Analytical Method Development and Validation

Häftad, Engelska, 1997

Av Michael E. Swartz, Ira S. Krull

909 kr

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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.

Produktinformation

  • Utgivningsdatum1997-05-16
  • Mått138 x 216 x 6 mm
  • Vikt180 g
  • FormatHäftad
  • SpråkEngelska
  • Antal sidor96
  • FörlagTaylor & Francis Inc
  • ISBN9780824701154