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Expert Opinion on Drug Discovery Volume 4, 2009 - Issue 8
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Reviews

Model-based approaches to increase efficiency of drug development in schizophrenia: a can't miss opportunity

Gianluca Nucci Clinical Pharmacology, Pfizer Global Research and Development, 50 Pequot Avenue, CT 06320, New London, USA
,
Roberto Gomeni Pharmacometrics and Clinical Pharmacology-Modeling & Simulation, GlaxoSmithKline, Via Fleming 4, 37135, Verona, Italy
&
Italo Poggesi Clinical Pharmacology-Modeling & Simulation, GlaxoSmithKline, Via Fleming 4, Verona, 37135, Italy +39 0458219803; +39 0458218191; [email protected]
Pages 837-856 | Published online: 24 Jun 2009

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Jean-Michel Azorin & Nicolas Simon. (2020) Antipsychotic polypharmacy in schizophrenia: evolving evidence and rationale. Expert Opinion on Drug Metabolism & Toxicology 16:12, pages 1175-1186.
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Roberto Gomeni & Maurizio Fava. (2014) Amyotrophic lateral sclerosis disease progression model. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 15:1-2, pages 119-129.
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Articles from other publishers (22)

Shamir N. Kalaria, Tiffany R. Farchione, Mitchell V. Mathis, Mathangi Gopalakrishnan, Islam Younis, Ramana Uppoor, Mehul Mehta, Yaning Wang & Hao Zhu. (2020) Assessment of Similarity in Antipsychotic Exposure‐Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia. The Journal of Clinical Pharmacology 60:7, pages 848-859.
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Shamir N. Kalaria, Hao Zhu, Tiffany R. Farchione, Mitchell V. Mathis, Mathangi Gopalakrishnan, Ramana Uppoor, Mehul Mehta & Islam Younis. (2019) A Quantitative Justification of Similarity in Placebo Response Between Adults and Adolescents With Acute Exacerbation of Schizophrenia in Clinical Trials. Clinical Pharmacology & Therapeutics 106:5, pages 1046-1055.
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Yin Cheong Wong, Maddalena Centanni & Elizabeth C. M. Lange. (2019) Physiologically Based Modeling Approach to Predict Dopamine D2 Receptor Occupancy of Antipsychotics in Brain: Translation From Rat to Human. The Journal of Clinical Pharmacology 59:5, pages 731-747.
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Roberto Gomeni, Françoise Bressolle-Gomeni & Maurizio Fava. (2016) Response Surface Analysis and Nonlinear Optimization Algorithm for Maximization of Clinical Drug Performance: Application to Extended-Release and Long-Acting Injectable Paliperidone. The Journal of Clinical Pharmacology 56:10, pages 1296-1306.
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Yu-Peng Ren, Ru-Jia Xie, Scott Marshall, Liang Li, Tian-Yan Zhou & Wei Lu. (2015) Model-based meta-analysis of the effects of non-selective and α1-selective GABAA receptor agonists in healthy volunteers. European Journal of Clinical Pharmacology 71:10, pages 1209-1221.
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N. Simon & J.-M. Azorin. (2015) Estimation rationnelle d’une posologie par modélisation pharmacométrique : application au cas d’un antipsychotique d’action prolongée. L'Encéphale 41:2, pages 159-167.
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Eleonora Marostica, Alberto Russu, Roberto Gomeni, Stefano Zamuner & Giuseppe De Nicolao. (2015) Population modelling of patient responses in antidepressant studies: A stochastic approach. Mathematical Biosciences 261, pages 37-47.
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Hyeong-Seok Lim, Kyun-Seop Bae, Jin-ah Jung, Yook-Hwan Noh, Ae-Kyung Hwang, Yeong-Woo Jo, Yong Sang Hong, KyuPyo Kim, Jae-Lyun Lee, Seong Joon Park, Jeong Eun Kim, Yoon-Koo Kang & Tae Won Kim. (2015) Predicting the Efficacy of an Oral Paclitaxel Formulation (DHP107) Through Modeling and Simulation. Clinical Therapeutics 37:2, pages 402-417.
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Celine M. Laffont, Roberto Gomeni, Bo Zheng, Christian Heidbreder, Paul J. Fudala & Azmi F. Nasser. (2015) Population pharmacokinetic modeling and simulation to guide dose selection for RBP-7000, a new sustained-release formulation of risperidone. The Journal of Clinical Pharmacology 55:1, pages 93-103.
