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Michael E. Swartz
Analytical Method Development and Validation [PDF ebook]

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Cover of Michael E. Swartz: Analytical Method Development and Validation (PDF)

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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Format PDF ● Pages 96 ● ISBN 9781482229776 ● Editor Michael E. Swartz ● Publisher CRC Press ● Published 2018 ● Downloadable 3 times ● Currency EUR ● ID 6738219 ● Copy protection Adobe DRM

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