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Handbook of Analytical Validation de Michael E. Swartz

Handbook of Analytical Validation

Autor Michael E. Swartz, Ira S. Krull
en Limba Engleză Hardback – 24 apr 2012
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.
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Specificații

ISBN-13: 9780824706890
ISBN-10: 0824706897
Pagini: 220
Ilustrații: 51 b/w images, 42 tables and Equations - 10 or less
Dimensiuni: 156 x 234 x 18 mm
Greutate: 0.52 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Locul publicării:United States

Public țintă

Professional and Professional Practice & Development

Cuprins

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.

Recenzii

"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

Notă biografică

Michael E. Swartz, Ira S. Krull

Descriere

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well as the biotech industry.