Co-administration of an orally administered drug with food can increase the systemic exposure of the drug,to have a significant impact on the safety and efficacy of orally administered drug products.Food-effect studies is very important in drug development.Food exerts its effects on the mechanisms of drug action and physiological environment of the body,to have a significant impact on the safety and efficacy of drugs,including the drug development process,post market clinical application of drugs,and patient compliance.The effect of food is different across meals with different fat or caloric contents.This article discusses orally administered drug products,combining drug development cases,according to relevant regulations and guidelines,starting from the approach of food-effect studies in drug development,to analyze the key role of food-effect studies in the drug development process,to elucidate the clinical pharmacology and food-effect characteristics,to clarify the actual usage and dosage,to provide reference for the design of food-effect studies in drug development.
关键词
食物影响研究/口服药物/药物研发案例/用法用量
Key words
food-effect study/oral drug/drug development cases/usage and dosage
维普
万方数据