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   Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions.


A drug not protected by a trademark. Also, the scientific name as opposed to the proprietary, brand name.

Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.

Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.


Professionals who are skilled in helping people make decisions about what is morally right and wrong.


Baseline assessment
Assessment of subjects as they enter a trial and before they receive any treatment.

Bayesian approaches (statistics)
Approaches to data analysis that provide a posterior probability distribution for some parameter (for example, treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference.

Beta error (statistics)
See Type 2 error.

Between-subject variation
In a parallel trial design, differences between subjects are used to assess treatment differences.

Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.


Application of statistics to biological and medical problems.

Blind review
The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalising the planned analysis.

Blinded medications
Products that appear identical in size, shape, colour, flavour, and other attributes to make it very difficult for subjects and investigators to determine which medication is being administered.

Blind study
One in which the subject or the investigator (or both) are unaware of what trial product a subject is taking. See also double-blind study, single-blind study, triple-blind study.

A procedure in which one or more parties to the trial are kept unaware of the treatment assignments. Single-blinding usually refers to the subject(s) being unaware, and doubleblinding usually refers to the subject(s), investigators, monitor, and, in some cases, data analyst(s) being unaware of the treatment assignments.

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