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019 _a904024916
020 _a9781118763100
_qelectronic bk.
020 _a1118763106
_qelectronic bk.
020 _z9781118763094
020 _z1118763092
020 _z9781119979661 (cloth)
020 _z9781118763070
020 _z1118763076
020 _z1119979668
020 _z9781322776293
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028 0 1 _aEB00593999
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035 _a(OCoLC)882620442
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049 _aMAIN
245 0 0 _aStatistical methods for evaluating safety in medical product development /
_ceditor Lawrence Gould, Merck Research Laboratories, USA.
264 1 _aChichester, West Sussex, UK :
_bWiley,
_c2014.
300 _a1 online resource.
336 _atext
_2rdacontent
337 _acomputer
_2rdamedia
338 _aonline resource
_2rdacarrier
490 1 _aStatistics in practice
504 _aIncludes bibliographical references and index.
505 0 _aSafety 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.
588 _aDescription based on print version record and CIP data provided by publisher.
520 _aThis 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.
650 2 _aDrug Evaluation
_xmethods.
650 2 _aClinical Trials as Topic.
650 2 _aModels, Statistical.
650 2 _aPharmacovigilance.
650 2 _aSafety Management
_xmethods.
650 2 _aTechnology, Pharmaceutical
_xstandards.
650 0 _aClinical trials
_xStatistical methods.
650 7 _aMEDICAL
_xPharmacology.
_2bisacsh
650 7 _aClinical trials
_xStatistical methods.
_2fast
_0(OCoLC)fst00864440
650 4 _aMedical.
655 4 _aElectronic books.
700 1 _aGould, Lawrence
_q(A. Lawrence),
_eeditor.
776 0 8 _iPrint version:
_tStatistical methods for evaluating safety in medical product development
_dChichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014
_z9781119979661
_w(DLC) 2014025599
830 0 _aStatistics in practice.
856 4 0 _uhttp://onlinelibrary.wiley.com/book/10.1002/9781118763070
_zWiley Online Library [Free Download only for SUST IP]
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