ib-summarizer

name	ib-summarizer
description	Summarize core safety information from Investigator's Brochures for clinical researchers
version	1.0.0
category	Pharma
tags	[]
author	AIPOCH
license	MIT
status	Draft
risk_level	Medium
skill_type	Tool/Script
owner	AIPOCH
reviewer
last_updated	2026-02-06

IB Summarizer

Description

Summarize core safety information from Investigator's Brochures (IB), helping clinical researchers quickly obtain key drug safety data.

Functions

• Extract Core Safety Information (CSI) from IB documents
• Identify and summarize:
  • Known Adverse Drug Reactions (ADRs) and their incidence rates
  • Contraindications
  • Warnings and Precautions
  • Drug Interactions
  • Special population precautions
  • Overdose Management
  • Important safety updates

Usage

python scripts/main.py <input_file> [options]

Parameters

Parameter	Type	Default	Required	Description
input_file	string	-	Yes	IB document path (PDF/Word/TXT)
-o, --output	string	stdout	No	Output file path
-f, --format	string	markdown	No	Output format (json, markdown, text)
-l, --language	string	zh	No	Output language (zh, en)

Examples

# Basic usage
python scripts/main.py /path/to/IB.pdf

# Output to JSON file
python scripts/main.py /path/to/IB.pdf -o summary.json -f json

# English output
python scripts/main.py /path/to/IB.docx -l en -o summary.md

Output Structure

Markdown Format

# IB Safety Information Summary

## Basic Drug Information
- **Drug Name**: XXX
- **Version**: X.X
- **Date**: YYYY-MM-DD

## Core Safety Information

### Known Adverse Reactions
| System Organ Class | Adverse Reaction | Incidence | Severity |
|-------------|---------|--------|---------|
| ... | ... | ... | ... |


 ...


 ...


 ...


| Population | Precautions |
|-----|---------|
| Pregnant women | ... |
| Lactating women | ... |
| Children | ... |
| Elderly | ... |
| Hepatic/renal impairment | ... |


 Symptoms: ...
 Management: ...


| Version | Date | Update Content |
|-----|------|---------|
| ... | ... | ... |