新药研发是一个跨学科、长周期、高风险的系统工程。按照美国食品药品监督管理局(FDA)的公开框架,完整流程可分为五大步:①发现与早期开发;②临床前研究;③临床研究;④FDA 药品审评;⑤上市后安全性监测。本文在参考 FDA 官方指导的基础上,结合 ICH ...
A plan for boosting the economy by hitting three major targets over three different time spans. Originally floated by the central government in 1987, the first step was to double the GDP of 1980 by ...