- clinical trial phases

Clinical trial phase that is conducted in laboratories and on animals before human testing begins

Preclinical trials

Clinical trial phase that aims to evaluate safety, pharmacokinetics and pharmacodynamics, as well as determine the optimal dosage range in a small population of healthy human volunteers

Phase I

Clinical trial phase that tests for efficacy and adverse effects in a larger group of patients (compared to its previous trial) with the targeted disease, not healthy volunteers

Phase II

Clinical trial phase that aims to confirm the efficacy identified in its previous trial and further assess safety in a much larger population with the targeted disease

Phase III

Clinical trial performed after a drug receives FDA approval to monitor long-term safety and efficacy

Phase IV