5 Questions
What is the purpose of the ICH Harmonised Tripartite Guideline?
To provide specifications for new drug substances and products
What is the significance of reaching Step 4 of the ICH Process?
The final draft is recommended for adoption to regulatory bodies
What does the ICH Guideline specify?
Test procedures and acceptance criteria for new drug substances and products
What is the purpose of the ICH Process?
To recommend drug substances for adoption to regulatory bodies
What happens at Step 2 of the ICH Process?
Approval by the Steering Committee and release for public consultation
Test your knowledge of the ICH Harmonised Tripartite Guideline Specifications for New Drug Substances and New Drug Products with a focus on chemical substances under Q6A. This quiz covers the current Step 4 version dated 6 October 1999 and is based on the guidelines developed by the ICH Expert Working Group.
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