P Zhao

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc Towards quantitation of the effects of renal impairment and probenecid inhibition on kidney uptake and efflux transporters, using physiologically based pharmacokinetic modelling and simulations
    Vicky Hsu
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
    Clin Pharmacokinet 53:283-93. 2014
  2. doi request reprint Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation
    Ping Zhao
    Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:91S-108S. 2012
  3. doi request reprint Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions
    P Zhao
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 92:17-20. 2012
  4. ncbi request reprint Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy
    V Sinha
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 95:478-80. 2014
  5. doi request reprint Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor
    Md L T Vieira
    Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:700-8. 2012
  6. doi request reprint Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials
    R Leong
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:926-31. 2012
  7. ncbi request reprint PBPK model describes the effects of comedication and genetic polymorphism on systemic exposure of drugs that undergo multiple clearance pathways
    M D L T Vieira
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 95:550-7. 2014
  8. doi request reprint Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
    P Zhao
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 89:259-67. 2011
  9. doi request reprint Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug
    Md L T Vieira
    US Food and Drug Administration, Silver Spring, MD, USA
    Clin Pharmacol Ther 95:189-98. 2014

Collaborators

  • L Zhang
  • L J Lesko
  • H J Einolf
  • B Kirby
  • R S Obach
  • S D Hall
  • V Fischer
  • K Sandy Pang
  • Yuichi Sugiyama
  • S M Huang
  • Md L T Vieira
  • V Sinha
  • I Zineh
  • M D L T Vieira
  • Vicky Hsu
  • K S Reynolds
  • E G Berglund
  • R Leong
  • O A Fahmi
  • K Venkatakrishnan
  • J Snoeys
  • K Grime
  • T Waterhouse
  • J Y L Chien
  • S Apparaju
  • R Higgs
  • Eva Gil Berglund
  • D Plowchalk
  • A Galetin
  • Shiew Mei Huang
  • I Ragueneau-Majlessi
  • Kathleen M Giacomini
  • R Riley
  • Manuela de L T Vieira
  • A Fretland
  • Anna Nordmark
  • M J Kim
  • K Skordos
  • Jenny Huimin Zheng
  • E Seibert
  • M L T Vieira
  • C S Lee
  • G J Burckart
  • Y Mulugeta

Detail Information

Publications9

  1. pmc Towards quantitation of the effects of renal impairment and probenecid inhibition on kidney uptake and efflux transporters, using physiologically based pharmacokinetic modelling and simulations
    Vicky Hsu
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
    Clin Pharmacokinet 53:283-93. 2014
    ..The objective of this study was to use physiologically based pharmacokinetic (PBPK) modelling to evaluate the effects of patient factors on kidney transporters...
  2. doi request reprint Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation
    Ping Zhao
    Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:91S-108S. 2012
    ..The simulations demonstrate the utility and challenges of the PBPK approach in evaluating the pharmacokinetics of nonrenally cleared drugs in subjects with RI...
  3. doi request reprint Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions
    P Zhao
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 92:17-20. 2012
    ..This report summarizes the essential content of a PBPK analysis needed in a regulatory submission for the purpose of addressing clinical pharmacology questions...
  4. ncbi request reprint Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy
    V Sinha
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 95:478-80. 2014
    ....
  5. doi request reprint Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor
    Md L T Vieira
    Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:700-8. 2012
    ..In the absence of in vitro TDI data, a PBPK model can be used to incorporate TDI mechanisms based on nonlinear PK data to predict clinical drug-drug interactions...
  6. doi request reprint Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials
    R Leong
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:926-31. 2012
    ..PBPK modeling may have potential for improving pediatric trials through the learn-and-confirm approaches utilized in current regulatory submissions...
  7. ncbi request reprint PBPK model describes the effects of comedication and genetic polymorphism on systemic exposure of drugs that undergo multiple clearance pathways
    M D L T Vieira
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 95:550-7. 2014
    ....
  8. doi request reprint Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
    P Zhao
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 89:259-67. 2011
    ..The report also discusses the challenges encountered when PBPK modeling and simulation were used in these cases and recommends approaches to facilitating full utilization of this tool...
  9. doi request reprint Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug
    Md L T Vieira
    US Food and Drug Administration, Silver Spring, MD, USA
    Clin Pharmacol Ther 95:189-98. 2014
    ..Various cutoffs for predicting the likelihood of CYP3A inhibition were evaluated for mechanistic models, and a cutoff of 1.25-fold change in midazolam AUC appears appropriate. ..