SUMMARY
The discussion centers on the need for resources to analyze drugs in compliance with FDA regulations, specifically focusing on physical and chemical attributes. Participants recommend consulting the ICH Q2(r1) validation document for new validations and suggest using pharmacopoeial methods for existing drugs. Additionally, the OECD document on physical chemistry testing procedures is highlighted as a valuable resource for understanding drug attributes such as tablet hardness and composition. Overall, the consensus is that both books and reputable websites can provide essential information for FDA-compliant drug analysis.
PREREQUISITES
- Understanding of FDA regulations regarding drug analysis
- Familiarity with ICH Q2(r1) validation guidelines
- Knowledge of pharmacopoeial methods for drug testing
- Basic principles of physical chemistry related to drug attributes
NEXT STEPS
- Research the ICH Q2(r1) validation document for analytical method validation
- Explore pharmacopoeial methods for existing drug analysis
- Review the OECD guidelines on physical chemistry testing procedures
- Investigate resources on tablet hardness testing and composition analysis
USEFUL FOR
This discussion is beneficial for pharmaceutical researchers, quality control analysts, and regulatory affairs professionals involved in FDA-compliant drug analysis and validation processes.