Gomeni R - Search Results

1

Use of predictive models in CNS diseases.

Gomeni R. Gomeni R. Curr Opin Pharmacol. 2014 Feb;14:23-9. doi: 10.1016/j.coph.2013.10.004. Epub 2013 Nov 16. Curr Opin Pharmacol. 2014. PMID: 24565008 Review.

2

Bayesian modelling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trials.

Gomeni R, Merlo-Pich E. Gomeni R, et al. Br J Clin Pharmacol. 2007 May;63(5):595-613. doi: 10.1111/j.1365-2125.2006.02815.x. Br J Clin Pharmacol. 2007. PMID: 17488364 Free PMC article.

3

Population Pharmacokinetic Modeling After Repeated Administrations of RBP-6000, a New, Subcutaneously Injectable, Long-Acting, Sustained-Release Formulation of Buprenorphine, for the Treatment of Opioid Use Disorder.

Laffont CM, Gomeni R, Heidbreder C, Jones JP 3rd, Nasser AF. Laffont CM, et al. Among authors: gomeni r. J Clin Pharmacol. 2016 Jul;56(7):806-15. doi: 10.1002/jcph.665. Epub 2016 Mar 11. J Clin Pharmacol. 2016. PMID: 26479717 Clinical Trial.

4

Is It Time for Going Beyond the P-Value Paradigm With the Estimation of the Probability of Clinical Benefit as a Criterion for Assessing the Outcomes of a Clinical Trial? A Case Study in Patients With Major Depressive Disorder.

Gomeni R, Bressolle-Gomeni F, Fava M. Gomeni R, et al. J Clin Pharmacol. 2018 Jun;58(6):740-749. doi: 10.1002/jcph.1074. Epub 2018 Jan 25. J Clin Pharmacol. 2018. PMID: 29372561

5

Model-Informed Approach to Assess the Treatment Effect Conditional to the Level of Placebo Response.

Gomeni R, Rabinowitz J, Goyal N, Bressolle-Gomeni FMM, Fava M. Gomeni R, et al. Clin Pharmacol Ther. 2019 Dec;106(6):1253-1260. doi: 10.1002/cpt.1584. Epub 2019 Aug 30. Clin Pharmacol Ther. 2019. PMID: 31397904

6

Modeling Complex Pharmacokinetics of Long-Acting Injectable Products Using Convolution-Based Models With Nonparametric Input Functions.

Gomeni R, Bressolle-Gomeni F. Gomeni R, et al. J Clin Pharmacol. 2021 Aug;61(8):1081-1095. doi: 10.1002/jcph.1842. Epub 2021 Mar 15. J Clin Pharmacol. 2021. PMID: 33606280 Free PMC article.

7

The role of placebo response in the efficacy outcome assessment in viloxazine extended-release pivotal trials in paediatric subjects with attention-deficit/hyperactivity disorder.

Nasser A, Gomeni R, Wang Z, Hull JT, Busse GD, Melyan Z, Fava M, O'Neal W, Rubin J. Nasser A, et al. Among authors: gomeni r. Br J Clin Pharmacol. 2022 Nov;88(11):4828-4838. doi: 10.1111/bcp.15412. Epub 2022 Jun 8. Br J Clin Pharmacol. 2022. PMID: 35588245 Free PMC article.

8

Modelling placebo response in depression trials using a longitudinal model with informative dropout.

Gomeni R, Lavergne A, Merlo-Pich E. Gomeni R, et al. Eur J Pharm Sci. 2009 Jan 31;36(1):4-10. doi: 10.1016/j.ejps.2008.10.025. Epub 2008 Nov 8. Eur J Pharm Sci. 2009. PMID: 19041717 Review.

9

Trial Simulation to estimate Type I error when a population window enrichment strategy is used to improve efficiency of clinical trials in depression.

Gomeni R, Merlo-Pich E. Gomeni R, et al. Eur Neuropsychopharmacol. 2012 Jan;22(1):44-52. doi: 10.1016/j.euroneuro.2011.05.002. Epub 2011 Jun 1. Eur Neuropsychopharmacol. 2012. PMID: 21636257

10

Amyotrophic lateral sclerosis disease progression model.

Gomeni R, Fava M; Pooled Resource Open-Access ALS Clinical Trials Consortium. Gomeni R, et al. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Mar;15(1-2):119-29. doi: 10.3109/21678421.2013.838970. Epub 2013 Sep 26. Amyotroph Lateral Scler Frontotemporal Degener. 2014. PMID: 24070404

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