Assessing the performance of QSP models: biology as the driver for validation.

Validation of a quantitative model is a critical step in establishing confidence in the model's suitability for whatever analysis it was designed. While processes for validation are well-established in the statistical sciences, the field of quantitative systems pharmacology (QSP) has taken a more piecemeal approach to defining and demonstrating validation. Although classical statistical methods can be used in a QSP context, proper validation of a mechanistic systems model requires a more nuanced approach to what precisely is being validated, and what role said validation plays in the larger context of the analysis.