Glossary

In medicines R&D, benefit-risk assessment is the continuous examination of the favourable and unfavourable results of a specific treatment to determine whether its benefits outweigh its risks in a -specific condition. It takes into account the evidence on safety and efficacy, as well as other(...)

Best supportive care (BSC) is the treatment of choice when a cure is not achievable with existing treatments. It involves the management of disease-related symptoms.

Big data in the health sector is the combination and analysis of very large and diverse sets of data, such as non-health and health data, ongoing generation of information about the real-world use of medicines, patient-generated data from social media, and wearable devices.

The 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(...)

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.

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 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(...)

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(...)

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(...)

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’.(...)

Best supportive care (BSC) is the treatment of choice when a cure is not achievable with existing treatments. It involves the management of disease-related symptoms.