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Analytical Method Development and Validation

Analytical Method Development and Validation

Paperback

ChemistryGeneral Science

ISBN10: 0824701151
ISBN13: 9780824701154
Publisher: CRC Press
Published: May 16 1997
Pages: 96
Weight: 0.28
Height: 0.19 Width: 5.96 Depth: 8.18
Language: English
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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