细胞治疗药物非临床药代动力学研究

摘要/Abstract

摘要： 细胞治疗作为新兴的治疗手段，在多种疾病尤其是难治性疾病中展现出巨大潜力。细胞治疗药物包括干细胞、免疫细胞以及其他终末分化细胞等，经体外操作或基因改造后，回输体内实现治疗效果。鉴于其独特的生物学特性，细胞治疗药物的药代动力学（Pharmacokinetics， PK）研究面临诸多挑战。本文系统综述了细胞治疗药物的PK特征，深入剖析现有法规框架与已上市药物的非临床PK试验设计及适用的生物分析方法，以期为细胞治疗药物的研发与评价流程提参考，促进该领域的发展与应用。

关键词: font-size:medium, ">细胞治疗；药代动力学；非临床研究；药物评价

Abstract: As an emerging treatment， cell therapy shows great potential in a variety of diseases， especially refractory ones. Cell therapy drugs include stem cells， immune cells and other terminally differentiated cells， which are reinfused into the body to achieve therapeutic effect after in vitro operation or genetic modification. However， given their unique biological characteristics， the pharmacokinetics (PK) study of cell therapy drugs presents many challenges. In this paper， we systematically review the PK characteristics of different kinds of cell therapy drugs， analyze the existing regulations and discuss the design of non-clinical PK studies and applicable bioanalytical methods of marketed drugs， to provide references for the development and evaluation of cell therapy drugs and promote the development and application in this field.

Key words: font-size:medium, ">Cell therapy； Pharmacokinetics； Non-clinical study； Drug evaluation

中图分类号:

汪宁1, 杨欢1, 徐楠楠1, 夏艳2, 侯德宝2, 刘颖3, 李洪贞1. 细胞治疗药物非临床药代动力学研究[J]. 中国药物评价, 2024, 41(6): 439-445.

WANG Ning1, YANG Huan1, XU Nan-nan1, XIA Yan2, HOU De-bao2, LIU Ying3, LI Hong-zhen1. Non-clinical Pharmacokinetic Studies of Cell Therapy Products[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2024, 41(6): 439-445.

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