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[PubMed] [Google Scholar] 65.Sanyal AJ, Freedman AM, Luketic VA, Purdum PP 3rd, Shiffman ML, DeMeo J, Cole PE, Tisnado J

the Basic Science Project of Henan Eye Institute/Henan Eye Hospital (grant numbers: 22JCQN004 and 21JCZD001)

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The aim of this publication is to serve as a tutorial for conducting FIH trials for both small molecule and biological drug candidates with topics covering regulatory requirements, preclinical safety testing, study design considerations, safety monitoring, biomarker assessment, and global considerations