浅析人工智能/机器学习用于药品开发——基于FDA讨论文件的探讨  

Analysis of the Application of Artificial Intelligence/Machine Learning in Drug Development:Based on FDA Discussion Paper

作　　者：姚立新 YAO Li-xin(NMPA Institute of Medical Economics)

机构地区：[1]国家药品监督管理局南方医药经济研究所

出　　处：《中国食品药品监管》2023年第7期44-57,共14页China Food & Drug Administration Magazine

摘　　要：人工智能/机器学习(AI/ML)用于医药产品临床前、临床开发、生产、上市后监测,有望对医药产品开发和使用带来深刻影响,同时对制药行业和药品监管带来机遇和挑战。为促进相关领域的监管工作,2023年5月FDA发布《人工智能和机器学习用于药品与生物制品开发的讨论文件》。本文通过对讨论文件的探讨,概述了AI/ML在药品开发过程中的运用现状和潜在用途,以及FDA运用AI/ML的经验,并介绍了在药品开发过程中运用AI/ML的考量因素,旨在推动创新技术在医药产品领域的运用,挖掘更多潜在效能。The application of artificial intelligence/machine learning(AI/ML)in preclinical,clinical development,manufacturing,and post-marketing surveillance of pharmaceutical products and devices is expected to have a profound impact on drug product development and use,while also posing challenges to the pharmaceutical industry and regulatory bodies.In order to promote regulatory work in related areas,the FDA released the Using Artificial Intelligence&Machine Learning in the Development of Drug&Biological Products:Discussion Paper and Request for Feedback in May 2023.This paper provides an overview of the current status and potential uses of AI/ML in drug development from the perspective of the discussion paper.It also highlights the experience of FDA in using AI/ML and introduces the considerations for using AI/ML in drug development,aiming to promote the application of innovative technologies in the pharmaceutical products field and explore its potential efficacy further.

关 键 词：人工智能 机器学习 医药产品 开发 

分 类 号：R95[医药卫生—药学]