Statistical methods for evaluating safety in medical product development / editor, A. Lawrence Gould, Merck Resarch Laboratories, USA.

Other author Gould, Lawrence (A. Lawrence)
Format Electronic
Publication InfoChichester, West Sussex, United Kingdom ; Hoboken : Wiley, 2015.
Descriptionxvii, 367 pages : illustrations ; 25 cm.
Supplemental ContentFull text available from Ebook Central - Academic Complete
Subjects
Drug Evaluation--methods.
Clinical Trials as Topic.
Models, Statistical.
Pharmacovigilance.
Safety Management--methods.
Technology, Pharmaceutical--standards.

SeriesStatistics in practice
Contents 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.
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2014025599
ISBN9781119979661 (cloth)