Search results with tag "Addendum to the guideline on testing for"

ADDENDUM TO THE GUIDELINE ON TESTING FOR …

ICH S1B(R1) Guideline 2 31 been assessed adequately based on a comprehensive assessment of all available 32 pharmacological, biological, and toxicological data (2-9). 33 To determine whether the conclusions from these retrospective analyses could be confirmed in 34 a real- world setting (i.e., prior to knowledge of the 2-year rat carcinogenicity study outcomes),

  Guidelines, Testing, Addendum, Addendum to the guideline on testing for