TY  - BOOK
AU  - Gould,Lawrence
TI  - Statistical methods for evaluating safety in medical product development
T2  - Statistics in practice
SN  - 9781118763100
AV  - R853.C55 
U1  - 615.5072/4 23
PY  - 2014///
CY  - Chichester, West Sussex, UK
PB  - Wiley
KW  - Drug Evaluation
KW  - methods
KW  - Clinical Trials as Topic
KW  - Models, Statistical
KW  - Pharmacovigilance
KW  - Safety Management
KW  - Technology, Pharmaceutical
KW  - standards
KW  - Clinical trials
KW  - Statistical methods
KW  - MEDICAL
KW  - Pharmacology
KW  - bisacsh
KW  - fast
KW  - Medical
KW  - Electronic books
N1  - 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; mkt
N2  - 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
UR  - http://dx.doi.org/10.1002/9781118763070
ER  -