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Eleonora Marostica, Alberto Russu, Roberto Gomeni, Stefano Zamuner & Giuseppe De Nicolao. (2014) Continuous-time Markov modelling of flexible-dose depression trials. Journal of Pharmacokinetics and Pharmacodynamics 41:6, pages 625-638.
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Eleonora Marostica, Alberto Russu, Shuying Yang, Giuseppe De Nicolao, Stefano Zamuner & Misba Beerahee. (2014) Population model of longitudinal FEV1 data in asthmatics: meta-analysis and predictability of placebo response. Journal of Pharmacokinetics and Pharmacodynamics 41:6, pages 553-569.
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Celine M. Laffont, Roberto Gomeni, Bo Zheng, Christian Heidbreder, Paul J. Fudala & Azmi F. Nasser. (2014) Population Pharmacokinetics and Prediction of Dopamine D2 Receptor Occupancy After Multiple Doses of RBP‐7000, a New Sustained‐Release Formulation of Risperidone, in Schizophrenia Patients on Stable Oral Risperidone Treatment. Clinical Pharmacokinetics 53:6, pages 533-543.
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C. Anthony Hunt, Ryan C. Kennedy, Sean H. J. Kim & Glen E. P. Ropella. (2013) Agent‐based modeling: a systematic assessment of use cases and requirements for enhancing pharmaceutical research and development productivity. WIREs Systems Biology and Medicine 5:4, pages 461-480.
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Venkatesh Pilla Reddy, Magdalena Kozielska, Ahmed Abbas Suleiman, Martin Johnson, An Vermeulen, Jing Liu, Rik de Greef, Geny M.M. Groothuis, Meindert Danhof & Johannes H. Proost. (2013) Pharmacokinetic–pharmacodynamic modeling of antipsychotic drugs in patients with schizophrenia Part I: The use of PANSS total score and clinical utility. Schizophrenia Research 146:1-3, pages 144-152.
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Venkatesh Pilla Reddy, Magdalena Kozielska, Ahmed Abbas Suleiman, Martin Johnson, An Vermeulen, Jing Liu, Rik de Greef, Geny M.M. Groothuis, Meindert Danhof & Johannes H. Proost. (2013) Pharmacokinetic–pharmacodynamic modelling of antipsychotic drugs in patients with schizophrenia: Part II: The use of subscales of the PANSS score. Schizophrenia Research 146:1-3, pages 153-161.
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Eleonora Marostica, Alberto Russu, Roberto Gomeni, Stefano Zamuner & Giuseppe De Nicolao. (2013) A PCA approach to population analysis: with application to a Phase II depression trial. Journal of Pharmacokinetics and Pharmacodynamics 40:2, pages 213-227.
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Hyeong-Seok Lim, Su Jin Kim, Yook-Hwan Noh, Byung Chul Lee, Seok-Joon Jin, Hyun Soo Park, Soohyeon Kim, In-Jin Jang & Sang Eun Kim. (2012) Exploration of Optimal Dosing Regimens of Haloperidol, a D2 Antagonist, via Modeling and Simulation Analysis in a D2 Receptor Occupancy Study. Pharmaceutical Research 30:3, pages 683-693.
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V Pilla Reddy, KJ Petersson, AA Suleiman, A Vermeulen, JH Proost & LE Friberg. (2012) Pharmacokinetic–Pharmacodynamic Modeling of Severity Levels of Extrapyramidal Side Effects With Markov Elements. CPT: Pharmacometrics & Systems Pharmacology 1:9, pages 1-9.
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A Russu, E Marostica, G De Nicolao, A C Hooker, I Poggesi, R Gomeni & S Zamuner. (2012) Joint Modeling of Efficacy, Dropout, and Tolerability in Flexible-Dose Trials: A Case Study in Depression. Clinical Pharmacology & Therapeutics 91:5, pages 863-871.
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N Goyal & R Gomeni. (2011) A Novel Metric to Assess the Clinical Utility of a Drug in the Presence of Efficacy and Dropout Information. Clinical Pharmacology & Therapeutics 91:2, pages 215-219.
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Venkatesh Pilla Reddy, Magdalena Kozielska, Martin Johnson, An Vermeulen, Rik de Greef, Jing Liu, Geny M.M. Groothuis, Meindert Danhof & Johannes H. Proost. (2011) Structural Models Describing Placebo Treatment Effects in Schizophrenia and Other Neuropsychiatric Disorders. Clinical Pharmacokinetics 50:7, pages 429-450.
Crossref
Filip De Ridder & An Vermeulen. 2011. Clinical Trial Simulations. Clinical Trial Simulations 341 357 .

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