Glossary

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  • Bioassay
    A 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.
  • Bioequivalence Study
    A 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(...)
  • Bioethics
    Bioethics 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 Medicine
    A 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(...)
  • Biomarker
    A 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 Party
    Biosimilar Medicinal Products Working Party (BMWP) http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000024.jsp"
  • Biosimilar Medicine
    A biosimilar medicine is a biological medicine which is similar to another biological medicine that has already been authorised for use. Biosimilar medicines are commonly known as biological generic medicines. The existing biological medicine is known as the ‘reference medicinal product’.(...)
  • Biotechnology
    Any technological application of living systems, biological processes or organisms, to develop or make useful products or new technologies.
  • BMWP
    Biosimilar Medicinal Products Working Party (BMWP) http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000024.jsp"
  • Bona fide
    Carried out in good faith; honest, without fraud or deception.
  • Branded Medicines
    Branded medicines are medicines which have a name given to them by a company for the purpose of advertising. The names of branded medicines are different from the International Nonproprietary Name (INN), also known as the generic name. Branded medicines may be the original medicine developed(...)

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