Statistical methods for evaluating safety in medical product development
By: [edited by] Lawrence Gould
Publisher: John Wiley & Sons Inc.
Published: 2014
Place of publication: Chichester, West Sussex, United Kingdom; Hoboken
Language: eng
ISBN-13: 9781119979661
Subjects: Drug Evaluation; Methods; Clinical Trials as Topic; Statistical Models; Pharmacovigilance; Safety Management; Pharmaceutical Technology; Standards
Notes: Includes bibliographical references and index.
Table of contents: title: Safety graphics / A. Lawrence Gould; title: QSAR modeling : prediction of biological activity from chemical structure / Andy Liaw and Vladimir Svetnik; title: Ethical and practical issues in phase I trials in healthy volunteers / Stephen Senn; title: Phase I trials / A. Lawrence Gould; title: Summarizing adverse event risk / A. Lawrence Gould; title: Statistical analysis of recurrent adverse events / Liqun Diao, Richard J. Cook, and Ker-Ai Lee; title: Cardiovascular toxicity, especially QT/QTc prolongation / Arne Ring and Robert Schall; title: Hepatic toxicity / Donald C. Trost; title: Neurotoxicity / A. Lawrence Gould; title: Safety monitoring / Jay Herson; title: Sequential testing for safety evaluation / Jie Chen; title: 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.