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Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar).

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第一作者： Margherita,Torti

第一单位： Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.;San Raffaele Cassino, Rome, Italy.

作者： Margherita,Torti ^[1] ; Jhessica,Alessandroni ^[2] ; Daniele,Bravi ^[3] ; Miriam,Casali ^[3] ; Paola,Grassini ^[3] ; Chiara,Fossati ^[4] ; Cristiano,Ialongo ^[5] ; Marco,Onofrj ^[6] ; Fabiana Giada,Radicati ^[3] ; Laura,Vacca ^[7] ; Stefano,Bonassi ^[8] ; Fabrizio,Stocchi ^[9]

作者单位： Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.;San Raffaele Cassino, Rome, Italy. ^[1] BioBIM - Multidisciplinary Interistitutional BioBank San Raffaele Pisana -Research Center, Rome, Italy. ^[2] Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy. ^[3] Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.;Department of Movement, Human and Health Sciences, University of Rome "Foro Italico", Piazza Lauro de Bosis 15, Rome, Italy. ^[4] Department of Physiology and Pharmacology "Vittorio Erspamer", Sapienza University of Rome, Italy.;Department of Laboratory Medicine, Tor Vergata University of Rome, Italy. ^[5] Neurology Department, Università "G. D'Annunzio" di Chieti, Italy. ^[6] Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.;Casa di Cura Privata Policlinico (CCPP), Milan, Italy. ^[7] IRCCS San Raffaele Pisana, Clinical and Molecular Epidemiology Unit, Italy (Statistical Analysis) And Department of Human Sciences and Quality of Life Promotion, San Raffaele University, Rome, Italy. ^[8] Center for Parkinson's Disease, IRCCS San Raffaele Pisana, Rome, Italy.;San Raffaele University, Rome, Italy. ^[9]

关键词 generic formulation noninferiority originator pharmacokinetic equivalence