عنوان

Statistical methods for evaluating safety in medical product development /

1118763106

9781118763100

1118763076

1118763092

1119979668

1322776296

9781118763070

9781118763094

9781119979661 (cloth)

9781322776293

dltt

EB00593999

Recorded Books

Statistical methods for evaluating safety in medical product development /

[Book]

editor Lawrence Gould, Merck Research Laboratories, USA

1 online resource.

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

0

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

OverDrive, Inc.

A025133C-1E63-4589-BDA2-4D7FED6A46F7

Statistical methods for evaluating safety in medical product development

9781119979661

Clinical trials-- Statistical methods.

Clinical Trials as Topic.

Drug Evaluation-- methods.

Models, Statistical.

Pharmacovigilance.

Safety Management-- methods.

Technology, Pharmaceutical-- standards.

Medical.

MED-- 071000

Gould, Lawrence, (A. Lawrence)

Ohio Library and Information Network.

20160603081014.8

rda

[Book]

Y