00000cam a22000004i 4500 UP-99796217612712330 Buklod 20180320155721.0 m |o d | ta 180320s2014 xx d r |||| u| 9781119979661 (cloth) (iLib)UPD-00360915815 DLC DSTC rda eng DMLUC R 853 C55 S73 2015 Statistical methods for evaluating safety in medical product development [edited by] Lawrence Gould. Chichester, West Sussex, United Kingdom Hoboken John Wiley & Sons Inc. 2014. xi, 367 pages illustrations 25 cm text rdacontent unmediated rdamedia volume rdacarrier 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. Drug Evaluation methods. Clinical Trials as Topic. Models, Statistical. Gould, Lawrence (A. Lawrence) editor. FO UPD DSTC R 853 C55 2015 Book