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020 | _z9781118763070 | ||
020 | _z1118763076 | ||
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020 | _z9781322776293 | ||
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_aA025133C-1E63-4589-BDA2-4D7FED6A46F7 _bOverDrive, Inc. _nhttp://www.overdrive.com |
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_a615.5072/4 _223 |
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 |
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337 |
_acomputer _2rdamedia |
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338 |
_aonline resource _2rdacarrier |
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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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