and pharmacovigilance, statistical signal … [Read More...] about Methods of Statistical Signal Detection in Patient Safety and Pharmacovigilance: Key Techniques and Approaches

Pharmacovigilance Signal Detection Software: Enhancing Drug Safety and Monitoring

Pharmacovigilance signal detection software plays a crucial role in … [Read More...] about Pharmacovigilance Signal Detection Software: Enhancing Drug Safety and Monitoring

What is a PBRER? Understanding Periodic Benefit-Risk Evaluation Reports

A Periodic Benefit-Risk Evaluation Report (PBRER) serves as a structured … [Read More...] about What is a PBRER? Understanding Periodic Benefit-Risk Evaluation Reports

Drug Safety vs Pharmacovigilance: Exploring Conceptual Differences

Drug safety and pharmacovigilance are crucial aspects of public … [Read More...] about Drug Safety vs Pharmacovigilance: Exploring Conceptual Differences

Which Sections of a DSUR Must Present Safety and Pharmacovigilance Quantitative Data: Key Components Explained

he Development Safety Update Report (DSUR) is a crucial document that serves as … [Read More...] about Which Sections of a DSUR Must Present Safety and Pharmacovigilance Quantitative Data: Key Components Explained

What is a DSUR (Development Safety Update Report)? An Essential Guide for Clinical Research
What is a BLA (Biologics License Application)? Essential Guide for Professionals
What is a PADER? – Periodic Adverse Drug Experience Report Explained

ICH News

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From Nature journal

Pharmacokinetic analysis of selective TRPV2 inhibitor SET2 in rats
A comprehensive study on drug-related Raynaud’s phenomenon based on the FDA adverse event reporting system
A disproportionality analysis of adverse events caused by pexidartinib from the FDA adverse event reporting system
Mystery of tamoxifen-associated uterine cancer uncovered
A real-world safety signal detection study of ondansetron based on FAERS reports from 2014 to 2024

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