Good Laboratory Practice: the Why and the How - Hardcover

Seiler, Jürg P.

Hardcover

ISBN 10: 3540253483 ISBN 13: 9783540253488

Publisher: Springer, 2005

Synopsis

After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other “test items” with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field studies or ecotoxicology studies. At the same time the term “Good Laboratory Practice” has become somewhat ofa slogan with the aim to characterise any reliably conducted laboratory work.

About this title

Review

From the reviews of the second edition:

"This second edition has clarified and expanded numerous aspects of the GLP requirements from the previous edition ... . The book is very detailed in its discussion of each section of the GLP principles and explains the meaning of each of these requirements. ... In summary, the book is of value to those individuals new to the discipline of GLP, those who require clarification on GLP requirements and those organisations implementing GLP for the first time." (T. R. Stiles, BTS Newsletter, Issue 28, 2006)

"The book delivers a comprehensive examination of the critically important regimen of GLP. For laboratory managers it is a ‘must’ for initiating or enhancing laboratory contribution to clinical and environmental studies." (Geoffrey Phillips, The Pharmaceutical Journal, 2007)

Synopsis

The second edition of this concise hands-on guide to implementing Good Laboratory Practice standards has been fully updated to include the latest changes in the regulatory framework. Particularly the areas of in vitro testing and multi-site studies have undergone considerable developments in recent years. This practice-oriented guide introduces the reader to the background, basic principles, operating procedures and OECD standards. It gives invaluable information on how to avoid pitfalls and save precious time and resources. It will be an essential acquisition for anyone concerned with modern GLP.

Edition details

• Publisher: Springer
• Publication date: 2005
• Language: English
• ISBN 10: 3540253483
• ISBN 13: 9783540253488
• Binding: Hardcover
• Edition number: 2
• Number of pages: 436