Clinical phase

The clinical phase of medicines development is the one involving humans, and is different from the ‘non-clinical’ or ‘pre-clinical phase’ in which studies are performed in labs or in animals (such as for pharmacology/toxicology analysis). Clinical studies are conducted in four steps, called ‘phases’ – each designed to answer separate research questions:

: The four phases of clinical development differ in terms of their objectives and features.

Non-clinical development: Basic principles
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.
Key principles of pharmacology
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.

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