Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges

被引：19
|
作者：
Musuamba, Flora T. [1 ,2 ,3 ]
Bursi, Roberta [4 ]
Manolis, Efthymios [1 ,5 ]
Karlsson, Kristin [1 ,6 ]
Kulesza, Alexander [7 ]
Courcelles, Eulalie [7 ]
Boissel, Jean-Pierre [7 ]
Lesage, Raphaelle [8 ]
Crozatier, Cecile [9 ]
Voisin, Emmanuelle M. [9 ]
Rousseau, Cecile F. [9 ]
Marchal, Thierry [10 ]
Alessandrello, Rossana [11 ]
Geris, Liesbet [8 ,12 ]
机构：
[1] EMA Modelling & Simulat Working Party, Amsterdam, Netherlands
[2] Fed Agcy Med & Hlth Prod, Brussels, Belgium
[3] Univ Lubumbashi, Fac Sci Pharmaceut, Lubumbashi, DEM REP CONGO
[4] InSilicoTrials Technol, Milan, Italy
[5] European Med Agcy, Amsterdam, Netherlands
[6] Med Prod Agcy, Uppsala, Sweden
[7] Novadiscovery, Lyon, France
[8] Katholieke Univ Leuven, Leuven, Belgium
[9] Voisin Consulting Life Sci, Paris, France
[10] Ansys, Wavre, Belgium
[11] AQuAS Agcy Hlth Qual & Assessment Catalonia, Catalonia, Spain
[12] Univ Liege, Liege, Belgium
来源：
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY | 2020年 / 9卷 / 04期
关键词：
D O I：
10.1002/psp4.12504
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
引用
收藏
页码：195 / 197
页数：3
相关论文
共 50 条
  • [31] Model innovation in Parkinson's disease drug development: linking Quantitative Systems Pharmacology to the patient voice
    Barrett, J.
    Piccoli, B.
    Muller, M.
    Barrett, K.
    Goncharov, D.
    Kaddi, C.
    Azer, K.
    Romero, K.
    Stephenson, D.
    MOVEMENT DISORDERS, 2021, 36 : S126 - S126
  • [32] Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development: A Workshop Report
    Bai, Jane P. F.
    Stinchcomb, Audra L.
    Wang, Jie
    Earp, Justin
    Stern, Sydney
    Schuck, Robert N.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024, 115 (02) : 201 - 205
  • [33] A quantitative systems pharmacology model to describe the immunopathogenesis of inflammatory bowel disease and guide drug development decisions
    Ramakrishnan, Vidya
    Lu, Pinyi
    McBride, Jacqueline
    Fuh, Franklin
    Lekkerkerker, Annemarie
    Tang, Meina
    Leber, Andrew
    Hontecillas, Raquel
    Quartino, Angelica
    Jin, Jin Yan
    Bassaganya-Riera, Josep
    Ramanujan, Saroja
    Gadkar, Kapil
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2018, 45 : S85 - S85
  • [34] 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
  • [35] Evaluation of the utility of a MATLAB and R-based workflow for the development of quantitative systems pharmacology (QSP) models
    Sokolov, Victor
    Dolgun, Artem
    Zhudenkov, Kirill
    Schmidt, Henning
    Peskov, Kirill
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2018, 45 : S133 - S134
  • [36] INTEGRATION OF QUANTITATIVE SYSTEMS PHARMACOLOGY AND HEALTH ECONOMICS MODELS FOR DRUG DEVELOPMENT DECISION MAKING: APPLICATION TO TREATMENT OF SKELETAL RELATED EVENTS IN PATIENTS WITH BONE METASTASES
    Gastonguay, M.
    Riggs, M.
    Johnson, M.
    VALUE IN HEALTH, 2020, 23 : S31 - S31
  • [37] Assessing the Role of Quantitative Systems Pharmacology Modeling in the Early Stage Drug Development for Urea Cycle Disorders.
    Baillie, Rebecca
    Weis, Michael
    Reed, Mike
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2017, 44 : S72 - S73
  • [38] Coupling quantitative systems pharmacology modelling to machine learning and artificial intelligence for drug development: its pAIns and gAIns
    Folguera-Blasco, Nuria
    Boshier, Florencia A. T.
    Uatay, Aydar
    Pichardo-Almarza, Cesar
    Lai, Massimo
    Biasetti, Jacopo
    Dearden, Richard
    Gibbs, Megan
    Kimko, Holly
    FRONTIERS IN SYSTEMS BIOLOGY, 2024, 4
  • [39] Development of a quantitative systems pharmacology model of drug-induced renal proximal tubule injury for benchmarking and translation
    Gebremichael, Yeshitila
    Lu, James
    Shankaran, Harish
    Mettetal, Jerome
    Helmlinger, Gabriel
    Hallow, Melissa
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2016, 43 : S46 - S47
  • [40] Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform
    Franssen, Linnea C. C.
    Swat, Maciej J. J.
    Kierzek, Andrzej M. M.
    Rose, Rachel H. H.
    van Der Graaf, Piet H. H.
    Grimm, Hans Peter
    CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2023, 12 (02): : 139 - 143
12345