Good Laboratory Practice For Nonclinical Laboratory Studies
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Author | : Keystone Press |
Publisher | : |
Total Pages | : |
Release | : 1997-08 |
Genre | : |
ISBN | : 9780940701755 |
Download Good Laboratory Practice for Nonclinical Laboratory Studies Book in PDF, Epub and Kindle
Author | : Food and Drug Administration |
Publisher | : CRC Press |
Total Pages | : 54 |
Release | : 2002-09-30 |
Genre | : Medical |
ISBN | : 1135489661 |
Download Compact Regs Part 58 Book in PDF, Epub and Kindle
The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so
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 | : Interpharm |
Publisher | : CRC Press |
Total Pages | : 72 |
Release | : 2013-10-23 |
Genre | : Medical |
ISBN | : 1482207990 |
Download Compact Regs Part 58 Book in PDF, Epub and Kindle
This publication contains a verbatim reproduction of 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies.
Author | : United States. Food and Drug Administration |
Publisher | : |
Total Pages | : |
Release | : 1995 |
Genre | : |
ISBN | : 9780940701519 |
Download The Food and Drug Administration's Good Laboratory Practice for Nonclinical Laboratory Studies (GLPs). 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 | : 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 | : 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 | : 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 | : 42 |
Release | : 1992 |
Genre | : |
ISBN | : 9780940701304 |
Download The Food and Drug Administration's Good Laboratory Practice for Nonclinical Laboratory Studies (GLPs) Book in PDF, Epub and Kindle