Practical approaches to method validation and essential instrument performance verification (Record no. 114819)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03283nam a2200385 a 4500 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615/.1901 |
| 245 00 - TITLE STATEMENT | |
| Title | Practical approaches to method validation and essential instrument performance verification |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication | Hoboken, N.J. : |
| Name of publisher | Wiley, |
| Year of publication | c2010. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Number of Pages | 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. |
| 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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Drugs |
| Topical Term | Laboratories |
| Topical Term | Laboratories |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Chan, Chung Chow. |
| Personal name | Lam, Herman. |
| Personal name | Zhang, Xue-Ming. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | http://site.ebrary.com/lib/rucke/Doc?id=10469614 |
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