Handbook of Analytical Validation: 1st Edition (e-Book) book cover

Handbook of Analytical Validation

1st Edition

By Michael E. Swartz, Ira S. Krull

CRC Press

220 pages

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Hardback: 9780824706890
pub: 2012-04-24
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Description

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

Introduction to Analytical Method Validation. Analytical Instrument Qualification. HPLC Method Development and Optimization with Validation in Mind. Method Validation Basics. Robustness and System Suitability. Setting Specifications and Investigating Out-of-Specification Results. Validation by Type of Method. Analytical Method Transfer. Implementing New Technology in a Regulated Environment. Glossary of Terms Related to Chromatographic Method Validation.

Subject Categories

BISAC Subject Codes/Headings:
MED072000
MEDICAL / Pharmacy
SCI013010
SCIENCE / Chemistry / Analytic