Practical approaches to method validation and essential instrument performance verification (Record no. 123298)

MARC details
000 -LEADER
fixed length control field 03333nam a2200409 a 4500
001 - CONTROL NUMBER
control field 0000134149
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20171002061243.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS
fixed length control field m u
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
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008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 100113s2010 njua sb 001 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
Canceled/invalid LC control number 2009054243
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 9780470121948 (hbk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 9780470630709 (e-book)
035 ## - SYSTEM CONTROL NUMBER
System control number (CaPaEBR)ebr10469614
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)732958459
040 ## - CATALOGING SOURCE
Original cataloging agency CaPaEBR
Transcribing agency CaPaEBR
050 14 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS189
Item number .P66 2010eb
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615/.1901
Edition number 22
245 00 - TITLE STATEMENT
Title Practical approaches to method validation and essential instrument performance verification
Medium [electronic resource] /
Statement of responsibility, etc. edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Hoboken, N.J. :
Name of publisher, distributor, etc. Wiley,
Date of publication, distribution, etc. c2010.
300 ## - PHYSICAL DESCRIPTION
Extent xiv, 399 p. :
Other physical details ill.
500 ## - GENERAL NOTE
General note Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references and index.
505 8# - FORMATTED CONTENTS NOTE
Formatted contents note (Publisher-supplied data ) Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification / Phase Appropriate Method Validation / Analytical Method Verification, Method Revalidation, and Method Transfer / Validation of PAT Applications / The Validation of Near Infrared Systems for Raw Material Identification / Cleaning Validation / Risk Based Validation of laboratory Information Management Systems (LIMS) / Performance Qualification and Verification of Balance / Performance Verification of NIR Spectrophotometers / Operational Qualification in Practice for Gas Chromatography Instruments / Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection / Instrument Qualification and Performance Verification for Particle Size Instruments / Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers / Instrument Performance Verification ? Micro Pipettes / Instrument Qualification and Performance Verification for Automated Liquid Handling Systems / Performance Qualification and Verification in Powder X-ray Diffraction.
520 ## - SUMMARY, ETC.
Summary, etc. "The objective of this book is provide information in same practical, hands-on manner as the first book "Analytical Method Validation and Instrument Performance Verification", on important, but more advance topics. It will focus on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testings. These tests will generate reliable data that is in compliance with current Good Manufacturing Practices (cGMP) and will follow Good Analytical Practices"--Provided by publisher.
533 ## - REPRODUCTION NOTE
Type of reproduction Electronic reproduction.
Place of reproduction Palo Alto, Calif. :
Agency responsible for reproduction ebrary,
Date of reproduction 2011.
Note about reproduction Available via World Wide Web.
-- Access may be limited to ebrary affiliated libraries.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drugs
General subdivision Analysis
-- Methodology
-- Evaluation.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Laboratories
General subdivision Equipment and supplies
-- Evaluation.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Laboratories
General subdivision Instruments
-- Evaluation.
655 #7 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
Source of term local
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Chan, Chung Chow.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Lam, Herman.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Zhang, Xue-Ming.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element ebrary, Inc.
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://site.ebrary.com/lib/daystar/Doc?id=10469614">http://site.ebrary.com/lib/daystar/Doc?id=10469614</a>
Public note An electronic book accessible through the World Wide Web; click to view
908 ## - PUT COMMAND PARAMETER (RLIN)
Put command parameter 170314
942 00 - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Electronic Book

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