P Zhao

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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

Collaborators

Detail Information

Publications5

  1. 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...
  2. 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...
  3. 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...
  4. 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...
  5. 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...