Roberto Gomeni

Summary

Affiliation: GlaxoSmithKline Research and Development
Country: USA

Publications

  1. pmc Bayesian modelling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trials
    Roberto Gomeni
    CPK Modelling and Simulation, GlaxoSmithKline, Verona, Italy
    Br J Clin Pharmacol 63:595-613. 2007
  2. doi Modeling Alzheimer's disease progression using the disease system analysis approach
    Roberto Gomeni
    Pharmacometrics, GlaxoSmithKline R and D, Upper Merion, PA, USA
    Alzheimers Dement 8:39-50. 2012
  3. doi Modelling placebo response in depression trials using a longitudinal model with informative dropout
    Roberto Gomeni
    Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Verona, Italy
    Eur J Pharm Sci 36:4-10. 2009
  4. doi Trial Simulation to estimate Type I error when a population window enrichment strategy is used to improve efficiency of clinical trials in depression
    Roberto Gomeni
    Pharmacometrics, GlaxoSmithKline R and D, King of Prussia, PA, United States
    Eur Neuropsychopharmacol 22:44-52. 2012
  5. ncbi In silico prediction of optimal in vivo delivery properties using convolution-based model and clinical trial simulation
    Roberto Gomeni
    GlaxoSmithKline, Verona, Italy
    Pharm Res 19:99-103. 2002
  6. doi Exposure-response modeling of anti-depressant treatments: the confounding role of placebo effect
    Navin Goyal
    Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Upper Merion, PA, USA
    J Pharmacokinet Pharmacodyn 40:389-99. 2013
  7. doi A latent variable approach in simultaneous modeling of longitudinal and dropout data in schizophrenia trials
    Navin Goyal
    Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, King of Prussia, PA, USA
    Eur Neuropsychopharmacol 23:1570-6. 2013
  8. doi Sensitivity of the individual items of the Hamilton depression rating scale to response and its consequences for the assessment of efficacy
    Gijs Santen
    Division of Pharmacology, Leiden Amsterdam Center for Drug Research, P O Box 9502, Leiden, The Netherlands
    J Psychiatr Res 42:1000-9. 2008
  9. ncbi Multiple dose pharmacokinetics of paroxetine in children and adolescents with major depressive disorder or obsessive-compulsive disorder
    Robert L Findling
    Department of Psychiatry, Case Western Reserve University, University Hospitals of Cleveland, OH 44106 5080, USA
    Neuropsychopharmacology 31:1274-85. 2006

Collaborators

Detail Information

Publications9

  1. pmc Bayesian modelling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trials
    Roberto Gomeni
    CPK Modelling and Simulation, GlaxoSmithKline, Verona, Italy
    Br J Clin Pharmacol 63:595-613. 2007
    ..g. HAMD-17) are associated with response at end-point. * Unpredictable placebo response is one of the major reasons for clinical trial failure in the evaluation of antidepressant drugs...
  2. doi Modeling Alzheimer's disease progression using the disease system analysis approach
    Roberto Gomeni
    Pharmacometrics, GlaxoSmithKline R and D, Upper Merion, PA, USA
    Alzheimers Dement 8:39-50. 2012
    ....
  3. doi Modelling placebo response in depression trials using a longitudinal model with informative dropout
    Roberto Gomeni
    Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Verona, Italy
    Eur J Pharm Sci 36:4-10. 2009
    ..01) than "Missing Completely At Random" model. This finding provided new insights on the validity of the analyses currently used in many longitudinal clinical trials to support the registration of a new medicinal product...
  4. doi Trial Simulation to estimate Type I error when a population window enrichment strategy is used to improve efficiency of clinical trials in depression
    Roberto Gomeni
    Pharmacometrics, GlaxoSmithKline R and D, King of Prussia, PA, United States
    Eur Neuropsychopharmacol 22:44-52. 2012
    ..The results indicated that EWS preserved the Type I error showing no bias, at variance with other procedures. These results were confirmed by simulating 13 three-arm placebo controlled RCTs from the GSK Clinical Database...
  5. ncbi In silico prediction of optimal in vivo delivery properties using convolution-based model and clinical trial simulation
    Roberto Gomeni
    GlaxoSmithKline, Verona, Italy
    Pharm Res 19:99-103. 2002
    ..To develop a new strategy for the in silico evaluation of the optimal in vivo delivery properties of a drug, minimizing a cost function defined by the brain receptor occupancy obtained in positron-emission tomography experiments...
  6. doi Exposure-response modeling of anti-depressant treatments: the confounding role of placebo effect
    Navin Goyal
    Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Upper Merion, PA, USA
    J Pharmacokinet Pharmacodyn 40:389-99. 2013
    ..With this novel approach, a more accurate estimate of the dose/exposure response can be derived and more informed go/no-go decisions can be made in developing drugs for psychiatric disorders...
  7. doi A latent variable approach in simultaneous modeling of longitudinal and dropout data in schizophrenia trials
    Navin Goyal
    Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, King of Prussia, PA, USA
    Eur Neuropsychopharmacol 23:1570-6. 2013
    ..The analysis provides a framework to model informative dropouts simultaneously with primary efficacy outcomes and make intelligent decisions in drug development. ..
  8. doi Sensitivity of the individual items of the Hamilton depression rating scale to response and its consequences for the assessment of efficacy
    Gijs Santen
    Division of Pharmacology, Leiden Amsterdam Center for Drug Research, P O Box 9502, Leiden, The Netherlands
    J Psychiatr Res 42:1000-9. 2008
    ..This response-based subscale increases signal-to-noise ratio and could reduce failure rate in efficacy trials with antidepressant drugs...
  9. ncbi Multiple dose pharmacokinetics of paroxetine in children and adolescents with major depressive disorder or obsessive-compulsive disorder
    Robert L Findling
    Department of Psychiatry, Case Western Reserve University, University Hospitals of Cleveland, OH 44106 5080, USA
    Neuropsychopharmacology 31:1274-85. 2006
    ..Certain gastrointestinal and behavioral activation events (aggressive reaction and nervousness) were reported more frequently in the youngest age group...