The purpose of this page is to organize information about a prototype standard method for reporting stability data in electronic format using Extensible Markup Language (XML) and to provide a working model of a potential stability review tool.
This information was presented by Jon Clark, Chemist, ONDC, on May 22, 2001 at the Drug Information Association (DIA) "Data Standards for Clinical Development" meeting at the Washington Marriott Hotel.
Stability review tool working model (Zip file)
Introductory document and tutorial
Stability
Data File file specification.
Send questions to Jon Clark at CLARKJO@CDER.FDA.GOV
FDA/Center for Drug Evaluation and Research
Last Updated: June 22, 2001
Originator: OTCOM/DLIS
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