Labcorp Early Development Laboratories Inc, Harrogate, United Kingdom.
Labcorp Early Development Laboratories Inc, Huntingdon, United Kingdom.
Xenobiotica. 2022 Aug;52(8):797-810. doi: 10.1080/00498254.2022.2124389.
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.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 alternatives such as organ-on-a-chip (OOAC) developments; use of 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.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 , and models becoming central to candidate selection and progression.
随着太空竞赛或一级方程式赛车推动家庭技术和家庭汽车市场的创新、效率和进步,药物代谢和药代动力学(DMPK)推动了药物开发公司的科学创新和价值。正如人们常说的那样,原地踏步就会落后,这些类比在 DMPK 研究的设计和实施中与技术和制造领域一样适用。这篇简短的综述展示了 DMPK 对药物开发的影响,以及它在过去 10 年中的变化,说明了创新的 DMPK 项目设计和研究实施带来的增值科学效益、成本和时间节省。本文涵盖了跨越新颖替代方案(如器官芯片(OOAC)的发展)的例子和案例研究;在小动物和大动物物种中使用微量采样;在吸收、分布、代谢和排泄(ADME)研究中挑战历史范例;以及采用新技术解决监管问题。不断变化的步伐使 DMPK 成为药物、作物和化学评估的核心,随着监管机构利用这一学科为决策提供信息,这种情况将继续下去。随着新的治疗方法和新的科学问题的出现,DMPK 将继续发展,新的 和 模型将成为候选药物选择和进展的核心。