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Analytical Method Development and Validation - Michael E. Swartz

Analytical Method Development and Validation

By: Michael E. Swartz (Editor), Ira S. Krull (Editor)

Paperback Published: 16th May 1997
ISBN: 9780824701154
Number Of Pages: 96

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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.

Industry Reviews

." . .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

Method development, optimization and validation approaches
Method validation (USP/ICH)
System suitability
Method validation protocol
Method transfer and revalidation
Table of Contents provided by Publisher. All Rights Reserved.

ISBN: 9780824701154
ISBN-10: 0824701151
Audience: Professional
Format: Paperback
Language: English
Number Of Pages: 96
Published: 16th May 1997
Publisher: CRC PR INC
Country of Publication: US
Dimensions (cm): 20.78 x 15.14  x 0.48
Weight (kg): 0.13
Edition Number: 1

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