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Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabu...

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Detalles Bibliográficos
Autores principales: Anzai, Takayuki, Kaminishi, Masamichi, Sato, Keizo, Kaufman, Laura, Iwata, Hijiri, Nakae, Dai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Japanese Society of Toxicologic Pathology 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444503/
https://www.ncbi.nlm.nih.gov/pubmed/26028814
http://dx.doi.org/10.1293/tox.2015-0007