Overview
ICH
The companies were asked to characterize the target class for the compound (Table Target class*Other (With regard to the MTA nonclinical toxicology FIP-enabling packages, 74% were conducted after the implementation of ICH S9. The dosing route was oral in 86% of cases for both nonclinical and clinical studies. The majority of nonclinical dosing regimens were daily for 4 weeks (75% of rodent and 74% of non-rodent studies), corresponding to continuous daily clinical dosing (59%). The distribution of compounds that identified a NOAEL, STD10, or HNSTD is summarized in Table Distribution of NOAEL, STD10, and HNSTD for submitted compounds