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Beschreibung
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.
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.
Über den Autor
Michael E. Swartz, Ira S. Krull
Inhaltsverzeichnis
Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.
Details
Erscheinungsjahr: 1997
Fachbereich: Populäre Darstellungen
Genre: Chemie, Importe
Rubrik: Naturwissenschaften & Technik
Medium: Taschenbuch
Inhalt: Einband - flex.(Paperback)
ISBN-13: 9780824701154
ISBN-10: 0824701151
Sprache: Englisch
Einband: Kartoniert / Broschiert
Autor: Swartz, Michael E.
Redaktion: Swartz, Michael E.
Krull, Ira S.
Hersteller: CRC Press
Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße: 216 x 140 x 6 mm
Von/Mit: Michael E. Swartz (u. a.)
Erscheinungsdatum: 16.05.1997
Gewicht: 0,135 kg
Artikel-ID: 128440754