Reference:ICH ICH E2F Guideline 2010 1
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Document Information
| Document information | |
|---|---|
| Reference | ICH ICH E2F Guideline 2010 |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E2F Guideline |
| Version / Revision | 2010 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | DEVELOPMENT SAFETY UPDATE REPORT |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
Reference Details
| Scope | G |
|---|---|
| Document part | 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | DSUR: purpose and intended use as periodic safety report |
Text
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions [âŚ]
1.2 Objectives The main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed [...]
