Investigations into the environmental conditions experienced during ambient sample transport: impact to dried blood spot sample shipments.

摘要

BACKGROUND: Prior to bioanalysis, sample transport and storage are critical considerations in any pharmacokinetic or toxicokinetic study design. Care must be taken to ensure the shipment is properly packaged and tracked to make certain it arrives at the desired, final destination in the appropriate timeframe, and that the integrity of the sample is not compromised. When dealing with biological specimens, environmental conditions may have a deleterious effect on the stability and conditions of the sample. RESULTS: Currently, frozen plasma or blood samples are the matrix of choice within the pharmaceutical industry for analysis within both preclinical and clinical trials. Liquid samples are shipped and received frozen and, therefore, the assumption is made that the frozen conditions are maintained throughout the entire transit process. Dried blood spot and dried matrix spot samples are becoming popular alternatives to plasma sampling in many small- and even large-molecule applications. With the implementation of dried blood spot and dried matrix spot samples, shipping and storage occurs under ambient conditions. CONCLUSION: In this article we discuss various shipping containers for these samples, illustrate the environmental extremes encountered during the shipping process, demonstrate a cost-effective method of monitoring both temperature and humidity, and discuss validation steps that may be implemented to minimize the impact of these variables on your study design.