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Analytical Method Development and Validation / Edition 1
     

Analytical Method Development and Validation / Edition 1

by Michael E. Swartz, Ira S. Krull, Michael Swartz, Swartz Swartz
 

ISBN-10: 0824701151

ISBN-13: 9780824701154

Pub. Date: 05/28/1997

Publisher: Taylor & Francis

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

Overview

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.

Product Details

ISBN-13:
9780824701154
Publisher:
Taylor & Francis
Publication date:
05/28/1997
Edition description:
New Edition
Pages:
96
Sales rank:
1,216,341
Product dimensions:
5.50(w) x 8.50(h) x 0.40(d)

Table of Contents

Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.

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