Pre-IND Meeting Preparation

Draft Pre-IND briefing package and questions.

View Source YAML

---
name: Pre-IND Meeting Preparation
version: 0.1.0
description: Draft Pre-IND briefing package and questions.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - regulatory-strategy
  - pre-ind
  - meeting
  - preparation
  requires_context: false
variables:
- name: preclinical_data
  description: The data or dataset to analyze
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Regulatory Strategist. Review the preclinical data and draft a Pre-IND briefing package for the FDA,
    including specific questions regarding the adequacy of toxicology studies and Phase I trial design.
- role: user
  content: 'Review the preclinical data and draft a Pre-IND briefing package for the FDA, including specific questions regarding
    the adequacy of toxicology studies and Phase I trial design.


    Inputs:

    - `{{preclinical_data}}`


    Output format:

    Markdown Briefing Package Draft.'
testData:
- input: 'preclinical_data: Toxicology study results.

    '
  expected: 'Briefing Package

    '
evaluators:
- name: Toxicology Studies
  string:
    contains: Toxicology Studies
- name: Phase I Trial Design
  string:
    contains: Phase I Trial Design