docs

BioEq Documentation

This directory contains comprehensive documentation for the BioEq package.

Directory Structure

Regulatory Documentation

• validation/: Validation strategy and traceability matrix
• requirements/: Functional requirements specification
• specifications/: Detailed algorithmic specifications
• references/: Regulatory references and guidelines
  • pdf/: PDF copies of referenced regulatory documents

Development Documentation

• development/: Documentation for developers
  • DOCUMENTATION.md: Poetry usage and development workflows
  • WORKFLOW_DOCUMENTATION.md: Development workflow with notebooks

Bioequivalence Notes

• notes/: Notes on bioequivalence concepts
  • BE_NOTES.md: Detailed notes on bioequivalence concepts
  • concise_BE_NOTES.md: Concise summary of key bioequivalence concepts

Important Documentation

For Regulatory Purposes

• Validation Strategy: validation/validation_strategy.md
• Functional Requirements: requirements/functional_requirements.md
• Traceability Matrix: validation/traceability_matrix.md
• Algorithmic Specifications: specifications/algorithmic_specifications.md
• Regulatory References: references/regulatory_references.md

For Developers

• Development Workflows: development/DOCUMENTATION.md
• Notebook Integration: development/WORKFLOW_DOCUMENTATION.md