Non-clinical toxicity studies investigate the safety profile of a medicine. Candidate compounds must undergo many different toxicity studies before they are first administered in clinical trials or receive marketing authorisation.
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.
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.
Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the greatest probability of success, assess safety, and build solid scientific foundations before the transition to clinical development phases.
There are several types of non-clinical study, each with its own objectives and specific requirements for completion.
Galenic formulation deals with the principles of preparing and compounding active ingredients into ready-to-use medicines in order to optimise their absorption by the body.