Ermer, Joachim
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Keywords: SCIENCE / Chemistry / Analytic SCI013010
- Author(s)
- Ermer, Joachim
- Miller, John H. McB.
- Publisher
- John Wiley and Sons, Inc.
- Publication year
- 2006
- Language
- en
- Edition
- 1
- Page amount
- 418 pages
- Category
- Natural Sciences
- Format
- Ebook
- eISBN (PDF)
- 9783527604470
- Printed ISBN
- 9783527312559