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Statistical thinking for non-statisticians in drug regulation / (Record no. 13495)

MARC details
000 -LEADER
fixed length control field 05229cam a2200769 i 4500
001 - CONTROL NUMBER
control field ocn880831304
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20171224114638.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr |||||||||||
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 140530s2015 enk ob 001 0 eng
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2014021547
040 ## - CATALOGING SOURCE
Original cataloging agency DLC
Language of cataloging eng
Description conventions rda
Transcribing agency DLC
Modifying agency YDX
-- DG1
-- N$T
-- YDXCP
-- E7B
-- RECBK
-- OCLCO
-- EBLCP
-- DEBBG
019 ## -
-- 896846731
-- 906975669
-- 927508433
-- 961566081
-- 962660732
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781118470978 (ePub)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1118470974 (ePub)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781118470992 (Adobe PDF)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1118470990 (Adobe PDF)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Cancelled/invalid ISBN 9781118470947 (cloth)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781118470961
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1118470966
028 01 - PUBLISHER NUMBER
Publisher number EB00597613
Source Recorded Books
029 1# - (OCLC)
OCLC library identifier NZ1
System control number 15894508
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV042795646
029 1# - (OCLC)
OCLC library identifier DEBBG
System control number BV043396821
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)880831304
Canceled/invalid control number (OCoLC)896846731
-- (OCoLC)906975669
-- (OCoLC)927508433
-- (OCoLC)961566081
-- (OCoLC)962660732
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 771.4
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED
Subject category code subdivision 071000
Source bisacsh
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.5/80724
Edition number 23
049 ## - LOCAL HOLDINGS (OCLC)
Holding library MAIN
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Kay, R.
Fuller form of name (Richard),
Dates associated with a name 1949-
Relator term author.
245 10 - TITLE STATEMENT
Title Statistical thinking for non-statisticians in drug regulation /
Statement of responsibility, etc Richard Kay, PhD, Statistical Consultant, RK Statistics Ltd, Honorary Visiting Professor, School of Pharmacy, Cardiff University, UK.
250 ## - EDITION STATEMENT
Edition statement Second edition.
264 #1 -
-- Chichester, West Sussex, UK ;
-- Hoboken, New Jersey :
-- Wiley Blackwell,
-- 2015.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource.
336 ## -
-- text
-- rdacontent
337 ## -
-- computer
-- rdamedia
338 ## -
-- online resource
-- rdacarrier
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Basic ideas in clinical trial design -- Sampling and inferential statistics -- Confidence intervals and p-values -- Tests for simple treatment comparisons -- Adjusting the analysis -- Regression and analysis of covariance -- Intention-to-treat and analysis sets -- Power and sample size -- Statistical significance and clinical importance -- Multiple testing -- Non-parametric and related methods -- Equivalence and non-inferiority -- The analysis of survival data -- Interim analysis and data monitoring committees -- Bayesian statistics -- Adaptive designs -- Observational studies -- Meta-analysis -- Methods for the safety analysis and safety monitoring -- Diagnosis -- The role of statistics and statisticians.
588 ## -
-- Description based on print version record and CIP data provided by publisher.
520 ## - SUMMARY, ETC.
Summary, etc Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials.It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials.Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis.Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical Trials as Topic
General subdivision methods.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Approval.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Industry.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Statistics as Topic.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Clinical trials
General subdivision Statistical methods.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs
General subdivision Testing
-- Statistical methods.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug approval
General subdivision Statistical methods.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Pharmaceutical industry
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 #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.
655 #0 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Print version:
Main entry heading Kay, R. (Richard), 1949- author.
Title Statistical thinking for non-statisticians in drug regulation
Edition Second edition.
Place, publisher, and date of publication Chichester, West Sussex, UK ; Hoboken, NJ, USA : John Wiley & Sons Inc., 2015
International Standard Book Number 9781118470947
Record control number (DLC) 2014020541
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://onlinelibrary.wiley.com/book/10.1002/9781118470961">http://onlinelibrary.wiley.com/book/10.1002/9781118470961</a>
Public note Wiley Online Library
938 ## -
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-- EBSC
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938 ## -
-- YBP Library Services
-- YANK
-- 12136913
938 ## -
-- YBP Library Services
-- YANK
-- 11071915
938 ## -
-- ebrary
-- EBRY
-- ebr10960597
938 ## -
-- Recorded Books, LLC
-- RECE
-- rbeEB00597613
938 ## -
-- YBP Library Services
-- YANK
-- 12672714
938 ## -
-- EBL - Ebook Library
-- EBLB
-- EBL4035650
994 ## -
-- 92
-- DG1

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