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Abstract:
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Historically the F (Figures) in TFL terminology for the submission dossiers include more traditional visuals, e.g., bar graphs, K-M plots, line plots, scatter plots, waterfall plots. Several new visualization tools that are available now provide a unique way of exploring the data especially when it comes to understanding safety and efficacy in subgroups and permutations. With the appropriate upfront planning and execution, the review of a dossier can be expedited by including the visuals that are generated by these visualization tools into the dossier so that they are available to the regulatory agency for their further assessment. It is time for all of us to be more flexible and consider novel ways to prepare, submit and seek regulatory opinion for ensuring safe and effective treatments are made available to the patients in an expedited manner. As the technology component grows exponentially and data collection become much more comprehensive and fast, the utilization of data visualization tools will need to play much more dominant role in submission, approval and post marketing phases of the drug development.
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