Covariate modeling in pharmacometrics: General points for consideration

JournalPharmacometricsRegulatory interactionsSpecial populationsTrial design and analysis

In this article, Jakob Ribbing and co-authors under the ISoP Standards & Best Practice Committee, present perspectives on best practices for covariate analyses, aiming to guide pharmacometrics decision making.

With an abundance of sources to learn from, the need for a summary was identified. Through covering several aspects of covariate analysis that are common to (nearly) all approaches outlined, along with recommendations for what approaches and tools to use in different modeling applications, an overview with generic points of consideration is presented. This can support in the planning, execution, reporting and interpreting covariate analysis whether you operate in industry, academia or regulatory.