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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...
Autores principales: | Anzai, Takayuki, Kaminishi, Masamichi, Sato, Keizo, Kaufman, Laura, Iwata, Hijiri, Nakae, Dai |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Japanese Society of Toxicologic Pathology
2015
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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 |
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