Label extension to more flexible dosing regimen
Goal: IV and once weekly SC administration registered. Extension of label to flexible SC regimen desired
- 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