Ethnobridging studies
Ethnobridging studies are one of many clinical development services Pharmaron offers to our global customers. Ethnobridging studies can shorten the overall timelines for certain global drug development programs and are key for successful international regulatory submissions. Pharmaron provide access to 1st generation Japanese subjects, with the network to recruit from a large ethnic population.
Benefits of undertaking ethnobridging studies
- Potential to reduce international drug development timelines by approximately 5 years
- Generate data in Japanese subjects during Phase I clinical trials in the US
- Provide sufficient data for Pharmaceuticals and Medical Devices Agency (PMDA) IND filings in Japan without the need for repeating clinical studies in that specific region
- Data acquisition from relevant ethnicities in early Phase I can improve planning for later stage Phase II and III clinical trials