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Cover of Analytical Method Development and Validation: (English)

Analytical Method Development and Validation: (English)

(Paperback)

Michael E. Swartz,

Taylor & Francis Inc (Publisher)

Published

1997

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Mathematics and Science Chemistry Analytical chemistry

By: Michael E. Swartz | Publisher: Taylor & Francis Inc | Released: 16 May 1997

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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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