The Development Safety Update Report
| Autor: | Stewart Geary |
|---|---|
| Rok vydání: | 2010 |
| Předmět: | |
| Zdroj: | Pharmaceutical Medicine. 24:271-279 |
| ISSN: | 1179-1993 1178-2595 |
| Popis: | This article provides a critical review of the Step 2/3 International Conference on Harmonisation (ICH) E2F guidance on the Development Safety Update Report (DSUR) and examines its contents in relation to current requirements in the US and EU. The DSUR will provide a yearly update on the safety information for compounds in clinical development in addition to providing information on total exposure in the clinical trial programme, actions taken for managing safety risks and statements on the benefit-risk balance for clinical trials undertaken in the clinical development programme. The proposedDSURwill essentially cover all requirements of the existing periodic reports required during clinical development in the US and EU. The organization of the DSUR is similar to that of the postmarketing Periodic Safety Update Report but the DSUR will require additional fields and sources of data and it makes use of several region-specific appendices. Special attention is given in this article to challenges in implementing the DSUR concept including the varieties of data required, the amount of information from the DSUR to be provided to Ethics Committees and the impact of the incomplete international harmonization proposed by the ICH E2F guidance. |
| Databáze: | OpenAIRE |
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