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.
Rezensionen / Stimmen
". . .a useful primer-type book covering validation of analytical methods. . . .recommended."
---Analyst
"Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions."
---INFORM
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für höhere Schule und Studium
Undergraduate
Maße
Höhe: 222 mm
Breite: 145 mm
Dicke: 9 mm
Gewicht
ISBN-13
978-1-138-40256-0 (9781138402560)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Michael E. Swartz, Ira S. Krull
Herausgeber*in
Cambridge, Massachusetts, USA
Northeastern University, Boston, Massachusetts, USA
Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.
