In Phase II trials, the investigational medicinal product is tested for efficacy (and safety). The studies conducted are typically therapeutic exploratory studies which try to discover whether the medicine treats the intended disease or condition.
Early Clinical Development refers generally to the first studies of a medicine in humans – typically known as Phase I and Phase II trials. Studies in early clinical development focus on the safety and tolerability of the new medicine. They also try to show that the medicine can have the intended effect.
Pharmacology is the study of how a medicine works, how the body responds to it, and the changes that occur over time. There are two key areas of pharmacology: pharmacokinetics and pharmacodynamics. Pharmacological data is crucial for benefit-risk assessments and determining dose schedules.