Food and Drug Administration [FDA]

Biologic 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.

Bioavailability is the fraction (percentage) of an administered dose of unchanged drug that reaches the blood stream (systemic circulation). Bioavailability varies between different pharmaceutical ingredients and mode of administration.

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.

Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.

The regulations governing paediatric medicine differ between the EU and the US.