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
General
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