Tolerability

Careful consideration of various factors is necessary before progressing from non-clinical to clinical studies and setting the first-in-human dose.

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.

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.

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.