The situation
A dose worked in Phase II. At filing it has to be shown to be the right dose, including for patients at the edges of the distribution.
What we do
- Model exposure and the covariates that genuinely explain it
- Link exposure to efficacy and to safety
- Test the alternatives you did not choose
What you get
- Submission-ready popPK and exposure-response reports
- Dose justification, and the evidence behind the label
- Answers to the dosing questions a reviewer will raise
Regulatory basis
Dose justification is a recurring cause of regulatory questions and post-marketing commitments. Planned prospectively, the analysis answers them before they are asked.