藥物研發
外觀
藥物研發是指一旦通過藥物發現確定了先導化合物,就將一種新的藥物推向市場的過程。具體步驟包括對微生物和動物的臨床前研究,申請監管機構批准(例如獲得美國食品藥品監督管理局批准)後即可為研究性新藥啟動人體臨床試驗,之後監管部門批准新藥申請,這些流程都通過後,藥物才能推向市場[1][2] 。
參考文獻
[編輯]- ^ Taylor, David. The Pharmaceutical Industry and the Future of Drug Development. Issues in Environmental Science and Technology (Royal Society of Chemistry). 2015: 1–33 [2020-11-13]. ISBN 978-1-78262-189-8. doi:10.1039/9781782622345-00001. (原始內容存檔於2021-04-28) (英語).
- ^ 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/
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缺少標題 (幫助). 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 [2020-11-13]. PMID 22553881. (原始內容存檔於2020-04-19).