Regulators have long grappled with different approaches to address this intrinsic issue. Strategies includes:
- Risk Based Assessments (ICH M7)
- Avoidance of N-Nitrosamine Impurities
- Safety based limits, including permissible daily limits
- Threshold of toxicological concern (TTC)
- Less than lifetime (LTL)
- Acceptance intakes (AI)
What’s a meaningful way forward?
