This talk focuses on the lessons learned in implementing the QbD approach in DS regulatory filings for the Vertex CF portfolio ranging from Kalydeco (2012) to Trikafta (2019). Case studies are used to address the evolution of approaches taken for risk assessments, experiment design and analysis, nonlinear modeling, design space limits and other areas. These lessons learned are fueling further development as we prepare for future regulatory filings. Further discussion during the panel forum will be welcome.
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