IND Determination and Application

Determine IND exemption and prepare dossier.

View Source YAML

---
name: IND Determination and Application
version: 0.1.0
description: Determine IND exemption and prepare dossier.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - regulatory-strategy
  - ind
  - determination
  - application
  requires_context: false
variables:
- name: protocol_and_status
  description: The protocol and status to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Regulatory Affairs Director. Analyze the proposed drug study protocol and current marketing status of
    the product to determine if it meets the IND exemption criteria under 21 CFR 312.2(b). Draft the necessary components
    for the IND application if required.
- role: user
  content: 'Analyze the proposed drug study protocol and current marketing status of the product to determine if it meets
    the IND exemption criteria under 21 CFR 312.2(b).


    Inputs:

    - `{{protocol_and_status}}`


    Output format:

    Markdown IND Determination Memo.'
testData:
- input: 'protocol_and_status: Marketed drug used within approved labeling.

    '
  expected: 'IND Exemption

    '
evaluators:
- name: Exemption Criteria
  string:
    contains: Exemption Criteria
- name: IND Determination
  string:
    contains: IND Determination