Bridging Study

Bridging Study designates a clinical or analytical study conducted to establish relevance of existing data from a source population or formulation to a new population, region, formulation, or dose, enabling regulatory agencies in new markets to accept foreign clinical data or confirming that changes to products do not affect safety or efficacy conclusions.

The pharmaceutical industry conducts bridging studies across diverse regulatory and development contexts. Regional bridging studies evaluate whether ethnic or demographic differences in new markets require different dosing or raise unique safety concerns, enabling ICH E5-guided extrapolation of foreign efficacy data with targeted bridging. Paediatric bridging studies extrapolate adult efficacy to children when disease course and drug response are sufficiently similar, supporting paediatric development programmes. Formulation bridging studies demonstrate pharmacokinetic equivalence between different formulations manufactured at different sites or scales. Biosimilar analytical bridging confirms comparability following manufacturing changes. Effective bridging reduces redundant clinical testing while ensuring appropriate characterisation of relevant populations.