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Handbook of Analytical Validation

Book

Handbook of Analytical Validation

DOI link for Handbook of Analytical Validation

Handbook of Analytical Validation book

Handbook of Analytical Validation

DOI link for Handbook of Analytical Validation

Handbook of Analytical Validation book

ByMichael E. Swartz, Ira S. Krull
Edition 1st Edition
First Published 2012
eBook Published 10 May 2012
Pub. Location Boca Raton
Imprint CRC Press
DOI https://doi.org/10.1201/b12039
Pages 220
eBook ISBN 9780429132339
Subjects Bioscience, Physical Sciences
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Swartz, M.E., & Krull, I.S. (2012). Handbook of Analytical Validation (1st ed.). CRC Press. https://doi.org/10.1201/b12039

ABSTRACT

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti

TABLE OF CONTENTS

chapter 1|22 pages

Introduction to Analytical Method Validation

chapter 2|14 pages

Analytical Instrument Qualification

chapter 3|24 pages

HPLC Method Development and Optimization with Validation in Mind

chapter 4|20 pages

Method Validation Basics

chapter 5|20 pages

Robustness and System Suitability

chapter 6|18 pages

Setting Specifications and Investigating Out-of-Specification Results

chapter 7|46 pages

Validation by Type of Method

chapter 8|10 pages

Analytical Method Transfer

chapter 9|8 pages

Implementing New Technology in a Regulated Environment

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