Handbook of Analytical Validation

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Handbook of Analytical Validation image
ISBN-10:

1498715079

ISBN-13:

9781498715072

Released: Sep 19, 2014
Publisher: CRC-Press
Format: Hardcover, 226 pages
Related ISBN: 9780824706890

Description:

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, it contains practical, up-to-date guidelines for analytical method validation. It also covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment. Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as the biotech industry.

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