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Cover of Analytical Method Development and Validation

Analytical Method Development and Validation

(Hardback)

Michael E. Swartz,

Taylor & Francis Ltd (Publisher)

Published

2017

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Mathematics and Science Chemistry Analytical chemistry

By: Michael E. Swartz | Publisher: Taylor & Francis Ltd | Released: 28 Sep 2017

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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.

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