Practical approaches to method validation and essential instrument performance verification / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang.
"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...
Saved in:
: | |
---|---|
TeilnehmendeR: | |
Year of Publication: | 2010 |
Language: | English |
Online Access: | |
Physical Description: | xiv, 399 p. :; ill. |
Notes: | Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004. |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
id |
500675009 |
---|---|
ctrlnum |
(MiAaPQ)500675009 (Au-PeEL)EBL675009 (CaPaEBR)ebr10469614 (CaONFJC)MIL288344 (OCoLC)730151616 |
collection |
bib_alma |
record_format |
marc |
spelling |
Practical approaches to method validation and essential instrument performance verification [electronic resource] / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang. Hoboken, N.J. : Wiley, c2010. xiv, 399 p. : ill. Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004. Includes bibliographical references and index. (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. "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. Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries. Drugs Analysis Methodology Evaluation. Laboratories Equipment and supplies Evaluation. Laboratories Instruments Evaluation. Electronic books. Chan, Chung Chow. Lam, Herman. Zhang, Xue-Ming. ProQuest (Firm) https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=675009 Click to View |
language |
English |
format |
Electronic eBook |
author2 |
Chan, Chung Chow. Lam, Herman. Zhang, Xue-Ming. ProQuest (Firm) |
author_facet |
Chan, Chung Chow. Lam, Herman. Zhang, Xue-Ming. ProQuest (Firm) ProQuest (Firm) |
author2_variant |
c c c cc ccc h l hl x m z xmz |
author2_role |
TeilnehmendeR TeilnehmendeR TeilnehmendeR TeilnehmendeR |
author_corporate |
ProQuest (Firm) |
author_sort |
Chan, Chung Chow. |
title |
Practical approaches to method validation and essential instrument performance verification |
spellingShingle |
Practical approaches to method validation and essential instrument performance verification (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. |
title_full |
Practical approaches to method validation and essential instrument performance verification [electronic resource] / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang. |
title_fullStr |
Practical approaches to method validation and essential instrument performance verification [electronic resource] / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang. |
title_full_unstemmed |
Practical approaches to method validation and essential instrument performance verification [electronic resource] / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang. |
title_auth |
Practical approaches to method validation and essential instrument performance verification |
title_new |
Practical approaches to method validation and essential instrument performance verification |
title_sort |
practical approaches to method validation and essential instrument performance verification |
publisher |
Wiley, |
publishDate |
2010 |
physical |
xiv, 399 p. : ill. |
contents |
(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. |
isbn |
9780470630709 (electronic bk.) |
callnumber-first |
R - Medicine |
callnumber-subject |
RS - Pharmacy |
callnumber-label |
RS189 |
callnumber-sort |
RS 3189 P66 42010 |
genre |
Electronic books. |
genre_facet |
Electronic books. |
url |
https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=675009 |
illustrated |
Illustrated |
dewey-hundreds |
600 - Technology |
dewey-tens |
610 - Medicine & health |
dewey-ones |
615 - Pharmacology & therapeutics |
dewey-full |
615/.1901 |
dewey-sort |
3615 41901 |
dewey-raw |
615/.1901 |
dewey-search |
615/.1901 |
oclc_num |
730151616 |
work_keys_str_mv |
AT chanchungchow practicalapproachestomethodvalidationandessentialinstrumentperformanceverification AT lamherman practicalapproachestomethodvalidationandessentialinstrumentperformanceverification AT zhangxueming practicalapproachestomethodvalidationandessentialinstrumentperformanceverification AT proquestfirm practicalapproachestomethodvalidationandessentialinstrumentperformanceverification |
status_str |
n |
ids_txt_mv |
(MiAaPQ)500675009 (Au-PeEL)EBL675009 (CaPaEBR)ebr10469614 (CaONFJC)MIL288344 (OCoLC)730151616 |
is_hierarchy_title |
Practical approaches to method validation and essential instrument performance verification |
author2_original_writing_str_mv |
noLinkedField noLinkedField noLinkedField noLinkedField |
_version_ |
1792330711059922944 |
fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>03387nam a2200433 a 4500</leader><controlfield tag="001">500675009</controlfield><controlfield tag="003">MiAaPQ</controlfield><controlfield tag="005">20200520144314.0</controlfield><controlfield tag="006">m o d | </controlfield><controlfield tag="007">cr cn|||||||||</controlfield><controlfield tag="008">100113s2010 njua sb 001 0 eng d</controlfield><datafield tag="010" ind1=" " ind2=" "><subfield code="z"> 2009054243</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="z">9780470121948 (hbk.)</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9780470630709 (electronic bk.)</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(MiAaPQ)500675009</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(Au-PeEL)EBL675009</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(CaPaEBR)ebr10469614</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(CaONFJC)MIL288344</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)730151616</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">MiAaPQ</subfield><subfield code="c">MiAaPQ</subfield><subfield code="d">MiAaPQ</subfield></datafield><datafield tag="050" ind1=" " ind2="4"><subfield code="a">RS189</subfield><subfield code="b">.P66 2010</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">615/.1901</subfield><subfield code="2">22</subfield></datafield><datafield tag="245" ind1="0" ind2="0"><subfield code="a">Practical approaches to method validation and essential instrument performance verification</subfield><subfield code="h">[electronic resource] /</subfield><subfield code="c">edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang.</subfield></datafield><datafield tag="260" ind1=" " ind2=" "><subfield code="a">Hoboken, N.J. :</subfield><subfield code="b">Wiley,</subfield><subfield code="c">c2010.</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">xiv, 399 p. :</subfield><subfield code="b">ill.</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004.</subfield></datafield><datafield tag="504" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references and index.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">(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.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">"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.</subfield></datafield><datafield tag="533" ind1=" " ind2=" "><subfield code="a">Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Drugs</subfield><subfield code="x">Analysis</subfield><subfield code="x">Methodology</subfield><subfield code="x">Evaluation.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Laboratories</subfield><subfield code="x">Equipment and supplies</subfield><subfield code="x">Evaluation.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Laboratories</subfield><subfield code="x">Instruments</subfield><subfield code="x">Evaluation.</subfield></datafield><datafield tag="655" ind1=" " ind2="4"><subfield code="a">Electronic books.</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Chan, Chung Chow.</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Lam, Herman.</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Zhang, Xue-Ming.</subfield></datafield><datafield tag="710" ind1="2" ind2=" "><subfield code="a">ProQuest (Firm)</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://ebookcentral.proquest.com/lib/oeawat/detail.action?docID=675009</subfield><subfield code="z">Click to View</subfield></datafield></record></collection> |