Reference:ICH ICH E2F Guideline 2010 1: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E2F Guideline 2010 | ||
| | |module=5 | ||
| | |unit=5.3.3 | ||
| | |scope=G | ||
| | |doc_part=1 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00068-Dev-gsb ++ TAG-00317-Obj-set ++ TAG-00329-Saf-lne ++ TAG-00001-Med-rzn | |||
|tags_display=[[Glossary:TAG-00068-Dev-gsb|DSUR]], [[Glossary:TAG-00317-Obj-set|Objective]], [[Glossary:TAG-00329-Saf-lne|Safety]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]] | |||
|comment=DSUR: purpose and intended use as periodic safety report | |||
|content=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 […] | |||
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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 […] | |||
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 [...] | 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 [...] | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| 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 | |
|---|---|
| Module | Module 5 — Unit 5.3.3 |
| Scope | G |
| Document part | 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | DSUR, Objective, Safety, Medicinal product |
Content
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 […]
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 [...]
