How do I caluclate a Permitted Daily Exposure value for an elemental impurity in another route of administration in ICH 3QD?

Hello all, Hope you can help! Currently in ICH 3QD there is a PDE value for silver  as an elemental impurity for parental but not for opthalmic (eye) route in the USA. Can anybody help in advising...

26 July 2017 4,695 5 View