Skip to main content

Bridging Studies

Meaning

Bridging studies are a specific type of clinical investigation used to extrapolate the efficacy and safety data of a pharmaceutical product, typically approved in one population or region, to a new population or region. These studies aim to confirm the applicability of the original clinical findings by assessing factors like pharmacokinetics, pharmacodynamics, and clinical response in the new target group. This approach provides a scientifically sound basis for regulatory approval without necessitating full-scale, repetitive clinical trials.