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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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About the Author
Michael E. Swartz, Ira S. Krull
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Analytical Method Development and Validation
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Analytical Method Development and Validation
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Taylor & Francis Inc, 1997
ISBN 10: 0824701151
ISBN 13: 9780824701154
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