Topic：Drug Development- From Preclinical to Clinical 藥物研發-從臨床前到臨床研究
Speaker：陳巧文（財團法人生物技術開發中心 藥物平台技術研究所所長）
Time：June 5, 2023 12:30-2:00 pm
Venue：醫學院第四講堂 Lecture Hall Ⅳ at College of Medicine
Abstract：
Drug development encompasses discovery and development processes. Drug discovery is how new medicines are discovered and the process includes target identification/validation, hit to lead, lead optimization, candidate drug selection. Drug development stage includes preclinical and clinical phases. My presentation will cover all aspects of drug development from preclinical to clinical phase, and explain how preclinical development links drug discovery to initiation of human clinical trials. I will provide case studies and examples to explain how to identify potential target organs for adverse effects, define the therapeutic index to set the clinical initial staring doses, evaluate anticipated human risks, and provide guidance to the clinical investigators.