Analytical Method Development and Validation / Edition 1

Analytical Method Development and Validation / Edition 1

by Michael E. Swartz, Swartz Swartz
     
 

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… See more details below

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
Product dimensions:
5.70(w) x 8.00(h) x 0.40(d)

Meet the Author

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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