Food and Drug Administration [FDA]« Back to Glossary Index
« Back to Glossary Index
- 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.
- Bioavailability and bioequivalenceBioavailability 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 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.
- Paediatric medicine: Special considerationsSpecial considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
- Paediatric medicine: Regulations and other influencersThe regulations governing paediatric medicine differ between the EU and the US.