Table. 1.

Time windows for screening examinations

First-in-human trials	•Check laboratory values and inclusion/exclusion criteria within 3 days prior to first dosing
	•If screening performed earlier than 3 days prior to first dosing, repeat laboratory assessments and check whether relevant changes/important events occurred
Trials with ‘clinically established IMPs’ (e.g. bioequivalence trials for generic medicines applications)	•Screening examination usually between −21 and −1 days prior to first dosing; take risk-adapted approach

IMP investigational medicinal product