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Articles and Publications

 

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Responses to the Standard for Exchange of Nonclinical Data (SEND) in Non-US Countries

Authors: Takayuki Anzai, Masamichi Kaminishi, Keizo Sato, Laura Kaufman, Hijiri Iwata, and Dai Nakae
Published: March 31, 2015
Location: Journal of Toxicologic Pathology 
In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs need a model for task allocation. This is being undertaken by the pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved.

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Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND)

Authors: Atsushi Watanabe, Osamu Kusuoka, Norihiro Sato, Osamu Nakazono, Michael Wasko, Daniel Potenta, Dai Nakae, Hirofumi Hatakeyama, Hijiri Iwata, Misaki Naota, and Takayuki Anzai
Published: July 31, 2017 
Location: Journal of Toxicologic Pathology 
The Standard for Exchange of Nonclinical Data (SEND) 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. 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.

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