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B

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.

Biobank

A 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, such as whether the donor had been exposed to some substance that can affect health. Biobanks play a crucial role in biomedical research, such as in genomics and personalised medicine. Researchers access biobanks when they need samples with similar characteristics for their research studies.

Bioequivalence

Bioequivalence 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 to compare an original and generic version of a medicine, or two different formulations (for instance, tablet or oral suspension) of the same medicine.

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 the bioequivalence with the reference (original) medicinal product must be demonstrated for a generic to be approved. Regulatory authorities evaluate bioequivalence by considering two standards: the rate of absorption and the extent of absorption. If a medicine formulation differs in one or both parameters, the authorities would determine that this medicine is not bioequivalent to the original product.

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 title ˜ELSI™, which stands for ˜ethical, legal and social issues™.

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

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 about the progression of multiple sclerosis.

Biomarkers are used in many scientific fields. They are used in different ways at different stages of medicines development, including in some cases as a surrogate endpoint to indicate and measure the effect of interventions, such as medicines, in trials.

For example, haemoglobin levels have been used in Phase III trials to support development of therapies for Type 1 Gaucher disease (a rare disease that affects multiple organ systems and shortens life expectancy, but which can take years to show changes in clinical symptoms).

Biosimilar Medicinal Products Working Party


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™. Biosimilars may only be marketed after the patent for the reference medicinal product has expired, although they may be developed earlier. A biosimilar medicine and its reference medicinal product are expected to have the same safety and efficacy profile.

Biosimilar medicines are developed to have the same mechanism of action, and to treat the same diseases as the reference medicinal product. Standards of the EU Good Manufacturing Practice (GMP) apply to the manufacture of biosimilar medicines in the same way as for any other biological medicinal product. Biosimilar medicines may offer a less costly alternative to existing biological medicinal products that have lost their exclusivity rights.

Biotechnology

Any technological application of living systems, biological processes or organisms, to develop or make useful products or new technologies.


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