Analytical Method Development and Validation

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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Analytical Method Development and Validation 2017, CRC Press, London

ISBN-13: 9781138402560

Hardcover

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Analytical Method Development and Validation 1997, CRC Press, New York, NY

ISBN-13: 9780824701154

Trade paperback

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