One small step in time, one giant leap for DMPK kind – a CRO perspective of the evolving core discipline of drug development

Abstract

1. As the Space Race or Formula 1 drives innovation, efficiency and progress in home technology and home car markets, Drug Metabolism and Pharmacokinetics (DMPK) drives scientific innovation and value for drug development companies. Stand still and fall behind as the saying goes, and these analogies are true as much in the design and conduct of DMPK studies as they are in the technology and manufacturing sectors.

2. This short review showcases the impact that DMPK has had on drug development and how it has changed in the last 10 years, illustrating the value added scientific benefit, cost and time saving, that innovative DMPK program design and study conduct have. Examples and case studies spanning novel in vitro alternatives such as organ-on-a-chip (OOAC) developments; use of in vivo microsampling across small and large animal species; challenging historical paradigms in Absorption, Distribution, Metabolism and Excretion (ADME) studies; and embracing new technologies to address regulatory concerns, are presented.

3. The continual pace of change has kept DMPK at the core of pharmaceutical, crop and chemical evaluation, and this is set to continue as regulators use this discipline to inform decision-making. With new modalities and new scientific questions, DMPK will continue to evolve, with the likes of new in vitro, in vivo and in silico models becoming central to candidate selection and progression.

Keywords:

• DMPK
• drug development
• future perspective
• innovation
• regulators

Disclosure statement

The authors report no conflict of interest