Meals in fast and fed studies [Regulatives / Guidelines]
We need to put clear criteria for meal consumption in BE studies, specifically, meals in fasting studies and meals (besides the high fat breakfast) in fed studies? Subjects are dosed and then 4-5hrs later they're provided lunch, later perhaps a snack, dinner, etc. Depending on the Tmax of the drug, the meal after 4hrs from the dose could affect absorption. Subjects have a variety of food requirements; A tall man might require more food than a small man. Should subjects "be made" to eat 100% of their meal (for consistency between subjects) or is it fine for them to eat 75% or even less? How about later meals after 2xTmax? They won't affect absorption, so could subjects eat as much or as little as they want? Do we care about any meal but the high fat breakfast in fed studies?
looking forward to hear from you