Analytical Method Development and Validation

By: Michael E. Swartz (Editor)

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Hardcover | 28 September 2017 | Edition Number 1

At a Glance

Hardcover
96 Pages

Dimensions(cm)
40.7 x 22.3 x 1.2

Hardcover

$694.99

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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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