A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group-Reference-Cited by-同舟云学术

A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group

Published:2021-07-19 Issue:6 Volume:55 Page:1214-1219
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Buchanan James^ORCID,Li Mengchun^ORCID,Ni Xiao^ORCID,Wildfire Jeremy^ORCID

Abstract

AbstractTechniques to evaluate large amounts of safety data continue to evolve based on a greater understanding of how the brain processes visual information and the advancement of programing tools. The Interactive Safety Graphics Task Force of the American Statistical Association Biopharmaceutical Safety Working Group has assembled a multidisciplinary team of experts in a variety of domains to develop the next generation of open-source visual analytical tools for safety data based on these advances. The multidisciplinary approach resulted in the rapid development of the first tool, a novel interactive version of the familiar Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) graphic along with a unique clinical workflow to guide the reviewer through the data analysis. This now serves as the model for the team to expand the open-source platform into a suite of other interactive safety analysis tools.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1007/s43441-021-00319-3.pdf

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