Affiliation: GlaxoSmithKline Research and Development
- Bayesian modelling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trialsRoberto 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...
- Modeling Alzheimer's disease progression using the disease system analysis approachRoberto Gomeni
Pharmacometrics, GlaxoSmithKline R and D, Upper Merion, PA, USA
Alzheimers Dement 8:39-50. 2012....
- Modelling placebo response in depression trials using a longitudinal model with informative dropoutRoberto 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...
- Trial Simulation to estimate Type I error when a population window enrichment strategy is used to improve efficiency of clinical trials in depressionRoberto 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...
- In silico prediction of optimal in vivo delivery properties using convolution-based model and clinical trial simulationRoberto 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...
- A latent variable approach in simultaneous modeling of longitudinal and dropout data in schizophrenia trialsNavin 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. ..
- Exposure-response modeling of anti-depressant treatments: the confounding role of placebo effectNavin 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...
- Sensitivity of the individual items of the Hamilton depression rating scale to response and its consequences for the assessment of efficacyGijs 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...
- Multiple dose pharmacokinetics of paroxetine in children and adolescents with major depressive disorder or obsessive-compulsive disorderRobert 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...