Pharmacometrics in Post Approval: Fulfillment of Requirements, Label Extension, and Life-Cycle Management

Authors: Jones A
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), PDUFA VI, Pharmacometric, Post-Approval/Generics, SLP MIDD+ Virtual Conference, SLP2021MIDD
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Aksana Jones, Associate Director, walks you through unleashing the full potential of model-informed drug development (MIDD) post-approval.​

MIDD acknowledgment in the PDUFA VI authorization provides an excellent opportunity for industry and regulators to collaborate in further advancing the applications of MIDD and thus potentially changing drug development paradigms.

Topics covered:

  • Pediatric Dose Selection Challenge
  • The Pregnancy Dose Selection Challenge 
  • Model-Based Approaches Add Significant Value in Special Population Dose Selection ​
  • Label Extensions
  • Life-Cycle Management
  • and more!

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021