validation and qualification

Ludwig Huber, "Validation and Qualification in Analytical Laboratories"
Informa Healthcare; 2 edition (July 23, 2007) | ISBN:084938267X | 288 pages | PDF | 2,2 Mb

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

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John R. Crowther, "The ELISA Guidebook, 2nd edition (Methods in Molecular Biology)"
Humana Press | 2008-12-19 | ISBN: 1603272534 | 568 pages | PDF | 23,2 MB

The Enzyme Linked Immunosorbent Assay (ELISA) continues, as predicted, to be the predominant assay used in biomedical and agricultural research. While little has changed in the principles of the ELISAs used since the publication of The ELISA Guidebook, many technological advantages, including the increasing number of reagents available for exploitation and the larger spectrum of instruments to measure the coloured products of ELISAs, have greatly benefited the field. Other testing technologies using molecular techniques, predominantly the conventional and more and more often, real time PCR, are rapidly evolving to help diagnose and differentiate disease agents and identify substances present in exquisitely small amounts. The ELISA is still needed either alone in mass screening, such as serological assays, or used in tandem with molecular techniques to fully evaluate the molecular and antigenic nature of analytes.

John R. Crowther provides today’s premier practical guide to the understanding and application of ELISA. This Edition enlarges on charting methods for assessing the indirect ELISA, ruggedness and robustness of tests, aspects of kit use and validation, and internal quality control and external quality management of data. The author describes each method in great detail to ensure experimental success and includes advice on equipment choice, maintenance, and calibration. Wherever possible, helpful written explanations are provided along with copious diagrams.

With its numerous worked examples, detailed instructions, and extensive illustrations, The ELISA Guidebook, Second Edition offers a powerful synthesis of all the basic concepts and practical experimental details investigators need to understand, develop, and apply ELISA methodology successfully in day-to-day basic and clinical research.
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