Label Extension
[505(b)(2) Strategy]

Case Study

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Label extension to more flexible dosing regimen

Goal: IV and once weekly SC administration registered. Extension of label to flexible SC regimen desired

Available data

  • Response from health authorities that previously conducted analysis did not support the claim for flexible dosing
  • Previously submitted modeling and simulation report
  • Plasma concentration measurements from bioequivalence study in healthy volunteers (IV and SC crossover)


  • Given information available, do you believe that a label extension is possible with a re-analysis of the data?
  • What approach would you take?


  • Systematic dose/exposure characterization of IV and SC data jointly
  • Development of a trust-worthy population PK model in the population of interest

Benefit for the Client

  • Successful label extension to more flexible SC dosing regimens

R based PK/PD modeling workflow

We helped a client leverage the power of open-source modeling tools for internal modeling and simulation tasks

Reproducible Analyses

Computation without Borders and Reproducible Analyses: IQ Desktop

Phase IIb Design

Confident transition to full development