Stage 2: Define the Context of Use (CoU)

In accordance with previous ICH, FDA and ISO guidance (ICH Q8(R2), Q12; ISO 22989; FDA, 2025; FDA-EMA, 2026), the Context of Use is defined as a precise description of how the model will be used to address the QoI, including the role of the model in decision-making. This Stage distinguishes between exploratory, supportive, or decision-critical applications and is central to determining the level of regulatory scrutiny.

Stage 2a: Model Type Decision

In accordance with guidance from the EMA (EMA, 2024), the model approach should be selected.