Good Laboratory Practice Regulations Fourth Edition
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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 | : 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 | : 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 | : 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 | : 320 |
Release | : 1995 |
Genre | : Biological laboratories |
ISBN | : |
Download Good Laboratory Practice Regulations Book in PDF, Epub and Kindle
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 | : Mindy J. Allport-Settle |
Publisher | : Pharmalogika |
Total Pages | : 276 |
Release | : 2010-10 |
Genre | : Medical |
ISBN | : 9780983071914 |
Download Good Laboratory Practice Book in PDF, Epub and Kindle
This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and associated documents for pharmaceutical, biologics and medical device products nonclinical trials. Good Laboratory Practice Regulations and Guidance: * FDA Overview and Orientation * Overview of GCP and Introduction to GLP * Part I: Federal Regulations Relating to Good Laboratory Practice o Parts 58: Good Laboratory Practice for Nonclinical Laboratory Studies o 1987 Final Rule - Good Laboratory Practice Regulations * Part II: Guidance Documents o Bioresearch Monitoring Good Laboratory Practice o Good Laboratory Practices Questions and Answers * Part III: Redbook 2000 o IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies o IV.B.2 Guidelines for Reporting the Results of Toxicity Studies Reference Tools * Part IV: Combined Glossary and Index
Author | : Milton A. Anderson |
Publisher | : CRC Press |
Total Pages | : 67 |
Release | : 2002 |
Genre | : Medical |
ISBN | : 9781574911381 |
Download GLP Essentials Book in PDF, Epub and Kindle
Concise and easy to follow, this book explains the implementation of Good Laboratory Practices (GLPs). The second edition of a standard reference, GLP Essentials identifies and describes the required elements of managing a scientific study including its planning, performance, reporting, and monitoring. The author includes a brief, informative discussion of the historical development of GLPs and the rationale for establishing these requirements in the rapidly expanding scientific research and regulatory environment. Written especially for readers involved in ensuring the integrity of their scientific documentation, this book is useful for individual and group training programs.
Author | : United States. Food and Drug Administration |
Publisher | : |
Total Pages | : 15 |
Release | : 1987 |
Genre | : Laboratories |
ISBN | : |
Download Good Laboratory Practice Regulations Book in PDF, Epub and Kindle