Analytical Method Development and Validation

By: Michael E. Swartz (Editor), Ira S. Krull (Editor)

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Paperback | 16 May 1997 | Edition Number 1

At a Glance

Paperback
98 Pages

Dimensions(cm)
21.59 x 13.97 x 0.51

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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.

Industry Reviews

." . .a useful primer-type book covering validation of analytical methods. . . .recommended." ---Analyst "Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions." ---INFORM

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