04631cam a2200793 i 4500
ocn882620442
OCoLC
20230823095104.0
m o d
cr |||||||||||
140702s2014 enk ob 001 0 eng
2014026252
DLC
eng
rda
DLC
DG1
YDXCP
N$T
IDEBK
OCLCF
COO
TEFOD
RECBK
OCLCO
TEFOD
EBLCP
OCLCQ
DEBBG
904024916
9781118763100
electronic bk.
1118763106
electronic bk.
9781118763094
1118763092
9781119979661 (cloth)
9781118763070
1118763076
1119979668
9781322776293
1322776296
EB00593999
Recorded Books
CHBIS
010442316
CHVBK
334088925
NZ1
15913643
CHVBK
338338918
CHDSB
006423090
DEBBG
BV042792720
DEBBG
BV043396955
(OCoLC)882620442
(OCoLC)904024916
A025133C-1E63-4589-BDA2-4D7FED6A46F7
OverDrive, Inc.
http://www.overdrive.com
pcc
R853.C55
QV 771
MED
071000
bisacsh
615.5072/4
23
MAIN
Statistical methods for evaluating safety in medical product development /
editor Lawrence Gould, Merck Research Laboratories, USA.
Chichester, West Sussex, UK :
Wiley,
2014.
1 online resource.
text
rdacontent
computer
rdamedia
online resource
rdacarrier
Statistics in practice
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.
Description based on print version record and CIP data provided by publisher.
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.
Drug Evaluation
methods.
Clinical Trials as Topic.
Models, Statistical.
Pharmacovigilance.
Safety Management
methods.
Technology, Pharmaceutical
standards.
Clinical trials
Statistical methods.
MEDICAL
Pharmacology.
bisacsh
Clinical trials
Statistical methods.
fast
(OCoLC)fst00864440
Medical.
Electronic books.
Gould, Lawrence
(A. Lawrence),
editor.
Print version:
Statistical methods for evaluating safety in medical product development
Chichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014
9781119979661
(DLC) 2014025599
Statistics in practice.
http://dx.doi.org/10.1002/9781118763070
Wiley Online Library
92
DG1
21541
21500
mkt