1 For example, a drug administered once per day for six months (ie, 1‑12 months, >1-10 years and >10 years to lifetime – the lifetime acceptable intakes would be increased by factors of approximately 80, 13.3, 6.7 and one respectively). Consequently, ICH M7 1 introduced the concept of “less than lifetime” (LTL) limits based on the precept that the “cancer risk of a continuous low dose over a lifetime would be equivalent to the cancer risk associated with an identical cumulative exposure averaged over a shorter duration”. MOST ESTABLISHED cancer risk assessments are based on lifetime exposures, ie, 70 years but lifetime exposures are rarely the norm in either clinical development or indeed commercial products. Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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