The European Patients’ Academy (EUPATI) guidance document on patient involvement in industry-led medicines R&D aims to support the integration of patient involvement across the entire process.
During clinical development the manufacturing and distribution facilities available may not be suitable for a trial medicine (investigational medicinal product (IMP)), however, IMPs must be manufactured, stored and distributed in accordance with good manufacturing practice guidelines (GMP) to ensure that the IMP can be safely administered to trial participants.
GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and distribution of medicines. GxP rules and guidelines ensure that all aspects of the medicines development process are conducted according to the best methods for safety, efficacy, and quality.
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
Translational medicine, a rapidly growing, multi-disciplinary approach in biomedical research, converts promising laboratory discoveries into clinical applications.
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.
Once a target receptor molecule or an enzyme has been identified, scientists begin to look for potential compounds that will interact with the target to correct disease-related activity.These molecules go through a long and careful process to be developed into medicines.
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.