James L Weaver

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Nonclinical evaluation of the potential for mast cell activation by an erythropoietin analog
    James L Weaver
    Division of Applied Regulatory Science, OCP OTS CDER FDA, Silver Spring, MD, USA Electronic address
    Toxicol Appl Pharmacol 287:246-52. 2015
  2. doi request reprint Establishing the carcinogenic risk of immunomodulatory drugs
    James L Weaver
    Division of Drug Safety Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 40:267-71. 2012
  3. doi request reprint Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385
    James L Weaver
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:840-9. 2008
  4. doi request reprint Early events in vascular injury in the rat induced by the phosphodiesterase IV inhibitor SCH 351591
    James L Weaver
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Toxicol Pathol 38:738-44. 2010
  5. doi request reprint Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385
    Jun Zhang
    Division of Applied Pharmacology Research HFD 910, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:827-39. 2008
  6. doi request reprint Effects of modulating in vivo nitric oxide production on the incidence and severity of PDE4 inhibitor-induced vascular injury in Sprague-Dawley rats
    CHRISTOPHER M SHETH
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Sci 122:7-15. 2011
  7. doi request reprint The Role of eNOS Phosphorylation in Causing Drug-induced Vascular Injury
    Grainne A McMahon Tobin
    Division of Applied Regulatory Science, CDER, U S Food and Drug Administration, Silver Spring, Maryland, USA
    Toxicol Pathol 42:709-24. 2014
  8. doi request reprint Development and validation of a liquid-chromatography tandem mass spectrometry method to determine in vitro and in vivo histamine release
    Krishna C Chimalakonda
    Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Division of Applied Regulatory Science, United States Food and Drug Administration, Silver Spring, MD, USA
    J Pharm Biomed Anal 102:494-9. 2015
  9. doi request reprint Isoproterenol-induced cardiotoxicity in sprague-dawley rats: correlation of reversible and irreversible myocardial injury with release of cardiac troponin T and roles of iNOS in myocardial injury
    Jun Zhang
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:277-8. 2008

Collaborators

Detail Information

Publications9

  1. doi request reprint Nonclinical evaluation of the potential for mast cell activation by an erythropoietin analog
    James L Weaver
    Division of Applied Regulatory Science, OCP OTS CDER FDA, Silver Spring, MD, USA Electronic address
    Toxicol Appl Pharmacol 287:246-52. 2015
    ..Significant release of histamine was detected in blood samples taken 2min after dosing at the highest concentrations tested. ..
  2. doi request reprint Establishing the carcinogenic risk of immunomodulatory drugs
    James L Weaver
    Division of Drug Safety Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 40:267-71. 2012
    ..Initial work is on various model systems similar to EBV. These include the MHV-68 mouse model, lymphocryptovirus (LCV-1) in the cynomolgus monkey, and preliminary work with mice with humanized immune systems using EBV directly...
  3. doi request reprint Biomarkers in peripheral blood associated with vascular injury in Sprague-Dawley rats treated with the phosphodiesterase IV inhibitors SCH 351591 or SCH 534385
    James L Weaver
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:840-9. 2008
    ..The changes in these parameters showed both a dose- and time-dependent association with histopathologic changes. These biomarkers could provide an additional tool for the nonclinical and clinical evaluation of investigational compounds...
  4. doi request reprint Early events in vascular injury in the rat induced by the phosphodiesterase IV inhibitor SCH 351591
    James L Weaver
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Toxicol Pathol 38:738-44. 2010
    ..At fifteen minutes, histopathology showed activation of mast cells, but not degranulation. Increases in endothelial activation and perivascular inflammatory cells were first apparent at thirty minutes and increased through 240 minutes...
  5. doi request reprint Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385
    Jun Zhang
    Division of Applied Pharmacology Research HFD 910, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:827-39. 2008
    ..The present study also provides a morphological and cellular basis for evaluating candidate biomarkers of drug-induced vascular injury...
  6. doi request reprint Effects of modulating in vivo nitric oxide production on the incidence and severity of PDE4 inhibitor-induced vascular injury in Sprague-Dawley rats
    CHRISTOPHER M SHETH
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Sci 122:7-15. 2011
    ..Conversely, coadministration of L-NAME resulted in marked reduction of injury, NT, and SN when compared with CI-1044 alone. The present study suggests that NO production is closely linked to PDE4i-induced vascular injury...
  7. doi request reprint The Role of eNOS Phosphorylation in Causing Drug-induced Vascular Injury
    Grainne A McMahon Tobin
    Division of Applied Regulatory Science, CDER, U S Food and Drug Administration, Silver Spring, Maryland, USA
    Toxicol Pathol 42:709-24. 2014
    ..The results suggested that phosphorylation of S615 may be associated with DIVI activity. Studies with the species-specific A2A adenosine agonist CI-947 in rats versus primates showed a similar pattern. ..
  8. doi request reprint Development and validation of a liquid-chromatography tandem mass spectrometry method to determine in vitro and in vivo histamine release
    Krishna C Chimalakonda
    Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Division of Applied Regulatory Science, United States Food and Drug Administration, Silver Spring, MD, USA
    J Pharm Biomed Anal 102:494-9. 2015
    ..Importantly, the LC-MS/MS assay may be useful in assessing active pharmaceutical ingredient-mediated degranulation and anaphylaxis as part of either a pre-market or a post-market assessment of drug products...
  9. doi request reprint Isoproterenol-induced cardiotoxicity in sprague-dawley rats: correlation of reversible and irreversible myocardial injury with release of cardiac troponin T and roles of iNOS in myocardial injury
    Jun Zhang
    Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 36:277-8. 2008
    ..These findings suggest that low doses of Iso exert complex effects on the myocardium and that the generation of NO through increased expression of iNOS could be an important factor in the pathogenesis of myocyte injury...