A Brief Review of the Clinical Pharmacology Expansion Cohorts in FIH Oncology Trials
作者单位：Department of Clinical PharmacologyBeiGene (Shanghai) Co.Ltd
会议名称：《2018年中国药理学会定量药理学专业委员会学术年会》
会议日期：2018年
学科分类：1007[医学-药学(可授医学、理学学位)] 1006[医学-中西医结合] 100706[医学-药理学] 100602[医学-中西医结合临床] 10[医学]
摘 要：Background The use of expansion cohorts in first-in-human(FIH) trials has become a seamless strategy for improving the efficiency of novel drug development especially in oncology therapeutic *** purpose of conducting these expansion cohorts can be assessing anti-tumor activity in a diseaseand/or population-specific setting,evaluating alternative doses or schedules,exploring potential biomarker and collecting clinical pharmacology information to optimize later phase dosing *** a new FDA draft guidance was published to emphasize the advantage of conducting multiple expansion cohorts in FIH trials drug development,with the goal of making highly effective drugs widely available to the public as quickly as possible