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Project deep-dive: context, challenges, value, deliverables, data & learning with AI #2

Description

@ds4cabs

👋 @MatiPinto03 — context for OpenRegEval, your regulatory-label evaluation dashboard.

1. Basic context

Drug labels (FDA SPL / DailyMed, EMA SmPC) are the authoritative source of indications, dosing, warnings, and contraindications. OpenRegEval is an interactive comparator that scores outputs/variants against label sections side-by-side — useful for evaluating AI-generated summaries against ground-truth regulatory text.

2. Key challenges in this field

  • Structured parsing of semi-structured SPL/XML label sections.
  • Ground-truth & hallucination — verifying claims against the exact label section; catching fabricated dosing/warnings.
  • Section alignment — labels differ in structure across drugs and agencies.
  • Scoring rubric design — turning "is this faithful?" into reproducible metrics.

3. Research value — why this matters

Regulatory text is high-stakes: an incorrect contraindication or dose can harm patients. Reliable, auditable evaluation of AI outputs against labels is foundational to trustworthy pharma AI.

4. What you can deliver

A Streamlit comparator with a model/variant selector, label-section filters, and side-by-side scorecards (faithfulness, completeness, coverage) with the supporting label snippet shown for each judgment.

5. Functions / scripts that will be popular

  • parse_spl(label_xml) → structured sections; fetch_label(drug) from DailyMed/openFDA.
  • A faithfulness scorer (claim ↔ source-snippet matching) and a diff/highlight renderer.

6. Data that might be helpful

openFDA Drugs@FDA & label API, DailyMed SPL, EMA SmPC, FDA Orange Book; a small hand-labeled gold set for calibration.

7. How to use AI to self-learn and go deeper

  • Ask AI to explain label section semantics (e.g. boxed warning vs. warnings/precautions).
  • Have it draft evaluation rubrics, then red-team them by generating tricky near-miss cases.
  • Use it as a second grader and compare against your scorer to find disagreements.

Reply here with your own answers to these prompts — especially #4 (what you'll deliver) and #7 (how you're using AI to learn). Treat this as your project's living design doc.

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