Handbook of Analytical Validation

ISBN-13: 9780824706890 / Angielski / Twarda / 2012 / 220 str.

Ira S Krull

Opis

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 analytical method validation
• Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications
• Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment

Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

Recenzje

"The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."
—www.chemistryworld.org 1 November 2012 1 Chemistry World 163

Spis treści

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.

O autorze

Michael E. Swartz, Ira S. Krull