Statistical methods for evaluating safety in medical product development
Gould, Lawrence (A. Lawrence)
editor.
text
bibliography
Electronic books.
enk
2014
monographic
eng
1 online resource.
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. -Provides a guide to statistical methods and application in medical product development -Assists readers in undertaking design and analysis of experiments at various stages of product development -Features case studies throughout the book, as well as, SAS and R code.
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.
editor Lawrence Gould, Merck Research Laboratories, USA.
Includes bibliographical references and index.
mkt
Drug Evaluation
methods
Clinical Trials as Topic
Models, Statistical
Pharmacovigilance
Safety Management
methods
Technology, Pharmaceutical
standards
Clinical trials
Statistical methods
MEDICAL
Pharmacology
Clinical trials
Statistical methods
Medical
R853.C55
615.5072/4
QV 771
Statistical methods for evaluating safety in medical product development
Chichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014
(DLC) 2014025599
Statistics in practice
9781118763100
1118763106
2014026252
EB00593999 Recorded Books
A025133C-1E63-4589-BDA2-4D7FED6A46F7 OverDrive, Inc.
http://dx.doi.org/10.1002/9781118763070
http://dx.doi.org/10.1002/9781118763070
DLC
140702
20230823095104.0
ocn882620442
eng