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San Diego Convention Center

2019年6月23日 (日) 午後 2:30 - 2019年6月27日 (木) 午後 6:00

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2019 Global Annual Meeting

Join thousands of your peers at the life sciences event of the year!

Modernizing Data Review in Drug Development with R Shiny

Session Chair(s)

Susan  Mayo, MS

Susan Mayo, MS

Senior Mathematical Statistician, CDER Office of Biostatistics

FDA, United States

ASA Biopharm/DIA Safety Working Group, safety clinicians, statisticians and data scientists, developed an R Shiny tool available for all, initially for detection and review of hepatotoxicity. Discuss this new tool and seek input on next steps and support.

Learning Objective : Describe an R Shiny safety tool developed by the Interactive Safety Graphics taskforce of the ASA Biopharm/DIA Safety Working Group, for review of liver function and Hy’s Law for use during drug development and submission review; Discuss audience feedback on path forward for this new model of agile software development and support, with consideration of compliance.

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