Establishment of the Global SEND Alliance (G-SEND) in Japan and efficient creation of electronic SEND datasets between CROs

Anzai, T; Matsuyama, T; Wasko, M; Hatakeyama, H; Horikawa, S; Anzai, R; Iwata, H; Imai, N; Mizuhashi, F; Tsuboi, M; Okuzono, T; Takagi, H; Cho, H; Rong, BTS; Masaki, F; Nakae, D

Anzai, T (reprint author), Showa Univ, Sch Med, Shinagawa Ku, 1-5-8 Hatanodai, Tokyo 1420064, Japan.; Nakae, D (reprint author), Tokyo Univ Agr, Fac Appl Biosci, Dept Nutr Sci & Food Safety, Setagaya Ku, 1-1-1 Sakura Ga Oka, Tokyo 1568502, Japan.

JOURNAL OF TOXICOLOGIC PATHOLOGY, 2019; 32 (2): 119

Abstract

The Standard for Exchange of Nonclinical Data (SEND), adopted by the US Food and Drug Administration (FDA), is a set of regulations for digitalization......

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