Practical approaches to method validation and essential instrument qualification
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| Format: | Elektronisch E-Book |
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| Sprache: | English |
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Hoboken, NJ
Wiley
2010
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| Online-Zugang: | Volltext |
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| 500 | |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 | ||
| 505 | 0 | |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 | |
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Datensatz im Suchindex
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| any_adam_object | |
| building | Verbundindex |
| bvnumber | BV041828888 |
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| 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 |
| ctrlnum | (OCoLC)681349723 (DE-599)BVBBV041828888 |
| dewey-full | 615/.1901 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.1901 |
| dewey-search | 615/.1901 |
| dewey-sort | 3615 41901 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| format | Electronic eBook |
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| illustrated | Not Illustrated |
| indexdate | 2024-12-24T04:06:26Z |
| institution | BVB |
| isbn | 9780470630716 9780470630709 9780470121948 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-027273807 |
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| publisher | Wiley |
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| spelling | Practical approaches to method validation and essential instrument qualification edited by Chung Chow Chan, Herman Lam, Xue Ming Zhang Hoboken, NJ Wiley 2010 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier Online-Ausg. 2012 erschienen Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004 "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 (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 MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Chemistry, Pharmaceutical / instrumentation Chemistry, Pharmaceutical / methods Clinical Laboratory Techniques / standards Technology, Pharmaceutical / methods Analytische Chemie gnd Qualitätssicherung gnd Medizin Drugs / Analysis / Methodology / Evaluation Laboratories / Equipment and supplies / Evaluation Laboratories / Instruments / Evaluation Analytische Chemie (DE-588)4129906-1 gnd rswk-swf Qualitätssicherung (DE-588)4126457-5 gnd rswk-swf Analytische Chemie (DE-588)4129906-1 s Qualitätssicherung (DE-588)4126457-5 s DE-604 Chan, Chung Chow Sonstige oth Lam, Herman Sonstige oth Zhang, Xue-Ming Sonstige oth https://onlinelibrary.wiley.com/doi/book/10.1002/9780470630716 Verlag Volltext |
| spellingShingle | Practical approaches to method validation and essential instrument qualification (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 MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Chemistry, Pharmaceutical / instrumentation Chemistry, Pharmaceutical / methods Clinical Laboratory Techniques / standards Technology, Pharmaceutical / methods Analytische Chemie gnd Qualitätssicherung gnd Medizin Drugs / Analysis / Methodology / Evaluation Laboratories / Equipment and supplies / Evaluation Laboratories / Instruments / Evaluation Analytische Chemie (DE-588)4129906-1 gnd Qualitätssicherung (DE-588)4126457-5 gnd |
| subject_GND | (DE-588)4129906-1 (DE-588)4126457-5 |
| title | Practical approaches to method validation and essential instrument qualification |
| title_auth | Practical approaches to method validation and essential instrument qualification |
| title_exact_search | Practical approaches to method validation and essential instrument qualification |
| title_full | Practical approaches to method validation and essential instrument qualification edited by Chung Chow Chan, Herman Lam, Xue Ming Zhang |
| title_fullStr | Practical approaches to method validation and essential instrument qualification edited by Chung Chow Chan, Herman Lam, Xue Ming Zhang |
| title_full_unstemmed | Practical approaches to method validation and essential instrument qualification edited by Chung Chow Chan, Herman Lam, Xue Ming Zhang |
| title_short | Practical approaches to method validation and essential instrument qualification |
| title_sort | practical approaches to method validation and essential instrument qualification |
| topic | MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Chemistry, Pharmaceutical / instrumentation Chemistry, Pharmaceutical / methods Clinical Laboratory Techniques / standards Technology, Pharmaceutical / methods Analytische Chemie gnd Qualitätssicherung gnd Medizin Drugs / Analysis / Methodology / Evaluation Laboratories / Equipment and supplies / Evaluation Laboratories / Instruments / Evaluation Analytische Chemie (DE-588)4129906-1 gnd Qualitätssicherung (DE-588)4126457-5 gnd |
| topic_facet | MEDICAL / Drug Guides MEDICAL / Pharmacology MEDICAL / Pharmacy MEDICAL / Nursing / Pharmacology Chemistry, Pharmaceutical / instrumentation Chemistry, Pharmaceutical / methods Clinical Laboratory Techniques / standards Technology, Pharmaceutical / methods Analytische Chemie Qualitätssicherung Medizin Drugs / Analysis / Methodology / Evaluation Laboratories / Equipment and supplies / Evaluation Laboratories / Instruments / Evaluation |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9780470630716 |
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