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B

Bacteriology

A subdivision of microbiology that involves the identification, classification, and characterisation of bacteria.

Baseline Assessments

Baseline assessments are carried out with participants as they enter a trial and before they receive any treatment.

These assessments may take the form of interviews, questionnaires, physical examinations, laboratory tests, or other procedures. Baseline assessments include demographics (such as age, gender), patient characteristics (such as height, weight, blood pressure), and measurements specific to the study (such as disease characteristics or previous treatment).

Baseline Data

Baseline data provide information about participants as they enter a trial and before they receive any treatment.

Baseline data collection may take the form of interviews, questionnaires, physical examinations, laboratory tests, or other procedures. Baseline data include demographics (such as age, gender), patient characteristics (such as height, weight, blood pressure), and measurements specific to the study (such as disease characteristics or previous treatment).

Beneficence

Beneficence is a concept in research ethics that states that researchers should have the welfare of the research participant as a goal in any clinical trial or other research study. In public health, beneficence implies acting in the best interest of the population or society as a whole.

Medicines almost always carry risks as well as benefits, so practising beneficence in clinical trials is not straight forward. An analysis of the risks as well as the benefits is required in each case.

Benefit

Benefit is a positive outcome (such as the relief of symptoms, cure, or prevention) from using a treatment or taking part in a study. The benefits of taking part in research may include helping others by participating in medical research, close monitoring by health professionals and experts, or getting access to an effective treatment before it is made available to the wider patient population.

Benefit-risk assessment

In medicines R&ampD, 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 factors like the nature and severity of the condition the medicine is intended to treat or prevent.

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

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.

Biotransformation

Biotransformation is the process whereby a substance is changed (transformed) from one chemical to another by a chemical reaction within the body. Biotransformation is vital to survival because absorbed nutrients (food, oxygen, etc.) are transformed into substances required for normal body functions. For some pharmaceuticals, it is a metabolite that is therapeutic and not the active pharmaceutical ingredient of a medicine itself.

Blinding

Blinding is a way of making sure that the people involved in a research study, such as the participants in clinical trials, do not know which trial arm they are assigned to. For example, in a trial with one treatment arm and one placebo arm, blinding means that the participants do not know if they are receiving the treatment or the placebo.

Blinding is used to remove bias that can be caused intentionally or unintentionally if participants or the research team are aware of which trial group participants are in.

Sometimes the term 'single-blind' is used to describe studies where the participants are unaware of which arm they are in, but the research team does know. In a double-blind trial, both the research team and participants do not know which participant is assigned to which arm.

A blind trial is the opposite of an open or open-label trial.

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 by a company or several companies may make the same generic medicine, to which each company gives its own brand name.

Budget impact

Costs within a particular timeframe and related to a particular healthcare budget rather than a country™s overall budget. This assumes robust data on epidemiology and treatment patterns, along with assumptions of uptake and displacement of current treatments.

Bulgarian Drug Agency


Bundesamt für Sicherheit im Gesundheitswesen


Bundesinstitut für Arzneimittel und Medizinprodukte



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