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RegisterDevelopment Safety Update Report requirement [Regulatives / Guidelines]
Dear members,
A BE has been planned to be conducted in France. The BE study has a washout period of 30 days. The entire BE study will be completed within 50 days. Is a DSUR required for this study? I thought DSURs are required for study with active molecule whose study period extend beyond a year.Request the experts to guide please.
A BE has been planned to be conducted in France. The BE study has a washout period of 30 days. The entire BE study will be completed within 50 days. Is a DSUR required for this study? I thought DSURs are required for study with active molecule whose study period extend beyond a year.Request the experts to guide please.
Complete thread:
- Development Safety Update Report requirementTina 2013-09-12 14:20
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Ing. Helmut Schütz