A Practical Guide to Drug Development in Academia: The SPARK Approach

Daria Mochly-Rosen, Kevin Grimes (eds)

  • PublishedJuly, 2022
  • Binding平裝 / 23.5*15.8 / 232pages / 單色(黑) / 中文
  • Publisher國立臺灣大學出版中心
  • SeriesEducation-Textbooks
  • ISBN978-986-350-593-8
  • GPN1011100413
  • Price NT$600
  • ebook
    KOBO / Readmoo / TAAZE / books.com.tw /
  • Paper Books San Min Books / wunan / books.com.tw / National Books / iRead / eslite / TAAZE /
  • EISBN(PDF)978-986-350-663-8
  • EISBN(EPub)978-986-350-662-1

Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed “too early” to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest.

Daria Mochly-Rosen is the George D. Smith Professor of Translational Medicine, the Senior Associate Dean for Research, and a Professor in the Department of Chemical and Systems Biology at Stanford University School of Medicine and the Co-director of SPARK.
Kevin Grimes is the Co-director of the SPARK Translational Research Program and a Professor in the Department of Chemical and Systems Biology at Stanford University.
Yu-Feng Tseng
Professor & Associate Chairman, Department of Computer Science and Information Engineering, Graduate Institute of Networking and Multimedia, National Taiwan University
Director, Drug Research Center, College of Medicine, National Taiwan University

前言/Daria Mochly-Rosen
繁體中文版序/Daria Mochly-Rosen
關於SPARK Taiwan計畫

第1章 啟程 Getting Started
  1.1 如何將學界新療法推至臨床階段
  1.2 新藥發現與開發概論
  1.3 臨床需求評估
  1.4 目標產品規格
  1.5 專案管理和專案規劃
第2章 新藥開發與臨床前工作 Discovery and Preclinical Work
  2.1 有效規劃臨床前工作項目
  2.2 老藥新用
  2.3 HTS檢測發展
  2.4 藥物化學跟先導化合物優化
  2.5 疫苗開發
  2.6 開始動物研究的時機
  2.7 體內藥理學:藥物開發中的多種作用
  2.8 藥物動力學和ADME特性
  2.9 給藥途徑和劑型
  2.10 臨床前安全性研究
第3章 邁向臨床之路 Preparing for the Clinic
  3.1 藥品開發法規考量
  3.2 製造與品質控管
  3.3 生物製劑技術與製造
  3.4 臨床試驗設計
  3.5 臨床試驗概論
第4章 技術移轉 Transferring Technology
  4.1 智慧財產權
  4.2 與大學技術轉移單位合作
  4.3 利益衝突迴避
  4.4 法令遵循諮商
第5章 商業化與新創事業 Commercialization and Entrepreneurship
  5.1 藥品市場選擇
  5.2 商業評估
  5.3 新創招商簡報術
  5.4 創投募資
  5.5 非營利藥物開發
  5.6 生技新創法務
  5.7 創辦人特別股
  5.8 規劃、組織、激勵和管控
第6章 總結 Concluding Thoughts
  6.1 行動呼籲:藥品開發變革