عنوان

Statistical methods for evaluating safety in medical product development /

(Number (ISBN

1118763106

(Number (ISBN

9781118763100

Erroneous ISBN

1118763076

Erroneous ISBN

1118763092

Erroneous ISBN

1119979668

Erroneous ISBN

1322776296

Erroneous ISBN

9781118763070

Erroneous ISBN

9781118763094

Erroneous ISBN

9781119979661 (cloth)

Erroneous ISBN

9781322776293

Number

dltt

Publisher's Number

EB00593999

Source

Recorded Books

Title Proper

Statistical methods for evaluating safety in medical product development /

General Material Designation

[Book]

First Statement of Responsibility

editor Lawrence Gould, Merck Research Laboratories, USA

Specific Material Designation and Extent of Item

1 online resource.

Series Title

Statistics in practice

Text of Note

Includes bibliographical references and index

Text of Note

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

Text of Note

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

Source for Acquisition/Subscription Address

OverDrive, Inc.

Stock Number

A025133C-1E63-4589-BDA2-4D7FED6A46F7

Title

Statistical methods for evaluating safety in medical product development

International Standard Book Number

9781119979661

Clinical trials-- Statistical methods.

Clinical Trials as Topic.

Drug Evaluation-- methods.

Models, Statistical.

Pharmacovigilance.

Safety Management-- methods.

Technology, Pharmaceutical-- standards.

Medical.

MED-- 071000

Number

Edition

Class number

Class number

Gould, Lawrence, (A. Lawrence)

Ohio Library and Information Network.

Date of Transaction

20160603081014.8

Cataloguing Rules (Descriptive Conventions))

rda

Electronic name

[Book]

Y