An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks (quality, safety, or efficacy) of the medicinal product for

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

An estimated gain for an individual or a population.

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

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

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. Source: FDA

[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