药物研发

药物研发是指一旦通过药物发现确定了先导化合物,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,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启动人体临床试验,之後监管部门批准新药申请,這些流程都通過後,药物才能推向市场[1][2]

参考文献

  1. Taylor, David. . 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). . Eli Lilly & Company and the National Center for Advancing Translational Sciences. July 1, 2016. PMID 22553881.

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