On the assessment of effects of food on the pharmacokinetics of drugs in early development.
The impact of food on the pharmacokinetics of a drug has important implications in drug development. This commentary is aimed at addressing two key challenges, developability of drugs whose pharmacokinetics are severely influenced by food, and the need for addressing the effects of fruit juice ingredients which modulate metabolic/efflux properties of a compound. Perspectives on the value in predicting food-drug interactions during preclinical development, timing of clinical food-drug interaction studies, and implications of food effects are presented herein.
Li
Zhihong
Z
Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA.
Vachharajani
Nimish N
NN
Krishna
Rajesh
R
D000818:Animals; D001189:Aryl Hydrocarbon Hydroxylases; D001628:Beverages; D001682:Biological Availability; D002957:Citrus; D051544:Cytochrome P-450 CYP3A; D065607:Cytochrome P-450 Enzyme Inhibitors; D003577:Cytochrome P-450 Enzyme System / Q000378:metabolism; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics; D004032:Diet; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D005502:Food; D018565:Food-Drug Interactions; D006801:Humans; D010089:Oxidoreductases, N-Demethylating / Q000037:antagonists & inhibitors / Q000378:metabolism; D010599:Pharmacokinetics
D065607:Cytochrome P-450 Enzyme Inhibitors; D003692:Delayed-Action Preparations; D003577:Cytochrome P-450 Enzyme System; D001189:Aryl Hydrocarbon Hydroxylases; D051544:Cytochrome P-450 CYP3A; D010089:Oxidoreductases, N-Demethylating