Extended Model-Informed Drug Development: Beyond Clinical Trials and Regulatory Approval

被引:4
|
作者
Kamal, Mohamed A. [1 ]
Ganguly, Samit [1 ]
Kadambi, Ananth [2 ]
Smith, Patrick F. [2 ]
机构
[1] Regeneron Pharmaceut, Tarrytown, NY 10591 USA
[2] Certara, Princeton, NJ 08540 USA
关键词
D O I
10.1002/cpt.3357
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
[No abstract available]
引用
收藏
页码:518 / 521
页数:4
相关论文
共 50 条
  • [41] Current status and challenges of model-informed drug discovery and development in China
    Wang, Yuzhu
    Ji, Jia
    Yao, Ye
    Nie, Jing
    Xie, Fengbo
    Xie, Yehua
    Li, Gailing
    ADVANCED DRUG DELIVERY REVIEWS, 2024, 214
  • [42] Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma
    Masters, Joanna C.
    Khandelwal, Akash
    di Pietro, Alessandra
    Dai, Haiqing
    Brar, Satjit
    CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2022, 11 (04): : 458 - 468
  • [43] Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective
    Ruo-Jing Li
    Lian Ma
    Hyewon Kim
    Insook Kim
    Lesley Hanes
    Tara Altepeter
    Jessica Lee
    Jiang Liu
    Hao Zhu
    Yaning Wang
    The AAPS Journal, 24
  • [44] Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective
    Li, Ruo-Jing
    Ma, Lian
    Kim, Hyewon
    Kim, Insook
    Hanes, Lesley
    Altepeter, Tara
    Lee, Jessica
    Liu, Jiang
    Zhu, Hao
    Wang, Yaning
    AAPS JOURNAL, 2022, 24 (04):
  • [45] Model-Informed Drug Discovery and Development Strategy for the Rapid Development of Anti-Tuberculosis Drug Combinations
    van Wijk, Rob C.
    Alsoud, Rami Ayoun
    Lennernas, Hans
    Simonsson, Ulrika S. H.
    APPLIED SCIENCES-BASEL, 2020, 10 (07):
  • [46] 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
  • [47] 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
  • [48] A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists
    Barrett, Jeffrey S.
    Romero, Klaus
    Rayner, Craig
    Gastonguay, Marc
    Pillai, Goonaseelan
    Tannenbaum, Stacey
    Kern, Steven
    Selich, Mark
    Francisco, Dave
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024, 116 (02) : 289 - 294
  • [49] 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
  • [50] 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