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European Medicines Agency (EMA) | European Competent Authority. http://www.ema.europa.eu“
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- Biologic medicinesBiologic medicines, or protein-based medicines such as insulin, are designed to interact with specific targets in the patient’s body. A more targeted mechanism of action should lead to a greater chance of the medicine having the desired effect against the disease and should result in fewer side effects than traditional medicines.
- NanoparticlesNanoparticles are tiny objects, available only as intravenous formulations, that help medicines get to difficult-to-reach cells and tissue. They can also help protect molecules and control the targeted release of medicines.
- Clinical trials in small populationsSmall populations present ethical and practical challenges to organising clinical trials. Small populations include groups with rare diseases or specific sub-types of common diseases, children, and the elderly.
- Non-clinical development: Basic principlesNon-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.
- The predictive value of non-clinical testingData 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.