Emilio Merlo Pich
Affiliation: GlaxoSmithKline Research and Development
- A new population-enrichment strategy to improve efficiency of placebo-controlled clinical trials of antidepressant drugsE Merlo-Pich
Neurosciences Center of Excellence for Drug Discovery, GlaxoSmithKline R and D, Verona, Italy
Clin Pharmacol Ther 88:634-42. 2010..Clinical trial simulation was used to assess the enrichment strategy applied before the standard statistical analysis, resulting in an overall reduction in failure of RCTs from ~50 to ~10%...
- Understanding pharmacology in humans: Phase I and Phase II (data generation)Emilio Merlo Pich
Discovery Performance Unit on Neuronal Targets, Respiratory Disorder Therapeutic Area, GlaxoSmithKline Ltd, King of Prussia, PA 19123, USA
Curr Opin Pharmacol 11:557-62. 2011..This path, also supported by regulatory agencies, is calling for an important change of perspective about how drug discovery is made, which we believe should start from the full implementation of the paradigm of Translational Medicine...
- Upregulation of [3H]methyllycaconitine binding sites following continuous infusion of nicotine, without changes of alpha7 or alpha6 subunit mRNA: an autoradiography and in situ hybridization study in rat brainManolo Mugnaini
Biology Department, Psychiatry CEDD, GlaxoSmithKline S p A, Medicines Research Centre, Verona, Italy
Eur J Neurosci 16:1633-46. 2002..Finally, the present results provide the first anatomical description of the distribution of [3H]MLA binding sites in rat brain...
- 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...
- Pharmacokinetics and time-course of D(2) receptor occupancy induced by atypical antipsychotics in stabilized schizophrenic patientsA M Catafau
Experimental Medical Sciences, Clinical Pharmacology Discovery Medicine, Psychiatry Centre of Excellence for Drug Discovery, GlaxoSmithKline, Barcelona, Spain
J Psychopharmacol 22:882-94. 2008..D(2)RO patterns over time differ between AP. These results should be considered for accurate interpretation of D(2)RO measurements, proper design of studies and optimization of drug regimens for patients on AP treatment...
- Model-based approach and signal detection theory to evaluate the performance of recruitment centers in clinical trials with antidepressant drugsE Merlo-Pich
Experimental Medical Science, Clinical Pharmacology Discovery Medicine, GlaxoSmithKline, Verona, Italy
Clin Pharmacol Ther 84:378-84. 2008..A further analysis indicated that a minimal sample of four subjects is required in order to predict the typical placebo response in each center...