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®SCS Capabilities — Bridging Strategies
The adoption of the International Conference on Harmonization guidance (ICHE5) on the use of foreign clinical data has enabled data collected in United States and European studies to be used in Japan for new drug approvals. The guidance discusses general criteria for acceptance, such as evidence of similar safety and efficacy in both regions.
Pharsight® provides strategies for bridging between different regions and assesses the likelihood of success. Each strategy depends on the nature of the difference between the two regions, which may be no difference, or differences in exposure-response or dose-response, regimen, or adverse event profile.
Successful bridging strategies permit earlier launch in the target region and higher global sales.