Good Laboratory Practice Regulations, Revised and Expanded PDF Download

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249

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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g

Author: Jürg P. Seiler
Publisher: Springer Science & Business Media
ISBN: 3642868789
Category : Medical
Languages : en
Pages : 404

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Book Description
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 tests or ecotoxicology studies. At the same time the term "Good Laboratory Practice" has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547553
Category : Medical
Languages : en
Pages : 328

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Book Description
A new edition of one of Zola's lesser-known novels from the Rougon-Macquart Cycle Finding the young Angélique on their doorstep one Christmas Eve, the pious Hubert couple decide to bring her up as their own. As the girl grows up in the vicinity of the town's towering cathedral and learns her parents' trade of embroidery, she becomes increasingly fascinated by the lives of the saints, a passion fueled by her reading of the Golden Legend and other mystical Christian writings. One day love, in the shape of Félicien Hautecoeur, enters the dream world she has constructed around herself, bringing about upheaval and distress. Although it provides a detailed portrait of provincial 19th-century life and it adheres to a naturalist approach, The Dream eschews many of the characteristics of Zola's other novels of the Rougon-Macquart cycle—such as a pronounced polemical agenda or a gritty subject matter—offering instead a timeless, lyrical tale of love and innocence.

Author: Organisation for Economic Co-operation and Development
Publisher: Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
ISBN: 9789264122215
Category : Chemical industry
Languages : en
Pages :

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Book Description

Author: Allen F. Hirsch
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 248

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Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256

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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264173706
Category :
Languages : en
Pages : 42

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Book Description
These principles of corporate governance, endorsed by the OECD Council at Ministerial level in 1999, provide guidelines and standards to insure inclusion, accountability and abilit to attract capital.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN:
Category : Biological laboratories
Languages : en
Pages : 320

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Book Description
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.

Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657

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Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Author: Wenkui Li
Publisher: John Wiley & Sons
ISBN: 111867135X
Category : Science
Languages : en
Pages : 709

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Book Description
Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.