Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

1.9K
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...
1.9K
Preclinical Development: Overview01:28

Preclinical Development: Overview

6.2K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.2K
Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

1.9K
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
1.9K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

510
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
510
Clinical Trials01:16

Clinical Trials

11.0K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
11.0K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.2K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.2K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Genetic diversity and occurrence of antibiotic resistance genes from community wastewater in Dhaka and Cox's Bazar, Bangladesh.

One health (Amsterdam, Netherlands)·2026
Same author

Biomarkers.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2025
Same author

Developing an Anatomically Valid Segmentation Protocol for Anterior Regions of the Medial Temporal Lobe for Neurodegenerative Diseases.

Hippocampus·2025
Same author

Oxidative Activation of the Heme Nitric Oxide/Oxygen-Binding Protein (H-NOX) from <i>Caulobacter crescentus</i>.

Biochemistry·2025
Same author

Developing an anatomically valid segmentation protocol for anterior regions of the medial temporal lobe for neurodegenerative diseases.

bioRxiv : the preprint server for biology·2025
Same author

Phase 1 clinical trial of B-Cell Maturation Antigen (BCMA) NEX-T® Chimeric Antigen Receptor (CAR) T cell therapy CC-98633/BMS-986354 in participants with triple-class exposed multiple myeloma.

Leukemia·2025

Related Experiment Video

Updated: Mar 5, 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

10.3K

Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and

Alfred Sorbello1, Anna Ripple, Joseph Tonning

  • 1Alfred Sorbello, DO, MPH, US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 USA,

Applied Clinical Informatics
|March 23, 2017
PubMed
Summary

A new software tool aids FDA reviewers in detecting adverse drug event (ADE) safety signals from scientific literature. Usability testing confirmed its effectiveness and ease of use for pharmacovigilance.

Keywords:
Pharmacovigilancedata miningsoftware designtranslational researchuser-computer interface

More Related Videos

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
07:50

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

16.6K
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

5.6K

Related Experiment Videos

Last Updated: Mar 5, 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

10.3K
A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
07:50

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

16.6K
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

5.6K

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Computational Biology and Bioinformatics
  • Medical Informatics

Background:

  • Regulatory agencies like the FDA require robust methods for detecting adverse drug events (ADEs) from scientific literature.
  • Existing methods for analyzing large volumes of scientific literature for pharmacovigilance can be time-consuming and resource-intensive.

Purpose of the Study:

  • To develop and evaluate a prototype software tool to enhance the FDA's ability to identify ADE safety signals from PubMed/MEDLINE literature.
  • To gather user feedback on the tool's design, performance, and overall satisfaction through usability testing.

Main Methods:

  • Developed an open-source, web-based software tool utilizing statistical disproportionality data mining and visual analytics.
  • Employed Medical Subject Heading (MeSH) terms from PubMed/MEDLINE to identify potential drug-adverse event pairs.
  • Conducted usability testing with six FDA regulatory reviewers using the tool in their real-world pharmacovigilance tasks.

Main Results:

  • Usability testers found the tool easy to learn and use, successfully generating quantitative ADE safety signals, some aligning with known adverse drug reactions.
  • Feedback highlighted the tool's potential value in automating literature-based safety signal detection.
  • Concerns were raised regarding automated search comparability, term completeness, signal interpretation, and integration with existing systems.

Conclusions:

  • The prototype tool demonstrates the potential to automate ADE safety signal detection from published literature for pharmacovigilance.
  • Usability testing provided valuable insights for improving the tool's design, efficiency, and user satisfaction.