Introduction

Much focus is placed on the analytical portion of drug testing. Specifically, the instruments we use for these activities often attract more attention than any other aspect of the total process. Unfortunately, this means that the pre-analytical phase of the process is often downplayed or even forgotten—that is, until one spends hours troubleshooting what seems to be an analytical problem only to trace the issue back to

From: Handbook of Drug Monitoring Methods Edited by: A. Dasgupta © Humana Press Inc., Totowa, NJ

an earlier step in the process. These steps are just as critical as those during the analysis to delivering valid results for therapeutic drug monitoring (TDM) and toxicology. Without attention to and knowledge of the conditions under which a given sample was obtained and prepared for testing, the data generated from its subsequent analysis may lead to erroneous conclusions and inappropriate, even dangerous, treatment. Thus, it is crucial that we pay close attention to the steps involved during method development or evaluation and that we implement processes to detect problems once a method is put into use. In this chapter, I will cover aspects of the pre-analytical phase key to TDM and toxicology testing and will give examples of problems that have been reported. These include issues associated with the timing of sample collection, sample containers, processing, and storage.

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