Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards – application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories

Abstract

This article is the first of a three-part series that deals with current compliance issues/challenges for bioanalytical laboratories performing analysis for bioavailability/bioequivalence studies. Part 1 of this series provides the application of key elements from the Food and Drug Administration Good Laboratory Practices and the current Good Manufacturing Practices regulations as the framework for the implementation of sound quality systems in a bioanalytical laboratory to be in compliance with current regulatory expectations. Copyright © 2007 John Wiley & Sons, Ltd.