Analytical Method Development and Validation

1st Edition

Michael E. Swartz, Ira S. Krull

CRC Press
Published May 16, 1997
Textbook - 96 Pages
ISBN 9780824701154 - CAT# DK1151

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Summary

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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