Analytical Method Development and Validation

Hardback Published on: 29/09/2017
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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.

Publisher information

  • Publisher: Taylor & Francis Ltd
  • ISBN: 9781138402560
  • Number of pages: 96
  • Dimensions: 216 x 138 mm
  • Weight: 226g
  • Languages: English

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