药物研发

药物研发是指一旦通过药物发现英语Drug discovery确定了先导化合物,就将一种新的药物推向市场的过程。具體步驟包括对微生物和动物的临床前研究英语Preclinical development,申请监管機構批准(例如獲得美国食品药品监督管理局批准)後即可為研究性新药英语Investigational New Drug启动人体临床试验,之後监管部门批准新药申请英语New Drug Application,這些流程都通過後,药物才能推向市场[1][2]

Drug discovery cycle schematic

参考文献编辑

  1. ^ Taylor, David. The Pharmaceutical Industry and the Future of Drug Development. Issues in Environmental Science and Technology (Royal Society of Chemistry). 2015: 1–33. ISBN 978-1-78262-189-8. doi:10.1039/9781782622345-00001 (英语). 
  2. ^ Strovel, Jeffrey; Sittampalam, Sitta; Coussens, Nathan P.; Hughes, Michael; Inglese, James; Kurtz, Andrew; Andalibi, Ali; Patton, Lavonne; Austin, Chris. https://www.ncbi.nlm.nih.gov/books/NBK92015/ |chapterurl=缺少标题 (帮助). Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies. Eli Lilly & Company and the National Center for Advancing Translational Sciences. July 1, 2016. PMID 22553881. 

外部链接编辑