Sandy K Weiner

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With the increasing emphasis on identification and low level control of potentially genotoxic impurities (GTIs), there has been increased use of structure-based assessments including application of computerized models. To date many publications have focused on the ability of computational models, either individually or in combination, to accurately predict(More)
The aim of this study was to evaluate a modified flow cytometric method for the quantification of micronuclei in rat bone marrow reticulocytes. The method identified uses the erythrocyte pure fraction from cellulose filtered bone marrow with slight modifications to the widely published MicroFlow(®) method developed by Litron Laboratories, Rochester, NY for(More)
The relative wealth of bacterial mutagenicity data available in the public literature means that in silico quantitative/qualitative structure activity relationship (QSAR) systems can readily be built for this endpoint. A good means of evaluating the performance of such systems is to use private unpublished data sets, which generally represent a more(More)
This study compared the attentional effects of object appearances (onsets) and disappearances (offsets) in moderately complex displays. Four experiments showed that onsets produce the inhibition of return (IOR) effect that has been found with simpler displays. In contrast, although offsets did produce inhibitory effects, these effects did not follow the(More)
At the confluence of predictive and regulatory toxicologies, negative predictions may be the thin green line that prevents populations from being exposed to harm. Here, two novel approaches to making confident and robust negative in silico predictions for mutagenicity (as defined by the Ames test) have been evaluated. Analyses of 12 data sets containing(More)
The ICH M7 guideline describes a consistent approach to identify, categorize, and control DNA reactive, mutagenic, impurities in pharmaceutical products to limit the potential carcinogenic risk related to such impurities. This paper outlines a series of principles and procedures to consider when generating (Q)SAR assessments aligned with the ICH M7(More)
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