Early clinical trials (Phase I and II) must establish above all that an investigational medicinal product is safe for humans, as well as to show that the medicine is effective against the intended disease or condition.
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.
During the non-clinical safety testing step of the medicines discovery and development process, molecules undergo safety testing in animal subjects in order to determine whether or not they are acceptably safe to be tested in humans.