以患者为中心的临床药理学与MID3框架整合推进免疫炎症疾病生物制剂开发
Integrating Patient‐Centric Clinical Pharmacology and MID3 to Advance Biologic Development in Immune‐Mediated Inflammatory Diseases
作者：Sihem Ait‐Oudhia、Li Zhang、Dipak S. Pisal、Brian Cicali
单位：Quantitative Pharmacology and Pharmacometrics (QP2), Merck & Co., Inc, Rahway, New Jersey, USA.；Quantitative Clinical Pharmacology, Daiichi Sankyo, Basking Ridge, New Jersey, USA.；Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, 20993, USA.；Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.
摘要
《Clinical Pharmacology & Therapeutics》发表观点文章，探讨将患者中心理念与MID3（Measure of Influence on Disease trajectory）框架整合至免疫介导炎症疾病生物制剂开发的全流程，强调在剂量选择、终点指标设计及临床开发策略中纳入患者报告结局（PRO），以提升药物研发效率与注册转化价值。
AI 主编 · 推荐理由推荐理由
本文为免疫炎症领域生物药临床研发提供方法论参考，尤其适用于开展剂量探索及终点指标选择的团队。建议在生物类似药或改良型新药立项阶段即引入患者中心视角，提前布局PRO数据采集策略。