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B

Best supportive care

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.

Bias

In clinical trails, bias is the systematic deviation from true values of treatment effect through the intentional or unintentional adjustment of results. Bias can result from aspects of trial design, the way a trial is carried, or the way the results are analysed or evaluated.

Bias can be ˜operational™ “ when it arises because of the way a trial is carried out or ˜statistical™ “ when it arises because of trial design or the way results are analysed or evaluated

For example, poor trial design might mean that participants at lower risk of experiencing a symptom are placed in one treatment arm as opposed to another treatment arm. Excluding data from certain participants because of knowledge of their outcomes would also cause bias in a trial.

The most important design techniques for avoiding bias in clinical trials are blinding and randomisation. The potential effect of bias should also be taken into account during statistical analysis of trial data.

Big data

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.

Binary Endpoint

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 binary endpoint is defined by whether an event has occurred or not (for example, the relief of symptoms, or occurrence of disease symptoms). It does not imply a certain magnitude of an effect. It is a Yes/No construct.

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


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