Articles liés à Analytical Method Development and Validation

Analytical Method Development and Validation - Couverture rigide

 
9781138402560: Analytical Method Development and Validation

Synopsis

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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À propos de l'auteur

Michael E. Swartz, Ira S. Krull

À propos de la quatrième de couverture

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. This text also presents an overview of Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) regulatory guidelines.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.