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Mandating Bridging Studies Under ICH E5 Regulatory Criteria
📢 DDReg Knowledge Capsule – Episode [25]
This podcast cover about ICH E5 guidelines mandate bridging studies when foreign clinical data cannot reliably predict a drug's safety or efficacy in a local population. Requirements depend on ethnic sensitivity, including intrinsic genetic factors, extrinsic medical practices, and PK/PD differences.
https://resource.ddregpharma.com/blogs/bridging-studies-mandatory-under-ich-e5/
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