Analytical Method Development and Validation
Editat de Michael E. Swartz, Ira S. Krullen Limba Engleză Paperback – 16 mai 1997
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Specificații
ISBN-13: 9780824701154
ISBN-10: 0824701151
Pagini: 96
Ilustrații: illustrations, bibliography
Dimensiuni: 138 x 216 x 6 mm
Greutate: 0.18 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
ISBN-10: 0824701151
Pagini: 96
Ilustrații: illustrations, bibliography
Dimensiuni: 138 x 216 x 6 mm
Greutate: 0.18 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
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Public țintă
UndergraduateCuprins
Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.
Recenzii
". . .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
---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
Notă biografică
Michael E. Swartz, Ira S. Krull
Descriere
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.