Statistical methods for evaluating safety in medical product development

著者

editor, A. Lawrence Gould

（Statistics in practice）

Wiley, 2015

Content Type: text (ncrcontent), Media Type: unmediated (ncrmedia), Carrier Type: volume (ncrcarrier)

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.