Clinical Phase of Trials:
PHASE I – Usually in Healthy volunteers to determine safety and dosage 15-20 participants.
PHASE II – Are used to get initial reading of efficiency and further explore safety in small number of sick patients. 100-300 participants.
PHASE III – These trials are large, pivotal trials to determine safety and efficacy in sufficiently large no. of patients 300-3000.
PHASE IV – Post marketing surveillance.
Pre clinical Phase | - | In vivo/In vitro |
Phase O | - | Human Micro dosing study |
Phase I | - | Human Pharmacology study |
Phase II | - | Therapeutic exploratory trial |
Phase III | - | Therapeutic Confirmatory |
Phase IV | - | Post Marketing surveillance trial |