Food effect study

Food effect bioavailability studies are crucial to understand how food consumption affects a drug’s absorption into the bloodstream. These studies, typically conducted for new drugs, evaluate the impact of food on the rate and extent of drug absorption when taken shortly after a meal (fed state) compared to taking it on an empty stomach (fasted state). 

Assessing the effect of food on drugs in INDs and NDAs – clinical pharmacology considerations (FDA, 2022)