定量药理学在疫苗研发中应用的概述与展望  

Application of quantitative pharmacology in vaccine research and development:overview and prospect

作　　者：马广立 张菁[2] MA Guangli;ZHANG Jing(Wuxi BioCity Biotechnology Co.,Ltd,Shanghai 200011,China;Phase I Clinical Research Center of Huashan Hospital Affiliated to Fudan University,Shanghai 200040,China)

机构地区：[1]无锡智康弘义生物科技有限公司,上海200011 [2]复旦大学附属华山医院Ⅰ期临床研究室,上海200040

出　　处：《中国临床药理学与治疗学》2023年第3期315-322,共8页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：本文从抗原提呈、佐剂、淋巴系统等方面介绍了疫苗的作用机制与产品特点,并总结了定量药理学的QSP、PK/PD、Dose-Response、MBMA等核心工具在疫苗研发的量效关系、临床前与临床转化、生物标记物与有效性相关性等研究中的关键应用。期待在药物研发中成功应用的模型引导药物开发理念能够在疫苗领域促成模型引导的疫苗研发,进而为更安全、有效、可控的疫苗产品研发做出其应有的贡献。This article introduces the mechanism including antigen presentation,adjuvant,lymphatic system and the characteristics of vaccine,and then summarizes the key applications of core pharmacometrics approaches including QSP,PK/PD,dose response analysis,MBMA,in dose-response,preclinical and clinical translation,and correlation between biomarkers and efficacy of vaccines.It is expected that the successful application of model informed drug development can promote model informed vaccine development so that pharmacometrics makes its due contributions to the development of safer,more effective and more controllable vaccine products.

关 键 词：疫苗 模型引导疫苗研发 模型引导药物研发 定量药理学 量效关系 定量系统药理学 基于模型的荟萃分析 

分 类 号：R311[医药卫生—基础医学]