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Bridging Clinical Studies

Meaning

Bridging clinical studies are specialized, focused clinical trials designed to extrapolate the efficacy and safety data of a drug or treatment, typically already established in one population, to a new population or region. These studies are generally smaller than pivotal Phase III trials and focus on pharmacokinetic (PK) and pharmacodynamic (PD) parameters, alongside limited clinical efficacy data. The goal is to determine if intrinsic and extrinsic factors in the new population, such as genetic polymorphisms or differing clinical practices, necessitate changes to the established dosage or regimen. They are critical for regulatory approval in diverse global markets, minimizing redundant large-scale trials.