Estimating the “First in human” dose – a revisit with particular emphases in oncology drugs

Abstract

The initial dose selection is one of the important steps for any investigative new drug (IND) entering the first clinical study in human. In this mini review, we will discuss the no observed adverse effect level (NOAEL) and the minimum anticipated biological effect level (MABEL) approaches for the estimations of first in human (FIH) dose. Particular attention will be placed on the development of FIH dose for oncology drugs.