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典型文献
《基于药代动力学方法支持PD-1/PD-L1单抗治疗肿瘤患者的替代剂量方案选择指南》解读
文献摘要:
近年来,以定量药理学为基础的模型化与仿真技术在新药研发中的地位日益凸显.2021年8月,FDA发布了《基于药代动力学方法支持PD-1/PD-L1单抗治疗肿瘤患者的替代剂量方案选择指南》征求意见稿(以下简称"《指南》"),提出基于群体PK(Pop-PK)模型仿真寻找替代方案的必要性和具体实施标准.本文首先对PD-1/PD-L1单抗的现有临床方案以及该指南的内容进行了总结,随后列举了基于Pop-PK仿真方法辅助替代方案获批的既往实际案例,并进一步分析了该指南用于PD-1/PD-L1单抗替代方案优化的要点,展望其对PD-1/PD-L1单抗临床研发的意义和价值,以期为国内同行提供参考.
文献关键词:
定量药理学;群体PK;模型仿真;模型引导的药物研发
作者姓名:
刘维;薛钧升;于之恒;王紫愉;陈镕;周田彦
作者机构:
北京大学第三医院药剂科,北京100191;北京大学药学院药剂学系,北京100191;北京大学第三医院妇产科,北京100191
引用格式:
[1]刘维;薛钧升;于之恒;王紫愉;陈镕;周田彦-.《基于药代动力学方法支持PD-1/PD-L1单抗治疗肿瘤患者的替代剂量方案选择指南》解读)[J].中国临床药理学与治疗学,2022(01):86-94
A类:
B类:
药代动力学,L1,单抗,肿瘤患者,剂量方案,方案选择,以定,定量药理学,模型化,仿真技术,新药研发,FDA,征求意见稿,PK,Pop,模型仿真,替代方案,临床方案,仿真方法,实际案例,方案优化,临床研发,模型引导的药物研发
AB值:
0.327478
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C.Hiemke;N.Bergemann;H.W.Clement;A.Conca;J.Deckert;K.Domschke;G.Eckermann;K.Egberts;M.Gerlach;C.Greiner;G.Gründer;E.Haen;U.Havemann-Reinecke;G.Hefner;R.Helmer;G.Janssen;E-.Jaquenoud;G.Laux;T.Messer;R.M?ssner;M.J.Müller;M.Paulzen;B.Pfuhlmann;P.Riederer;A.Saria;B.Schoppek;G.Schoretsanitis;M.Schwarz;M.Silva Gracia;B.Stegmann;W.Steimer;J.C.Stingl;M.Uhr;S.Ulrich;S.Unterecker;R.Waschgler;G.Zernig;G.Zurek;P.Baumann;李文标;果伟;贺静;鲍爽;路钊;牛梦溪;阮灿军;臧彦楠;王勇;张玲;刘辰庚;李洁-Department of Psychiatry and Psychotherapy,University Medical Center of Mainz,Mainz,Germany;Institute of Clinical Chemistry and Laboratory Medicine,University Medical Center of Mainz,Mainz,Germany;Kitzberg Hospitals,Center for Psychosomatic Medicine and Psychotherapy,Bad Mergentheim,Germany;Department of Child and Adolescent Psychiatry,University of Freiburg,Freiburg,Germany;Servizio Psichiatrico del Comprensorio Sanitario di Bolzano,Bolzano,Italy;Department of Psychiatry,Psychotherapy and Psychosomatics,University Hospital of Würzburg,Germany;Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg,Freiburg,Germany;Psychiatric Hospital,Kaufbeuren,Germany;Department of Child and Adolescent Psychiatry,Psychosomatics and Psychotherapy,Center of Mental Health,University Hospi-tal of Würzburg,Germany;Federal Institute for Drugs and Medical Devices (BfArM),Bonn,Germany;Department of Psychiatry,Psychotherapy and Psychosomatics,RWTH Aachen University,Aachen,and JARA–Translational Brain Medicine,Aachen,Germany;Clinical Pharmacology,Department of Psychiatry and Psychotherapy and Department of Pharmacology and Toxicology,Uni-versity of Regensburg,Regensburg,Germany;Department of Psychiatry and Psychosomatics,University of G?ttingen,G?ttingen,Germany;Psychiatric Hospital,Vitos Klinik,Eichberg,Eltville,Germany;Center of Epilepsy,Bielefeld,Germany;Medical Laboratory Stein,Limbach Group,M?nchengladbach,Germany;Psychiatric Hospital,K?nigsfelden,Brugg,Aargau,Switzerland;Institute of Psychological Medicine,Haag in Oberbayern,Germany;Danuviuskliniken,Psychiatric Hospital,Pfaffenhofen,Germany;Department of Psychiatry and Psychotherapy,University of Tübingen,Tübingen,Germany;Psychiatric Hospitals Oberberggruppe,Berlin,Germany;Psychiatric Hospital Weisser Hirsch,Dresden,Germany;Experimental Psychiatry Unit,Department of Psychiatry1,Medical University of Innsbruck,Innsbruck,Austria;kbo-Isar-Amper Klinikum München-Ost,Psychiatric Hospital,Munich-Haar,Germany;Department of Psychiatry,University of Bern,Bern,Switzerland;Department of Laboratory Medicine,Ludwig Maximilian University,Munich,Germany;Institute of Clinical Chemistry and Pathobiochemistry,Technical University Munich,Munich,Germany;Max Planck Institute of Psychiatry,Munich,Germany;Aristo Pharma GmbH,Berlin,Germany;Psychiatric Hospital,Feldkirch,Austria;Private Practice for Psychotherapy and Court-Certified Witness,Hall in Tirol,Austria;Medical Laboratory Bremen,Bremen,Germany;Department of Psychiatry,University of Lausanne,Prilly-Lausanne,Switzerland;中国 北京 首都医科大学附属北京安定医院,国家精神心理疾病临床医学研究中心,精神疾病诊断与治疗北京重点实验室;中国 天津 天津市安定医院
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