Can anybody add clarity what is the basis of EMA selection of TD50’s for different nitrosamines?
Some are based on lowest TD50 of CPDB
Some are based on lowest TD50 of LCDB
Some are based on most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) applying the lower boundary of the 99% CI for the TD50 estimate (TD50L01).
Some are based on most sensitive TD50 derived from the most robust TD50 dataset from Lhasa carcinogenic potency database (LCDB).
As per I had communication with EMA, they suggested to prefer LCDB more than CPDB due to data refinement in LCDB. But still i see EMA using CPDB as basis, whenever it is conservative than LCDB.