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Analytical Method Development and Validation|Michael E. Swartz

Analytical Method Development and Validation

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Overview

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.

This item is Non-Returnable

Details

  • ISBN-13: 9780824701154
  • ISBN-10: 0824701151
  • Publisher: CRC Press
  • Publish Date: May 1997
  • Dimensions: 8.18 x 5.96 x 0.19 inches
  • Shipping Weight: 0.28 pounds
  • Page Count: 96

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