Table I.

Potential Applications of Absorption Modeling to Assess Effect of API Properties on Bioavailability Throughout Clinical Formulation Development

Pre-FIM formulation development efforts	Post-FIM formulation development efforts
Selection of API phase to enable FIM studies	Assess API particle size reduction or API phase change as means to improve bioperformance in response to human data (e.g., address food effect, enable fast T max, etc.)
Assess need for API particle size reduction for FIM studies	Assess impact of changes of API properties as a result of different synthesis or crystallization process across different API bulk lots
	Set specifications around API particle size
	Assess impact of changes in API phase or polymorph during manufacturing, scale up or on stability
	Assess impact of API phase/API properties on bioperformance for special populations (e.g., achlorhydric patients)