Peer-Reviewed Publications
Signal Detection
2025
Domain-Specific AI Models vs General-Purpose LLMs for Pharmacovigilance Tasks
Comparative analysis demonstrating superior performance of purpose-trained domain models for adverse event extraction, MedDRA auto-coding, and causality assessment. Evaluation across 10,000+ FAERS case narratives shows 92% precision vs 67% for GPT-4.
Journal: Artificial Intelligence in Medicine
Authors: Chen S, Torres M, Liu J, Patel P
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BRA Methodology
2024
Multi-Criteria Decision Analysis in Pharmaceutical Benefit-Risk Assessment
Systematic review and implementation guide for MCDA methods in benefit-risk assessment. Covers swing weighting, SMAA, and stochastic acceptability analysis with regulatory acceptance considerations for FDA and EMA submissions.
Journal: Value in Health
Authors: Chen S, Kowalski A, Rodriguez E
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Signal Detection
2024
AI-Driven Disproportionality Analysis for Post-Marketing Signal Detection
Novel methods integrating traditional disproportionality metrics (PRR, ROR, MGPS, BCPNN) with deep learning for enhanced signal detection. Validation on 15 years of FAERS data demonstrates 3x improvement in early signal detection vs standard methods.
Journal: Journal of Pharmacoepidemiology
Authors: Torres M, Patel P, Chen S
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AI in Pharma
2024
Natural Language Processing for Adverse Event Extraction from Regulatory Documents
Transformer-based NLP models for automated extraction of adverse event terms from unstructured clinical narratives, literature, and regulatory submissions. Domain-specific pre-training on pharmacovigilance corpora achieves 94% F1 score.
Journal: BMC Medical Informatics and Decision Making
Authors: Liu J, Rodriguez E, Torres M
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BRA Methodology
2023
Quantitative Benefit-Risk Assessment Using BRAT Framework: A Platform Approach
Practical implementation of the Benefit-Risk Action Team (BRAT) framework within a software platform. Demonstrates automated value tree construction, effects table generation, and scenario modeling aligned with FDA and EMA guidance.
Journal: Drug Safety
Authors: Chen S, Patel P, Kowalski A, Torres M
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Regulatory Science
2023
Automating PSUR/PBRER Generation: A Regulatory Science Perspective
Framework for automated generation of Periodic Safety Update Reports (PSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER) compliant with ICH E2C(R2). Validation study across 20 submissions demonstrates regulatory acceptance with 60% time reduction.
Journal: Therapeutic Innovation & Regulatory Science
Authors: Rodriguez E, Chen S, Liu J
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