Analytical Method Development and Validation
Forfatter: info mangler
- Format
- Bog, hardback
- Engelsk
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Leveringstid: 9-13 hverdage (Sendes fra fjernlager) Forventet levering: 05-03-2026
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Beskrivelse
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.
Detaljer
- SprogEngelsk
- Sidetal96
- Udgivelsesdato28-09-2017
- ISBN139781138402560
- Forlag Crc Press
- FormatHardback
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