04629cam a2200769 i 4500 ocn882620442 OCoLC 20171026135324.0 m o d cr ||||||||||| 140702s2014 enk ob 001 0 eng 2014026252 9781118763100 electronic bk. 1118763106 electronic bk. 9781118763094 1118763092 9781119979661 (cloth) 9781118763070 1118763076 1119979668 9781322776293 1322776296 EB00593999 Recorded Books CHBIS 010442316 CHVBK 334088925 NZ1 15913643 CHVBK 338338918 CHDSB 006423090 DEBBG BV042792720 DEBBG BV043396955 (OCoLC)882620442 (OCoLC)904024916 A025133C-1E63-4589-BDA2-4D7FED6A46F7 OverDrive, Inc. http://www.overdrive.com DLC eng rda DLC DG1 YDXCP N$T IDEBK OCLCF COO TEFOD RECBK OCLCO TEFOD EBLCP OCLCQ DEBBG pcc MAIN R853.C55 QV 771 MED 071000 bisacsh 615.5072/4 23 Statistical methods for evaluating safety in medical product development / editor Lawrence Gould, Merck Research Laboratories, USA. [electronic resource] Chichester, West Sussex, UK : Wiley, 2014. 1 online resource. text rdacontent computer rdamedia online resource rdacarrier Statistics in practice 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 literature. -Provides a guide to statistical methods and application in medical product development -Assists readers in undertaking design and analysis of experiments at various stages of product development -Features case studies throughout the book, as well as, SAS and R code. Description based on print version record and CIP data provided by publisher. Drug Evaluation methods. Clinical Trials as Topic. Models, Statistical. Pharmacovigilance. Safety Management methods. Technology, Pharmaceutical standards. Clinical trials Statistical methods. MEDICAL Pharmacology. bisacsh Clinical trials Statistical methods. fast (OCoLC)fst00864440 Medical. Electronic books. Gould, Lawrence (A. Lawrence), editor. Print version: Statistical methods for evaluating safety in medical product development Chichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014 9781119979661 (DLC) 2014025599 Statistics in practice. http://onlinelibrary.wiley.com/book/10.1002/9781118763070 Wiley Online Library ddc BK 207560 207560