摘要
过程分析体系（PAT）正在迅速发展成为大批量药物生产中的程序性步骤。不过在临床试验的产品研发期小量样品生产中PAT的价值还没有得到广泛的承认。
Process analytical technology （PAT） is rapidly establishing itself as the procedural approach of choice in large-scale drug manufacture. What is less widely acknowledged is the value of PAT in producing small quantities of products in development during clinical trials.
