The Interdisciplinary Toxicology Program at The University of Georgia is one of the primary collaborators with the Council for the Advancement of Pyrethroid Human Risk Assessment on a multi-year research effort. The overall objective of this project is to examine whether children are more sensitive to the neurological effects of pyrethroid insecticides. A number of different studies are being conducted at The University of Georgia to provide data for input into the physiologically-based pharmacokinetic models (PBPK) that are key to addressing this question. These parameterization studies include: measurement of plasma protein binding; determination of tissue:blood partition coefficients; measurement of in vivo pharmacokinetic parameters, and assessing whether pyrethroids are substrates for cellular transport systems. None of the university laboratories doing this work are true Good Laboratory Practice (GLP) certified facilities. Nonetheless, because the data are going to be used for regulatory decisions by the EPA, ensuring data quality and permitting the studies to be critically reviewed has required the Interdisciplinary Toxicology Program to embark on a broad effort to ensure that the studies are conducted in the spirit of GLP. A variety of different systems and approaches have been put into place to assure this happens. The challenges associated with this effort, as well as the approaches devised and benefits derived, will be presented.

Ensuring data quality for studies conducted in academic research laboratories

246th National Meeting (2013)

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