Journal of Toxicologic Pathology
Online ISSN : 1881-915X
Print ISSN : 0914-9198
ISSN-L : 0914-9198
Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND)
Atsushi WATANABEOsamu KUSUOKANorihiro SATOOsamu NAKAZONOMichael WASKODaniel POTENTADai NAKAEHirofumi HATAKEYAMAHijiri IWATAMisaki NAOTATakayuki ANZAI
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JOURNALS FREE ACCESS Advance online publication

Article ID: 2017-0019

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Abstract

The Standard for Exchange of Nonclinical Data (SEND), introduced by the US Food and Drug Administration (FDA), is a scheme for the computerization, electronic application, and screening of preclinical data. Since its establishment, related organizations have been working together to implement SEND. However, it is difficult for individual pharmaceutical companies that often outsource to achieve complete compliance with SEND; hence, the cooperation of contract research organizations (CROs) and SEND Registered Solution Providers (RSPs) is indispensable. In SEND, most data, including those on pathology findings, are converted into controlled terminology (CT), but it is not a simple process to convert findings or levels of severity in the field of pathology, which is a descriptive science. The authors have successfully completed an FDA trial submission for a toxicology test conducted at a CRO and in doing so acquired important knowledge. This article presents a clear picture of such important knowledge from a pathologist's viewpoint.

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© 2017 The Japanese Society of Toxicologic Pathology
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