A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the…
Two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after…
A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic…
A medicine that contains one or more active biological substances. A biological substance is produced by or extracted from a biological source and…
The degree to which individuals (health professionals or patients) can obtain, comprehend, communicate, calculate and process patient-specific…
A biological medicine that is developed to be similar to an existing biological medicine (the 'reference medicine'). Biosimilar medicines can only be…