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)

Questions

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

Approach

• 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