Phase I - Human Pharmacology
4. Sequence and Interval Between Dosing of Participants
- Usually, a single participant receives a single dose of the active investigational medicine.
- Further dose administration should be sequential within each cohort to mitigate the risk.
- There must be an adequate period of observation between the administration of the medicinal product to the first, second and subsequent participants in a cohort to observe and interpret reactions.
- Administration in the next cohort should not occur before participants in the previous cohort have been treated and data/results from those participants are reviewed.