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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

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Related Experiment Video

Updated: May 24, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Pharmacovigilance Assistant: An Agentic Workflow for Reproducible Drug Safety Summaries.

Xabier Calle1,2, Naroa Mendez1, Alba Garin-Muga1,2

  • 1Vicomtech Foundation, Basque Research and Technology Alliance, San Sebastian, Spain.

Studies in Health Technology and Informatics
|May 23, 2026
PubMed
Summary

This study introduces an agentic workflow to create drug safety summaries from diverse data. The system integrates multiple tools to identify drug safety patterns and support regulatory review.

Keywords:
FAERSOpenFDAagentic AIcytochrome P450large language modelsliterature retrievalpharmacovigilancereproducibilitysafety signal

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A Data Integration Workflow to Identify Drug Combinations Targeting Synthetic Lethal Interactions
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Published on: May 27, 2021

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Last Updated: May 24, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

A Data Integration Workflow to Identify Drug Combinations Targeting Synthetic Lethal Interactions
07:40

A Data Integration Workflow to Identify Drug Combinations Targeting Synthetic Lethal Interactions

Published on: May 27, 2021

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Computational Pharmacology
  • Artificial Intelligence in Medicine

Background:

  • Existing methods for analyzing adverse event data are often isolated.
  • Automated summarization, retrieval-augmented generation, and agent-based systems lack integration.
  • There is a need for reproducible and context-aware drug safety summarization.

Purpose of the Study:

  • To develop and validate an integrated agentic workflow for generating concise and reproducible drug safety summaries.
  • To leverage heterogeneous safety evidence, including FAERS data and pharmacokinetic information.
  • To support early drug safety signal triage and review processes.

Main Methods:

  • Integration of automated FAERS summarization, retrieval-augmented generation, and tool-driven agents into a schema-aware pipeline.
  • Utilizing OpenFDA for data querying and incorporating cytochrome P450 (CYP) enzyme mappings.
  • Implementing deterministic execution, versioning, and caching for reproducibility and auditability.
  • Generating structured safety briefs with narratives and figures from computed tables.

Main Results:

  • The workflow successfully processed data for 110 drugs, identifying cross-drug patterns in severe outcomes.
  • Specific drugs were identified as leaders for adverse events like death and hospitalization.
  • Case examples demonstrated how co-reporting patterns and CYP context provide mechanistic insights.

Conclusions:

  • The developed agentic workflow provides a reproducible method for summarizing drug safety evidence.
  • Structured safety briefs generated by the workflow aid in safety committee reviews and signal triage.
  • The system facilitates the selection of targets for further pharmacoepidemiologic studies.