Publisher description for Analytical method development and validation / Michael Swartz, Ira S. Krull.


Bibliographic record and links to related information available from the Library of Congress catalog


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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.




Library of Congress subject headings for this publication:
High pressure liquid chromatography.
Pharmaceutical chemistry -- Methodology -- Evaluation.