Medical-Reference

In today’s economic environment, globalization of pharmaceutical products has been the key to success for drug manufacturers. Investors of newer drugs are hence requiring to do more at less cost and quick turnaround time. Consequently, they are facing newer challenges, as well. One of the biggest road blocks, nowadays, to globalize a product is the ethnic factor.

Since the pharmacodynamic or clinical data in the original patient population can significantly vary with the population in the new region, many regulatory authorities have limited their willingness to rely on foreign clinical data to approve a new compound. To overcome the issue, in recent years bridging studies have been a matter of critical importance for drug manufacturers developing a potential new drug.

Table of Contents What is a Bridging Study?History of Bridging StudyIntrinsic and Extrinsic Ethnic FactorsImportance of Bridging StudiesEvaluation ProcessEndnotesMedical Reference
What is a Bridging Study?
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