Important considerations

Impact

  • What is the modeling used for? (e.g., bridging, dose, SmPC parameters?)
    • Does the aim align with the conclusion?
  • What data is available?
    • Rich data
    • Sparse data
  • What is the structural model?
    • Reasonable parameter estimates and RSE’s?
    • Graphical evaluation (VPC first)
    • Covariate evaluation
  • Exposure-response is generally non-informative if only one dose-level is given, even if weight-adjusted

Reviewing models

  • Does my conclusion align with the authors?
  • Questions NGN (eNGiNe)
  • Need-to-know: Will affect conclusion (Major objection)
  • Good-to-know: Could affect conclusion (Other concern)
  • Nice-to-know: Won’t affect conclusion (avoid asking this question)

References

  • Musuamba et al., 2021, https://doi.org/10.1002/psp4.12669
  • Skottheim Rusten & Musuamba, 2021, https://doi.org/10.1002/psp4.12708