What's the right approach to address the intrinsic issue of limits?

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?