Binary EndpointThe endpoint of a clinical trial is the measurement (such as change in tumour size) used to decide whether there is a significant difference between different arms of the trial (for example, whether a medicine under study is having a positive effect).There are different types of endpoints. A(...)
BioassayA common short term used for biological assay or assessment. It is a type of scientific experiment that involves the use of live animals, plants, tissues or cells to determine the biological activity of a substance. Bioassays are essential in the development of new medicines.
BiobankA biobank is a large, organised collection of samples, usually human, used for research. Biobanks catalogue and store samples using genetic, clinical, and other characteristics such as age, gender, blood type, and ethnicity. Some samples are also categorised according to environmental factors,(...)
BioequivalenceBioequivalence means that the identical active pharmaceutical ingredient of two medicines have the same rate and extent of absorption. The medicines produce the same effect at the required target. For example, a receptor in the brain can be a target for a medicine. Bioequivalence is often used(...)
Bioequivalence StudyA bioequivalence study is a study conducted to show that two medicines, or two different dosages of the same medicine, are equally absorbed after administration and produce the same effect at the required site.For generic medicinal products, the concept of bioequivalence is fundamental since(...)
BioethicsBioethics is the application of ethics to the fields of medicine, biomedical research and health policy. It has become an important area of enquiry as advances are made especially in genetic medicine and reproduction. The ethical aspects of research and policy are often included under the(...)
Biologic MedicineA biologic medicine is any medicinal product manufactured in, extracted from, or synthesised in part from biological sources. Biologics can be composed of sugars, proteins, or nucleic acids; they may be complex combinations of sugars, proteins, or nucleic acids; or they may be living cells or(...)
BiomarkerA biological marker is something that can be measured which points to the presence of a disease, a physiological change, response to a treatment, or a psychological condition. For example, glucose levels are used as a biomarker in managing diabetes, and brain images can provide information(...)
Biosimilar Medicinal Products Working PartyBiosimilar Medicinal Products Working Party (BMWP) https://www.ema.europa.eu/en/committees/working-parties-domains/chmp/biosimilar-medicinal-products-working-party
BMWPBiosimilar Medicinal Products Working Party (BMWP) https://www.ema.europa.eu/en/committees/working-parties-domains/chmp/biosimilar-medicinal-products-working-party
