• Anglický jazyk

Analytical Method Development and Validation

Autor: Ira S. Krull

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... Viac o knihe

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O knihe

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.

  • Vydavateľstvo: CRC Press
  • Rok vydania: 1997
  • Formát: Paperback
  • Rozmer: 216 x 140 mm
  • Jazyk: Anglický jazyk
  • ISBN: 9780824701154

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