Reflections on Model-Informed Drug Development

被引:0
|
作者
Lesko, Lawrence J. [1 ]
van der Graaf, Piet H. [2 ,3 ]
机构
[1] Univ Florida, Coll Pharm, Ctr Pharmacometr & Syst Pharmacol, Lake Nona, FL 32611 USA
[2] Certara, Appl BioSimulat, Canterbury, England
[3] Leiden Acad Ctr Drug Res, Leiden, Netherlands
关键词
D O I
10.1002/cpt.3335
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
引用
收藏
页码:267 / 270
页数:4
相关论文
共 50 条
  • [21] Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies
    Stephens, H.
    Koirala, B.
    Watson, K.
    Trame, M.
    Manon, A.
    Apgar, J.
    EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING, 2024, 51 : S833 - S833
  • [22] Accelerating Clinical Development of Janagliflozin, a Novel Antidiabetic Drug, Using Model-Informed Drug Development Strategy
    Liu, Dongyang
    Song, Ling
    Wang, Xiaoxu
    Liu, Xu
    Cao, Fangrui
    Liu, Hongzhong
    Ding, Yanhua
    Xiao, Xinhua
    Jiang, Ji
    Hu, Pei
    DIABETES, 2019, 68
  • [23] Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic
    Xiong, Ye
    Fan, Jianghong
    Kitabi, Eliford
    Zhang, Xinyuan
    Bi, Youwei
    Grimstein, Manuela
    Yang, Yuching
    Earp, Justin C.
    Zheng, Nan
    Liu, Jiang
    Wang, Yaning
    Zhu, Hao
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2022, 111 (03) : 572 - 578
  • [24] Opportunities and challenges for applying model-informed drug development approaches to gene therapies
    Belov, Artur
    Schultz, Kimberly
    Forshee, Richard
    Tegenge, Million A.
    CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2021, 10 (04): : 286 - 290
  • [25] Role of Model-Informed Drug Development in Confirming Additional Clinical Benefits of Dulaglutide
    Tham, Lai-San
    Geiser, Jeanne
    Tang, Cheng Cai
    Schneck, Karen
    Cox, David
    Milicevic, Zvonko
    Bethel, Angelyn
    DIABETES, 2020, 69
  • [26] Model-Informed Drug Development for Anti-Infectives: State of the Art and Future
    Rayner, Craig R.
    Smith, Patrick F.
    Andes, David
    Andrews, Kayla
    Derendorf, Hartmut
    Friberg, Lena E.
    Hanna, Debra
    Lepak, Alex
    Mills, Edward
    Polasek, Thomas M.
    Roberts, Jason A.
    Schuck, Virna
    Shelton, Mark J.
    Wesche, David
    Rowland-Yeo, Karen
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2021, 109 (04) : 867 - 891
  • [27] Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective
    Pan, Xiaolei
    Wang, Li
    Liu, Jiang
    Earp, Justin C.
    Yang, Yuching
    Yu, Jingyu
    Li, Fang
    Bi, Youwei
    Bhattaram, Atul
    Zhu, Hao
    JOURNAL OF CLINICAL PHARMACOLOGY, 2023, 63 : S65 - S77
  • [28] Model-Informed Drug Development Applications and Opportunities in mRNA-LNP Therapeutics
    Zhou, Jiawei
    Rao, Rohit
    Shapiro, Monica E.
    Tania, Nessy
    Herron, Cody
    Musante, Cynthia J.
    Hughes, Jim H.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2025,
  • [29] Editorial: Model-informed drug development and evidence-based translational pharmacology
    Zhao, Jinxin
    Zhu, Xiao
    Tan, Songwen
    Chen, Chuanpin
    Kaddoumi, Amal
    Guo, Xiu-Li
    Lin, Yu-Wei
    Cheung, S. Y. Amy
    FRONTIERS IN PHARMACOLOGY, 2022, 13
  • [30] Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation
    Marshall, S. F.
    Burghaus, R.
    Cosson, V.
    Cheung, S. Y. A.
    Chenel, M.
    DellaPasqua, O.
    Frey, N.
    Hamren, B.
    Harnisch, L.
    Ivanow, F.
    Kerbusch, T.
    Lippert, J.
    Milligan, P. A.
    Rohou, S.
    Staab, A.
    Steimer, J. L.
    Tornoe, C.
    Visser, S. A. G.
    CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2016, 5 (03): : 93 - 122