Gould,A. Lawrence <br/><br/>
Statistical methods for evaluating safety in medical product development 

 - p. ;  cm. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/>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. 
<br/><br/><label>ISBN: </label>9781119979661 (cloth) 
<br/><br/><label>LCCN: </label>2014025599 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Drug Evaluation--methods.<br/>Clinical Trials as Topic.<br/>Models, Statistical.<br/>Pharmacovigilance.<br/>Safety Management--methods.<br/>Technology, Pharmaceutical--standards.
<br/><br/><label>LC Class. No.: </label>R853.C55 
<br/><br/><label>Dewey Class. No.: </label>615.50724 GAS 
<br/><br/><label>National Library of Medicine Call No.: </label>QV 771