The Expert Working Group re-evaluated the data supporting the Cadmium inhalation PDE and concluded that a modifying factors approach, similar to that used for calculating the oral and parenteral PDEs, was appropriate for the inhalation PDE. The corrected value resulted in 3.4 μg/day.

Comments on the ICH Q3D(R1) draft revision document can be entered by e-mail to the ICH Secretariat. More details can be found under the Public Consultation page.

Source:

ICH: Newsroom