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Author | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 249 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 0203911083 |
Download Good Laboratory Practice Regulations, Revised and Expanded Book in PDF, ePub and Kindle
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 | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 256 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 0824745647 |
Download Good Laboratory Practice Regulations, Third Edition, Revised and Expanded Book in PDF, ePub and Kindle
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 | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 306 |
Release | : 2007-01-19 |
Genre | : Medical |
ISBN | : 0849375843 |
Download Good Laboratory Practice Regulations Book in PDF, ePub and Kindle
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Author | : United States. Food and Drug Administration |
Publisher | : |
Total Pages | : 60 |
Release | : 1979 |
Genre | : Laboratories |
ISBN | : |
Download Good Laboratory Practice Regulations Management Briefings Book in PDF, ePub and Kindle
Author | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 264 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 9781135552503 |
Download Good Laboratory Practice Regulations, Third Edition, Revised and Expanded Book in PDF, ePub and Kindle
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 | : Jürg P. Seiler |
Publisher | : Springer Science & Business Media |
Total Pages | : 404 |
Release | : 2012-12-06 |
Genre | : Medical |
ISBN | : 3642868789 |
Download Good Laboratory Practice Book in PDF, ePub and Kindle
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 | : United States. Food and Drug Administration |
Publisher | : |
Total Pages | : 48 |
Release | : 2008 |
Genre | : Drugs |
ISBN | : |
Download Code of federal regulations Book in PDF, ePub and Kindle
Author | : Graham P. Bunn |
Publisher | : CRC Press |
Total Pages | : 179 |
Release | : 2022-12-13 |
Genre | : Medical |
ISBN | : 1000789594 |
Download Good Laboratory Practice for Nonclinical Studies Book in PDF, ePub and Kindle
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Author | : Wenkui Li |
Publisher | : John Wiley & Sons |
Total Pages | : 709 |
Release | : 2013-09-03 |
Genre | : Science |
ISBN | : 111867135X |
Download Handbook of LC-MS Bioanalysis Book in PDF, ePub and Kindle
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.
Author | : Michigan State University. Veterinary Clinical Center |
Publisher | : |
Total Pages | : 26 |
Release | : 199? |
Genre | : Veterinary laboratories |
ISBN | : |
Download Good Laboratory Practice Book in PDF, ePub and Kindle