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B

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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