摘要
食物因素是影响药物暴露水平重要的原因之一,说明书作为控制用药风险的重要工具必须指定口服给药时的胃肠道状态(空腹/餐后)。监管当局鼓励肿瘤药采用创新的复杂高效试验设计,相比非肿瘤药而言,肿瘤药的食物影响研究有其特殊之处,而目前各监管机构的相关指导原则对于肿瘤药物没有特别说明。本文对2011~2019年美国食品药品监督管理局(FDA)上市的口服肿瘤药物食物影响临床研究进行了梳理,并以奥西替尼与泊马度胺为案例,从食物影响的处方依赖性与剂量依赖性角度探讨了食物影响研究的策略及路径,以期为中国肿瘤药物食物影响研究提供借鉴。
Food is one of the most important factors influencing drug exposure.As an important tool to control the risk of medication,drug instructions must specify the gastrointestinal tract status(fasting/fed)when drugs are administered orally.Regulatory authorities encourage oncology drugs to adopt innovative complex and efficient experimental designs,so compared with non-oncology drugs,food-drug interaction studies of oncology drugs are unique.But at present,the related guidelines doesn’t specifically explain studies of oncology drugs.This paper reviews the clinical research on the effects of oral tumor drugs marketed by the Food and Drug Administration(FDA)from 2011 to 2019.Taking oxitinib and pomalidomide as cases,this paper discusses the strategies and paths of food effects studies from the perspective of the formulation-dependency and dose-dependency.To provide lessons and experimence for the studies of food-drug interaction on anti-cancer drugs in China.
作者
李文萍
张贤
李文倩
白戎彪
毕福林
杨劲
LI Wen-ping;ZHANG Xian;LI Wen-qian;BAI Rong-biao;BI Fu-lin;YANG Jin(College of Pharmacy,China Pharmaceutical University,Nanjing 210009,Jiangsu Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2020年第13期1894-1897,共4页
The Chinese Journal of Clinical Pharmacology
基金
中国药科大学“双一流”建设基金资助项目(CPU2018GY24)。
