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QbD at Vertex: Back to the Future

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    Individuals

    AIChE Member Credits 0.5
    AIChE Members $19.00
    AIChE Graduate Student Members Free
    AIChE Undergraduate Student Members Free
    Non-Members $29.00
  • Type:
    Conference Presentation
  • Conference Type:
    AIChE Annual Meeting
  • Presentation Date:
    November 20, 2020
  • Duration:
    12 minutes
  • Skill Level:
    Intermediate
  • PDHs:
    0.20

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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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Checkout

Checkout

Do you already own this?

Pricing


Individuals

AIChE Member Credits 0.5
AIChE Members $19.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $29.00
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