Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design

被引:0
|
作者
Valvanera Vozmediano
Ander Sologuren
John C. Lukas
Nerea Leal
Mónica Rodriguez
机构
[1] Drug Modeling & Consulting,
[2] Dynakin,undefined
[3] SL,undefined
[4] Clinical Research Department,undefined
[5] FAES FARMA,undefined
[6] S.A.,undefined
来源
Pharmaceutical Research | 2017年 / 34卷
关键词
bilastine; knowledge integration; Ontogenic model; pediatric drug development; quantitative pharmacology; semiphysiological;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:2720 / 2734
页数:14
相关论文
共 50 条
  • [1] Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design
    Vozmediano, Valvanera
    Sologuren, Ander
    Lukas, John C.
    Leal, Nerea
    Rodriguez, Monica
    [J]. PHARMACEUTICAL RESEARCH, 2017, 34 (12) : 2720 - 2734
  • [2] Model-informed pediatric development applied to bilastine: Analysis of the clinical PK data and confirmation of the dose selected for the target population
    Vozmediano, Valvanera
    Lukas, John C.
    Encinas, Esther
    Schmidt, Stephan
    Sologuren, Ander
    Valiente, Roman
    Labeaga, Luis
    Campo, Cristina
    Rodriguez, Monica
    [J]. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2019, 128 : 180 - 192
  • [3] Model-Informed Drug Development in Pediatric Dose Selection
    Bi, Youwei
    Liu, Jiang
    Li, Fang
    Yu, Jingyu
    Bhattaram, Atul
    Bewernitz, Michael
    Li, Ruo-jing
    Ahn, Jihye
    Earp, Justin
    Ma, Lian
    Zhuang, Luning
    Yang, Yuching
    Zhang, Xinyuan
    Zhu, Hao
    Wang, Yaning
    [J]. JOURNAL OF CLINICAL PHARMACOLOGY, 2021, 61 : S60 - S69
  • [4] Model-Informed Drug Development for Antimicrobials: Translational PK and PK/PD Modeling to Predict an Efficacious Human Dose for Apramycin
    Sou, Tomas
    Hansen, Jon
    Liepinsh, Edgars
    Backlund, Maria
    Ercan, Onur
    Grinberga, Solveiga
    Cao, Sha
    Giachou, Paraskevi
    Petersson, Anna
    Tomczak, Magdalena
    Urbas, Malgorzata
    Zabicka, Dorota
    Vingsbo Lundberg, Carina
    Hughes, Diarmaid
    Hobbie, Sven N.
    Friberg, Lena E.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2021, 109 (04) : 1063 - 1073
  • [5] SYSTEMS PK/PD MODEL INFORMED DISCOVERY AND DEVELOPMENT OF CANCER IMMUNOTHERAPY
    Shah, Dhaval
    [J]. DRUG METABOLISM AND PHARMACOKINETICS, 2020, 35 (01) : S9 - S9
  • [6] Feasibility of retrospective quantification of diagnostic pediatric images for pharmacokinetic (PK) model development
    Plyku, Donika
    Frey, Eric
    Fahey, Frederic
    Cao, Xinhua
    Treves, S. Ted
    Bolch, Wesley
    Sgouros, George
    [J]. JOURNAL OF NUCLEAR MEDICINE, 2015, 56 (03)
  • [7] MODEL-INFORMED DOSE SELECTION FOR PEDIATRIC STUDY OF EMICIZUMAB IN HEMOPHILIA
    Yoneyama, A. K.
    Schmitt, C.
    Chang, T.
    Levy, G. G.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2018, 103 : S94 - S94
  • [8] Model-Informed Pediatric Drug Development: Application of Pharmacometrics to Define the Right Dose for Children
    Vinks, Alexander A.
    Barrett, Jeffrey S.
    [J]. JOURNAL OF CLINICAL PHARMACOLOGY, 2021, 61 : S52 - S59
  • [9] A Model-Based Approach to Dose Selection in Early Pediatric Development
    Cella, M.
    de Vries, F. Gorter
    Burger, D.
    Danhof, M.
    Della Pasqua, O.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2010, 87 (03) : 294 - 302
  • [10] Challenges in Developing a Population Pharmacokinetic Model Describing the PK of Atazanavir and Supporting Dose Selection in HIV infected Pediatric Subjects
    Sevinsky, Heather
    Cirincione, Brenda
    Raybon, Joseph
    Perera, Vidya
    Luo, Man Melody
    Eley, Timothy
    Mager, Donald E.
    VanWart, Scott
    LaCreta, Frank
    Girgis, Ihab
    [J]. JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2016, 43 : S20 - S20