Good Laboratory Practice

the Why and the How

Jürg P. Seiler (Autor)

Buch | Hardcover

XII, 424 Seiten

2005 | 2nd ed. 2005
Springer Berlin (Verlag)
978-3-540-25348-8 (ISBN)

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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.

What is Good Laboratory Practice All About?.- How is Good Laboratory Practice Regulated?.- How can Good Laboratory Practice be Introduced in a Test Facility?.- How is Compliance with Good Laboratory Practice Monitored?.

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)

Erscheint lt. Verlag	1.7.2005
Zusatzinfo	XII, 424 p.
Verlagsort	Berlin
Sprache	englisch
Maße	155 x 235 mm
Gewicht	710 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
Themenwelt	Medizin / Pharmazie ► Pharmazie
Schlagworte	Distribution • GLP • Good Laboratory Practice • OECD • OECD standards • Qualitätsmanagement • Qualitätssicherung • Quality assurance • Quality management • Standard(isierung)
ISBN-10	3-540-25348-3 / 3540253483
ISBN-13	978-3-540-25348-8 / 9783540253488
Zustand	Neuware