Advices are needed for LTL approach

[Naiffer_Host]

@ejdowse thank you for sharing the insights from last week’s discussion at the PhRMA workshop.

@jxl Less-Than-Lifetime (LTL) continues to be a center stage topic at any discussion related to limits. Can you elaborate on the concern and proposals from local stakeholders? Did they share why LTL?

We have a great discussion thread where @SusanFelter and @David share their perspectives and agreement on the precautionary approach VS data-based. We have also seen ANVISA (Brazil) including the LTL approach in the guidance draft.

Is LTL approach getting traction and acceptance among regulatory agencies? Any other agency taking Brazil’s position on LTL?

LTL or not LTL that's the question?

@SusanFelter Once again thank you for becoming part of our community. I had opportunity to read some of your published work (‘A proposed framework for assessing risk from less-than-lifetime exposure to carcinogens’. ICH M7(R1) defined a sub-class of MIs described as the Cohort of Concern (CoC), including N-nitroso compounds. However, there is still debate about the use or not of LTL for this family of compounds when defining acceptable limits. Do you think there is even room for debate on this?