Clinical Trial Modernization: Technological, Operational, and Regulatory Advances
暫譯: 臨床試驗現代化：技術、運營與法規的進展

隨著製藥行業在這個技術創新新時代中前進，人工智慧（AI）、大數據和先進分析技術在臨床試驗中的整合具有巨大的潛力，可以改變藥物開發。《臨床試驗現代化：技術、操作和法規的進展》提供了對現代化臨床試驗的當前趨勢、挑戰和機會的全面概述，為這個不斷發展的領域的利益相關者提供了一條路線圖。本書是專業人士、研究人員和監管機構的寶貴資源，提供了可行的見解，幫助了解臨床試驗的未來及其在更快、更有效地將新療法推向市場中的關鍵角色。

Harry Yang, Ph.D., is Vice President of Biometrics at Recursion Pharmaceuticals. With over 25 years of experience in small molecule, biologics, and cellular immunotherapy development, his expertise spans the therapeutics areas of transplantation, vaccines, autoimmune and inflammatory disease, rare disease, and oncology. Dr. Yang is well-versed in innovative clinical trial design, regulatory submissions, and integration of real-world data, AI, and machine learning in drug R&D. He is a prolific author, having published 9 books and over 130 articles and book chapters covering critical statistical, scientific, and regulatory topics in drug R&D.

Liang Zhao, Ph.D., is Professor of Bioengineering and Therapeutic Sciences at University of California, San Francisco, following his role as the Director of Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Dr. Zhao has introduced a broad array of innovative tools in drug deliveries, bioequivalence assessment, and pharmacometrics. He has published 100+ articles and book chapters and is the recipient of the 2023 Gary Neil Prive for Innovation in Drug Development from ASCPT.

楊博士 (Harry Yang) 是 Recursion Pharmaceuticals 的生物識別技術副總裁。他在小分子、生物製劑和細胞免疫療法開發方面擁有超過 25 年的經驗，專長涵蓋移植、疫苗、自體免疫和炎症疾病、罕見疾病以及腫瘤學等治療領域。楊博士精通創新的臨床試驗設計、法規提交，以及在藥物研發中整合真實世界數據、人工智慧和機器學習。他是一位多產的作者，已出版 9 本書籍和超過 130 篇文章及書章，涵蓋藥物研發中的關鍵統計、科學和法規主題。

趙亮 (Liang Zhao) 博士是加州大學舊金山分校生物工程與治療科學的教授，曾擔任 CDER/FDA 通用藥物辦公室研究與標準辦公室的定量方法與建模部門 (DQMM) 的主任。趙博士在藥物傳遞、生物等效性評估和藥物計量學方面引入了多種創新工具。他已發表超過 100 篇文章和書章，並獲得 2023 年 ASCPT 藥物開發創新 Gary Neil Prive 獎。