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The objective was to estimate clinically effective doses of RBP\u20107000 based on model simulations and on the comparison with other long\u2010acting injectable antipsychotics. A population pharmacokinetic model of RBP\u20107000 was developed in 90 clinically stable schizophrenic patients having received single\/repeated doses of 60, 90, or 120\u2009mg. Model simulations were conducted to compare active moiety plasma exposure after repeated RBP\u20107000 administrations to the published data of long\u2010acting risperidone injection (Risperdal\u00ae Consta\u00ae) at 25 and 50\u2009mg, and of paliperidone palmitate (Invega\u00ae Sustenna\u00ae) at 50 and 100\u2009mg equivalent paliperidone. Predictions of dopamine D2 receptor occupancy were derived from the simulated active moiety concentrations. Simulations showed similar active moiety plasma exposure at steady\u2010state for 90\u2009mg of RBP\u20107000 and 25\u2009mg of long\u2010acting risperidone. In comparison to risperidone, RBP\u20107000 reached effective concentrations immediately after the first administration. RBP\u20107000 at the doses of 60 and 90\u2009mg provided similar active moiety plasma concentrations at steady\u2010state compared to 50 and 100\u2009mg equivalent paliperidone, respectively. These findings provide guidance for dose selection in Phase III clinical trials and suggest potential benefits for RBP\u20107000 over competitors.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcph.366","type":"journal-article","created":{"date-parts":[[2014,7,17]],"date-time":"2014-07-17T16:10:06Z","timestamp":1405613406000},"page":"93-103","source":"Crossref","is-referenced-by-count":24,"title":["Population pharmacokinetic modeling and simulation to guide dose selection for RBP\u20107000, a new sustained\u2010release formulation of risperidone"],"prefix":"10.1002","volume":"55","author":[{"given":"Celine M.","family":"Laffont","sequence":"first","affiliation":[{"name":"Pharmacometrica La Fouillade France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"Gomeni","sequence":"additional","affiliation":[{"name":"Alleantis Research Triangle Park NC 27709 USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo","family":"Zheng","sequence":"additional","affiliation":[{"name":"Reckitt Benckiser Pharmaceuticals Inc. 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