Test Procedures and Acceptance Criteria for New Drugs
Background
The International Conference on Harmonization (ICH) has developed guidelines (ICH Q8) for testing and acceptance criteria for new drugs.
Key Points
The guidelines provide recommendations on:
- Information to be included in drug development plans
- Test procedures to determine drug quality
- Acceptance criteria for drug release characteristics
The guidelines are intended to harmonize drug development and testing procedures across different countries.
Implications
The guidelines will help to ensure the quality and safety of new drugs by providing a common framework for testing and acceptance criteria.
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