Analytical Method Development and Validation / Edition 1

by Michael E. Swartz, Ira S. Krull

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:	05/16/1997
Edition description:	New Edition
Pages:	96
Product dimensions:	5.44(w) x 8.50(h) x (d)

About the Author

Michael E. Swartz, Ira S. Krull

Table of Contents

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

Editorial 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

". . .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

From the Publisher