Microdosing of protein drugs

Poor pharmacokinetics can limit a drug's clinical usefulness. Microdosing—giving a tiny dose to predict how a full dose will behave—has worked well for small-molecule drugs, despite early doubts. This paper reports the first successful clinical microdose of a humanized recombinant protein, raising the question of how broadly this approach will succeed for protein-based drugs.

Study at a glance

Abstract

Poor pharmacokinetics (PK) can seriously limit clinical utility. Knowing early whether a new compound is likely to have the desired PK profile at therapeutic doses is therefore important. One approach, microdosing,has shown high success with small molecular weight compounds,despite early skepticism. Vlaminget al.report the first, and successful, clinical application of a microdose of a humanized recombinant protein. But what is the likely success for this class of drugs more generally?