Category: B

Benefit-Risk Assessments

Analysis of the favorable (beneficial) and unfavorable results of doing specific actions. Also called “benefit-harm” or “effectiveness-risk” analysis

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Blinding / Masking

A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which

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The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance

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Biologic Product

[FDA] FDA: A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the

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