Breaking out a topic just starting to be discussed by @Aline_Salgado and @JavierFernandez to get more visibility as I have a similar question.
I have a couple of products that are administered monthly, or in the case Aline mentioned, 7 days per month. My presumption is that just as the cumulative nature of nitrosamine risk was shown by @SusanFelter and team, a similar study would be needed for these cases, but I would love to hear from some of our toxicologists.
Hi Jason
Normally in the ICH m7 evaluations of duration of treatment, you need to count only the dosing days. 7 days per month is 84 days per year. Sometimes the tricky part is to evaluate the number of years and the total duration of treatment, since label of a product normally states the usage of single treatment, but you have to take into account the total number of times you can take during lifetime (established at 70 years on ICH M7). For example, an antibiotic may be used for a week, but over a lifetime? Probably there is some people that end up taking 1 week of antibiotics per year on average? That would put you in the 1-10 years window.
My advice here is, in case of doubt, go for the worst-case always