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

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.

由斯坦福大學SPARK計劃的創始人撰寫，這本書是一本實用指南，針對學術研究機構的教授、學生和臨床醫生，旨在幫助他們了解藥物開發過程，以及如何將他們的發現轉化為未來的新藥。通常，許多具有潛力的基礎科學發現因為被認為「太早」而未被追求，無法吸引業界的興趣。學術研究人員可以進行簡單且相對低成本的工作，以推進他們的研究成果，使其能夠在臨床上進行測試或吸引更多業界的興趣。每一章節廣泛討論藥物開發中的重要主題，從前臨床工作中的測試設計到臨床試驗設計、監管問題和市場評估。在提供實用概述後，鼓勵讀者參考特定主題的更詳細的文獻資料。