03547nam 2200685 450 991013228570332120200520144314.01-118-76310-61-118-76307-61-118-76309-2(CKB)3710000000342202(EBL)1926645(OCoLC)882620442(SSID)ssj0001400923(PQKBManifestationID)11800788(PQKBTitleCode)TC0001400923(PQKBWorkID)11344957(PQKB)11119127(PQKBManifestationID)16037974(PQKB)21316184(MiAaPQ)EBC1926645(DLC) 2014026252(Au-PeEL)EBL1926645(CaPaEBR)ebr11012473(CaONFJC)MIL708911(PPN)192131540(EXLCZ)99371000000034220220150206h20152015 uy 0engurcnu||||||||txtccrStatistical methods for evaluating safety in medical product development /editor, A. Lawrence GouldChichester, England :Wiley,2015.©20151 online resource (391 p.)Statistics in PracticeDescription based upon print version of record.1-322-77629-6 1-119-97966-8 Includes bibliographical references and index.Safety graphics / A. Lawrence Gould -- QSAR modeling : prediction of biological activity from chemical structure / Andy Liaw and Vladimir Svetnik -- Ethical and practical issues in phase I trials in healthy volunteers / Stephen Senn -- Phase I trials / A. Lawrence Gould -- Summarizing adverse event risk / A. Lawrence Gould -- Statistical analysis of recurrent adverse events / Liqun Diao, Richard J. Cook, and Ker-Ai Lee -- Cardiovascular toxicity, especially QT/QTc prolongation / Arne Ring and Robert Schall -- Hepatic toxicity / Donald C. Trost -- Neurotoxicity / A. Lawrence Gould -- Safety monitoring / Jay Herson -- Sequential testing for safety evaluation / Jie Chen -- Evaluation of post-marketing safety using spontaneous reporting databases / Ismail Ahmed, Bernard Begaud, and Pascale Tubert-Bitter / Pharmacovigilance using observational/longitudinal databases and web-based information / A. Lawrence Gould.This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literatureStatistics in practice.Clinical trialsClinical trialsStatistical methodsDrugsTestingClinical trials.Clinical trialsDrugsTesting.615.5072/4Gould Lawrence(A. Lawrence),MiAaPQMiAaPQMiAaPQBOOK9910132285703321Statistical methods for evaluating safety in medical product development2017814UNINA01078nam0 22002891i 450 RML029409820231121125738.0071905478820121121d2000 ||||0itac50 baenggbz01i xxxe z01n˜The œrights and duties of neutralsa general historyStephen C. NeffOne Odell Plaza Juris - Manchester Manchester University Press ©2000XXI, 246 p.24 cmNeutralitàFIRRMLC201469I341.6421Neff, Stephen C.RMLV189940282311ITIT-0120121121IT-FR0098 Biblioteca Area Giuridico EconomicaFR0098 RML0294098Biblioteca Area Giuridico Economica 53DSG 15/24 53VM 0000637445 VM barcode:GIU0005339. - Inventario:12510. - Fondo:Sala consultazioneVMA 2006101120121204 53Rights and duties of neutrals672858UNICAS