Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.
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.
A rigorous non-clinical programme must be completed before a medicine may be tested in humans for the first time in Phase I clincial trials.
The animal models used in non-clinical trials are carefully selected, taking various factors into consideration.