ANALYTICAL METHOD DEVELOPMENT AND VALIDATION - 2ND ED

edição 1997
isbn13 9780824701154
Número de páginas 96
Peso 0,4
Autor KRULL, IRA S.
Editora T&F - TAYLOR & FRANCIS

R$ 417,26

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Descrição

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.