产品简述

体外PK/PD模型是指借助体外装罝来模拟药物在体内的药代动力学过程和药效动力学的研究方法。与传统的抗菌药物药效学研究方法相比，该模型能够直接体现体内抗菌药物动态变化过程中与细菌或细胞的相互作用，且不受实验动物的限制。

FiberCell系统可以实现单一药物或同时两种药物的体外PK/PD模型， 更精确的监控剂量和代谢状况。

欧盟药品监督管理局（EMA）已批准FiberCell系统用于体外毒性测试，得到的实验数据可用于临床申报。

参考文献

Comparison of in vitro static and dynamic assays to evaluate the efficacy of an antimicrobial drug combination against Staphylococcus aureus: Broussou, D. et al; PLOS ONE Jan 2019 [open access]

Clinical Regimens of Favipiravir Inhibit Zika Virus Replication in the Hollow-Fiber Infection Model:Camilly P. Pires de Mello et al.; Antimicrob Agents Chemother 2018 62 [abstract]

Differential Activity of the Combination of Vancomycin and Amikacin on Planktonic vs. Biofilm-Growing Staphylococcus aureus Bacteria in a Hollow Fiber Infection Model: Broussou, D. et al; Front. Microbiol., 27 March 2018 [open access]

Optimization and evaluation of piperacillin plus tobramycin combination dosage regimens against Pseudomonas aeruginosa for patients with altered pharmacokinetics via the hollow-fiber infection model and mechanism-based modelling: Yadav, R. et al; AMS 2018 (62) 3 [abstract]

Evaluation of Activity and Emergence of Resistance of Polymyxin B and ZTI-01 (Fosfomycin for Injection) against KPC-Producing Klebsiella pneumoniae: Diep, J.K. et al; Antimicrob. Agents Chemother. 2018 (62) 2 [open access]

Oseltamivir-zanamivir combination therapy suppresses drug-resistant H1N1 influenza A viruses in the hollow fiber infection model (HFIM) system: Pires de Mello, C.P.; European Journal of Pharmaceutical Sciences 111 (2018) 443-449 [open access]

Polymyxin Combinations Combat Escherichia coli Harboring mcr-1 and blaNDM-5: Preparation for a Postantibiotic Era. Bulman Z.PP; mBio 8(4)2017 [open access]

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Continuous culture of Cryptosporidium parvum using hollow fiber technology: Morada, M. et al.; Int J Parasitol. 2016 Jan;46(1):21-9 [related presentation PDF]

A long-term Co-perfused Disseminated Tuberculosis-3D Liver Hollow Fiber Model for Both Drug Efficacy and Hepatotoxicity in Babies: Srivastava, S. et al.; EBioMedicine 2016; 6:126-138 [open access]

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Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool: Romero, K., Clay, R. and Hanna, D.; Clinical Infectious Diseases 2015 61 (1): S5–9 [open access]

In Vitro Pharmacodynamics of Various Antibiotics in Combination against Extensively Drug-Resistant Klebsiella pneumoniae Lim, Tze-Peng et al.; Antimicrobial Agents and Chemother. 2015 59(5): 2515–2524.[open access]

Correlations Between the Hollow Fiber Model of Tuberculosis and Therapeutic Events in Tuberculosis Patients: Learn and Confirm: Gumbo, T.;2015 [open access]

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The in vitro hollow fiber system model has been qualified by the European Medicines Agency as a methodology for use in support of selection and development of antituberculosis regimens. More data are expected to be generated in the future to further characterize its value.

Rapid Drug Tolerance and Dramatic Sterilizing Effect of Moxifloxacin Monotherapy in a Novel Hollow-Fiber Model of Intracellular Mycobacterium kansasii Disease: Srivastava, S. et al.; Antimicrob. Agents Chemother. 2015, 59(4) [open access]

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Hollow-fiber pharmacodynamics studies and mathematical modeling to predict the efficacy of amoxicillin for anthrax postexposure prophylaxis in pregnant women and children. Louie, A et al.; Antimicrob Agents Chemother 2013; 57:5946–60. [open access]

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Effect of Half-Life on the Pharmacodynamic Index of Zanamivir against Influenza Virus Delineated by a Mathematical Model: Brown, A. et al.; Antimicrob. Agents Chemother. 2011 55 (4) 1747-1753[open access]

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Pharmacokinetic Mismatch Does Not Lead to Emergence of Isoniazid- or Rifampin-Resistant Mycobacterium tuberculosis but to Better Antimicrobial Effect: a New Paradigm for Antituberculosis Drug Scheduling: Srivastava, S. et al; Antimicrob. Agents Chemother. 2011 55 (11): 5085-5089 [open access]

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Optimizing the Culture of Plasmodium Falciparum in Hollow Fiber Bioreactors :Preechapornkul,P. et al.;Southeast Asian J Trop Med Public Health. 2010 41(4): 761–769 [open access]

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Pharmacodynamics of Cidofovir for Vaccinia Virus Infection in an In Vitro Hollow-Fiber Infection Model System. McSharry, J.; Antimicrob. Agents Chemother. 2009 53(1) 129-135 [open access] – system diagram

Pharmacodynamic Characterization of gemcitabine cytotoxicity in an in vitro cell culture bioreactor system. Kirstein MN, Brundage RC, Moore MM, Williams BW, Hillman LA, et al. 2008 Cancer Chemother Pharmacol 61: 291-299.

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