Last Updated: 09/26/2026
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Found 11 publications
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case.
Journal: Therapeutic innovation & regulatory science
Published: December 18, 2024
Algorithmic identification of treatment-emergent adverse events from clinical notes using large language models: a pilot study in inflammatory bowel disease.
Journal: medRxiv : the preprint server for health sciences
Published: September 21, 2023
Algorithmic Identification of Treatment-Emergent Adverse Events From Clinical Notes Using Large Language Models: A Pilot Study in Inflammatory Bowel Disease.
Journal: Clinical pharmacology and therapeutics
Published: September 12, 2023
Assessing adverse events in clinical trials during the era of the COVID-19 pandemic.
Journal: Journal of biopharmaceutical statistics
Published: January 31, 2023
Important Considerations for Signal Detection and Evaluation.
Journal: Therapeutic innovation & regulatory science
Published: December 04, 2022
A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group.
Journal: Therapeutic innovation & regulatory science
Published: February 04, 2021
Interdisciplinary Safety Evaluation for Learning and Decision-Making.
Journal: Therapeutic innovation & regulatory science
Published: October 07, 2020
A Framework for Safety Evaluation Throughout the Product Development Life-Cycle.
Journal: Therapeutic innovation & regulatory science
Published: September 05, 2019
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.
Journal: Therapeutic innovation & regulatory science
Published: November 16, 2018
Showing 1-11 of 11
Last Updated: 09/26/2026