Good Laboratory Practice

Good Laboratory Practice

by Mindy J. Allport-Settle
     
 

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

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Overview

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

Product Details

ISBN-13:
9780983071914
Publisher:
PharmaLogika
Publication date:
10/18/2010
Pages:
276
Product dimensions:
6.00(w) x 9.00(h) x 0.58(d)
Age Range:
18 Years

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