PATH TO REGULATORY REVIEW OF A QUANTITATIVE SYSTEM PHARMACOLOGY (QSP) MODEL

被引:0
|
作者
Liu, G. [1 ]
Yang, Y. [1 ]
Zhu, H. [1 ]
机构
[1] US FDA, Silver Spring, MD USA
关键词
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
LB-023
引用
收藏
页码:S34 / S34
页数:1
相关论文
共 50 条
  • [41] Development of a Quantitative Systems Pharmacology (QSP) Platform to Support Translational Research and Clinical Development of Affinity Drug Conjugates (ADCs)
    Schmidt, Brian J.
    Vezina, Heather E.
    Gupta, Manish
    Leil, Tarek A.
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2015, 42 : S66 - S67
  • [42] DEVELOPMENT OF A QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL TO EVALUATE THE THERAPEUTIC POTENTIAL OF ANTI-CD19 CAR-T IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
    Park, H.
    Mugundu, G.
    Singh, A.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024, 115 : S18 - S19
  • [43] Development of a Quantitative Systems Pharmacology (QSP) Toolbox and Virtual Population (VPop) for Affinity-Drug Conjugate (ADC) Research
    Cheng, Yougan
    Vezina, Heather E.
    Gupta, Manish
    Pan, Chin
    Leil, Tarek A.
    Schmidt, Brian J.
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2016, 43 : S47 - S47
  • [44] Development of a quantitative systems pharmacology (QSP) model to support dose optimization of DS-1103a (anti SIRPa antibody) in combination with trastuzumab deruxtecan in patients with cancer
    Cheng, Yougan
    Vuppala, Pradeep
    Sarma, Uddipan
    Chelliah, Viji
    van der Graaf, Piet
    Karibe, Tsuyoshi
    Hayashi, Shinko
    Tsubaki, Takuya
    Kawasaki, Norihito
    Ishimoto, Yoko
    Herrmann, Monika
    Sue, Mayumi
    Mires, Derek E.
    Toso, John F.
    Lau, Yvonne Y.
    Leil, Tarek
    JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (16)
  • [45] DEVELOPMENT OF A QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL TO EVALUATE THE THERAPEUTIC POTENTIAL OF ANTI-CD19 CAR-T IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
    Park, H.
    Mugundu, G.
    Singh, A.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024, 115 : S44 - S44
  • [46] A Quantitative Systems Pharmacology (QSP) model to characterize dosedependent antitumor activity of AZD5305, PARP1 selective inhibitor, across multiple xenograft models
    Moorthy, Ganesh
    Voronova, Veronika
    Pichardo, Cesar
    Peskov, Kirill
    Illuzzi, Giuditta
    Staniszewska, Anna
    Albertella, Mark
    Kimko, Holly
    CANCER RESEARCH, 2023, 83 (07)
  • [47] Two heads are better than one: current landscape of integrating QSP and machine learning An ISoP QSP SIG white paper by the working group on the integration of quantitative systems pharmacology and machine learning
    Zhang, Tongli
    Androulakis, Ioannis P.
    Bonate, Peter
    Cheng, Limei
    Helikar, Tomas
    Parikh, Jaimit
    Rackauckas, Christopher
    Subramanian, Kalyanasundaram
    Cho, Carolyn R.
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2022, 49 (01) : 5 - 18
  • [48] Two heads are better than one: current landscape of integrating QSP and machine learningAn ISoP QSP SIG white paper by the working group on the integration of quantitative systems pharmacology and machine learning
    Tongli Zhang
    Ioannis P. Androulakis
    Peter Bonate
    Limei Cheng
    Tomáš Helikar
    Jaimit Parikh
    Christopher Rackauckas
    Kalyanasundaram Subramanian
    Carolyn R. Cho
    Journal of Pharmacokinetics and Pharmacodynamics, 2022, 49 : 5 - 18
  • [49] A QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL FOR PREDICTING EFFICACY FOR A COMBINATION OF AN ANTIBODY DRUG CONJUGATE (ADC) AND A CHECKPOINT INHIBITOR (CPI) IN PHASE II/III CLINICAL TRIALS.
    Prabhakar, V.
    Sing, R.
    Dutta, R.
    Mehra, D.
    Sareen, A.
    Paleja, B.
    Channavazzala, M.
    Chakravarthy, S. Pallikonda
    Thiagarajan, K.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024, 115 : S119 - S119
  • [50] GPS for QSP: A Summary of the ACoP6 Symposium on Quantitative Systems Pharmacology and a Stage for Near-Term Efforts in the Field
    Musante, C. J.
    Abernethy, D. R.
    Allerheiligen, S. R.
    Lauffenburger, D. A.
    Zager, M. G.
    CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2016, 5 (09): : 449 - 451