L Zhang

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:79S-90S. 2012
  2. doi request reprint Transporter-mediated drug-drug interactions
    L Zhang
    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 89:481-4. 2011
  3. ncbi request reprint Scientific and regulatory perspectives on metabolizing enzyme-transporter interplay and its role in drug interactions: challenges in predicting drug interactions
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Mol Pharm 6:1766-74. 2009
  4. ncbi request reprint When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective
    S M Huang
    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 86:475-9. 2009
  5. doi request reprint Therapeutic protein-drug interactions and implications for drug development
    S M Huang
    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 87:497-503. 2010
  6. ncbi request reprint A regulatory viewpoint on transporter-based drug interactions
    L Zhang
    Offices of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Xenobiotica 38:709-24. 2008
  7. 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
  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. pmc Assessing sources of inconsistencies in genotypes and their effects on genome-wide association studies with HapMap samples
    H Hong
    Division of Systems Toxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA
    Pharmacogenomics J 10:364-74. 2010
  10. ncbi request reprint The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies
    S U Yasuda
    Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:417-23. 2008

Collaborators

Detail Information

Publications17

  1. doi request reprint Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Clin Pharmacol 52:79S-90S. 2012
    ..The objective of this article is to discuss the FDA's current recommendations and provide examples that illustrate the importance of and challenges in studying effect of renal impairment during drug development...
  2. doi request reprint Transporter-mediated drug-drug interactions
    L Zhang
    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 89:481-4. 2011
    ..Like metabolizing enzymes, transporters have binding sites that are saturable and can be inhibited or induced...
  3. ncbi request reprint Scientific and regulatory perspectives on metabolizing enzyme-transporter interplay and its role in drug interactions: challenges in predicting drug interactions
    Lei Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Mol Pharm 6:1766-74. 2009
    ..Finally, the discussion will focus on the need to leverage current knowledge to obtain more meaningful drug interaction information...
  4. ncbi request reprint When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective
    S M Huang
    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 86:475-9. 2009
    ....
  5. doi request reprint Therapeutic protein-drug interactions and implications for drug development
    S M Huang
    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 87:497-503. 2010
    ..The draft guidance updated the FDA's recommendations on the evaluation of important cytochrome P450 (CYP) enzyme- and transporter-based drug interactions during drug development...
  6. ncbi request reprint A regulatory viewpoint on transporter-based drug interactions
    L Zhang
    Offices of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Xenobiotica 38:709-24. 2008
    ..In addition, it includes a review case that describes the evaluation of data suggesting a P-gp-based induction interaction...
  7. 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...
  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. pmc Assessing sources of inconsistencies in genotypes and their effects on genome-wide association studies with HapMap samples
    H Hong
    Division of Systems Toxicology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA
    Pharmacogenomics J 10:364-74. 2010
    ..Our studies show that inconsistencies between SNP arrays and between genotype calling algorithms are potential sources for the lack of reproducibility in GWAS results...
  10. ncbi request reprint The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies
    S U Yasuda
    Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:417-23. 2008
    ..fda.gov/cder/Offices/OCPB/workshops.htm)...
  11. doi request reprint The International Transporter Consortium: a collaborative group of scientists from academia, industry, and the FDA
    S M Huang
    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 87:32-6. 2010
    ..2) As a result of the Critical Path Initiative and enormous advances in the field of membrane transporters, the International Transporter Consortium was formed...
  12. doi request reprint Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications
    Y Zhang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 85:305-11. 2009
    ....
  13. doi request reprint Assessment of variability in GWAS with CRLMM genotyping algorithm on WTCCC coronary artery disease
    L Zhang
    Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20903, USA
    Pharmacogenomics J 10:347-54. 2010
    ..Our findings are critical to optimize the reproducibility of GWAS and confirm the genetic role in the pathophysiology of CAD...
  14. 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. ..
  15. ncbi request reprint pH-Dependent Drug-Drug Interactions for Weak Base Drugs: Potential Implications for New Drug Development
    L Zhang
    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 96:266-77. 2014
    ..Important study design considerations include selection of ARAs and timing of dosing of an ARA relative to the WBD in a DDI study. Labeling implications for drugs having DDIs with ARAs are also illustrated. ..
  16. doi request reprint Office of clinical pharmacology science day: a forum to stimulate innovation in clinical pharmacology
    R P Owen
    Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 93:471-3. 2013
    ..This article discusses the evolution of Science Day and then focuses on SD 2012 as an example platform for promotion of regulatory research...
  17. ncbi request reprint Serial analysis of gene expression in the frontal cortex of patients with bipolar disorder
    Y Sun
    Stanley Division of Developmental Neurovirology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    Br J Psychiatry Suppl 41:s137-41. 2001
    ..CONCLUSION: The SAGE technique offers promise for the characterisation of complex human brain diseases...