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Analytical method validation and instrument performance verification /

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of ins...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Chan, Chung Chow
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : John Wiley & Sons, ©2004.
Temas:
Acceso en línea:Texto completo
Descripción
Sumario:Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab s.
Descripción Física:1 online resource (x, 303 pages) : illustrations
Bibliografía:Includes bibliographical references and index.
ISBN:047146371X
9780471463719
9780471463726
0471463728
0471259535
9780471259534