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August 12, 2009

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Mike Harwood

You have a comprehensive list of data standards for toxicology data in your preentation. I notice that SEND is missing. This is the standard being developed by CDISC for electronic submission to FDA and that is attractig considerable interest and effort from a wide range of (principally) US organisations. It is currently the subject of a pilot project with FDA.
You may want to take a look at it as it will deliver both data interchange format standardisation and controlled terminology across regulatory submissions for preclinical toxicology. http://www.fda.gov/ForIndustry/DataStandards/CDISCDataStandards/ucm155320.htm

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