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Handbook of Analytical Validation
Hardcover
ISBN13: 9781498715072
Publisher: Crc Pr Inc
Published: Sep 19 2014
Pages: 226
Weight: 1.09
Height: 0.56 Width: 6.14 Depth: 9.21
Language: English
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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