Concepts of the Craft
Concepts of the Craft are a collection of documents that provide a high-level overview of a specific concept in the field of pharmacometrics. They are intended to be a quick reference. Each concept includes information on the definition, use cases, and implementation details for the concept.
Important considerations
Impact of a model
- 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