The US Food and Drug Administration on 29 September issued a draft question-and-answer document on the International Council on Harmonisation's M7 guideline that specifies the validation principles that pharmaceutical manufacturers should follow when using computational modeling methods for measuring genotoxic impurities in new drugs. These methods will replace in vitro animal tests for assessing impurities.
The Q&A is intended to “clarify, promote the convergence for measuring genotoxic impurities in new drugs, and improve the harmonization” in assessing and controlling DNA reactive, or
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?