Statistical methods for evaluating safety in medical product development / (Record no. 21541)

MARC details
000 -LEADER
fixed length control field 04631cam a2200793 i 4500
001 - CONTROL NUMBER
control field ocn882620442
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20230823095104.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
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008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 140702s2014 enk ob 001 0 eng
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2014026252
040 ## - CATALOGING SOURCE
Original cataloging agency DLC
Language of cataloging eng
Description conventions rda
Transcribing agency DLC
Modifying agency DG1
-- YDXCP
-- N$T
-- IDEBK
-- OCLCF
-- COO
-- TEFOD
-- RECBK
-- OCLCO
-- TEFOD
-- EBLCP
-- OCLCQ
-- DEBBG
019 ## -
-- 904024916
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781118763100
Qualifying information electronic bk.
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 1118763106
Qualifying information electronic bk.
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781118763094
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 1118763092
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781119979661 (cloth)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781118763070
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 1118763076
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 1119979668
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781322776293
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 1322776296
028 01 - PUBLISHER NUMBER
Publisher number EB00593999
Source Recorded Books
029 1# - (OCLC)
OCLC library identifier CHBIS
System control number 010442316
029 1# - (OCLC)
OCLC library identifier CHVBK
System control number 334088925
029 1# - (OCLC)
OCLC library identifier NZ1
System control number 15913643
029 1# - (OCLC)
OCLC library identifier CHVBK
System control number 338338918
029 1# - (OCLC)
OCLC library identifier CHDSB
System control number 006423090
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV042792720
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV043396955
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)882620442
Canceled/invalid control number (OCoLC)904024916
037 ## - SOURCE OF ACQUISITION
Stock number A025133C-1E63-4589-BDA2-4D7FED6A46F7
Source of stock number/acquisition OverDrive, Inc.
Note http://www.overdrive.com
042 ## - AUTHENTICATION CODE
Authentication code pcc
050 00 - LIBRARY OF CONGRESS CALL NUMBER
Classification number R853.C55
060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number QV 771
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 071000
Source bisacsh
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.5072/4
Edition number 23
049 ## - LOCAL HOLDINGS (OCLC)
Holding library MAIN
245 00 - TITLE STATEMENT
Title Statistical methods for evaluating safety in medical product development /
Statement of responsibility, etc editor Lawrence Gould, Merck Research Laboratories, USA.
264 #1 -
-- Chichester, West Sussex, UK :
-- Wiley,
-- 2014.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource.
336 ## -
-- text
-- rdacontent
337 ## -
-- computer
-- rdamedia
338 ## -
-- online resource
-- rdacarrier
490 1# - SERIES STATEMENT
Series statement Statistics in practice
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents 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.
588 ## -
-- Description based on print version record and CIP data provided by publisher.
520 ## - SUMMARY, ETC.
Summary, etc 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.
526 ## - STUDY PROGRAM INFORMATION NOTE
Department Marketing
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Evaluation
General subdivision methods.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical Trials as Topic.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Models, Statistical.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmacovigilance.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Safety Management
General subdivision methods.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Technology, Pharmaceutical
General subdivision standards.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical trials
General subdivision Statistical methods.
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element MEDICAL
General subdivision Pharmacology.
Source of heading or term bisacsh
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical trials
General subdivision Statistical methods.
Source of heading or term fast
-- (OCoLC)fst00864440
650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medical.
655 #4 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Gould, Lawrence
Fuller form of name (A. Lawrence),
Relator term editor.
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Print version:
Title Statistical methods for evaluating safety in medical product development
Place, publisher, and date of publication Chichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014
International Standard Book Number 9781119979661
Record control number (DLC) 2014025599
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE
Uniform title Statistics in practice.
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://dx.doi.org/10.1002/9781118763070">http://dx.doi.org/10.1002/9781118763070</a>
Public note Wiley Online Library
994 ## -
-- 92
-- DG1

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