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Learnings from the First R-Based Submission to FDA by Novo Nordisk
Jan. 4, 2024, 4:52 p.m. | Ismael Rodriguez
R-bloggers www.r-bloggers.com
Novo Nordisk stands as a trailblazer in R-based submissions to the FDA, having recently completed the inaugural submission in this statistical programming language to regulatory authorities. This milestone was achieved at the close of 2021, encompassing the inclusion of SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets, programs, ...
Continue reading: Learnings from the First R-Based Submission to FDA by Novo Nordisk
adam analysis data data model fda inclusion language programming programming language r bloggers regulatory statistical study
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