2010
DOI: 10.1016/j.vascn.2010.11.097
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Can the animal model framework be applied to non-cardiovascular safety pharmacology models?

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“…Not only does this allow a more complete pharmacokinetic-pharmacodynamic (PK-PD) relationship to be developed between safety pharmacology parameters and plasma exposures, this can also help during exercises investigating the predictivity and 'translatability' of non-clinical safety pharmacology data for predicting adverse effects in humans (Valentin et al, 2009;Ewart et al, 2010Ewart et al, , 2013b. Whilst satellite animals can be used within the studies to obtain a fuller profile, this can limit data interpretation, as the PD endpoints are obtained from a different set of animals or taken at a different time point than the PK, and individual correlations of effect versus exposure relationships cannot be made (Chapman et al, 2013).…”
Section: Introductionmentioning
confidence: 99%
“…Not only does this allow a more complete pharmacokinetic-pharmacodynamic (PK-PD) relationship to be developed between safety pharmacology parameters and plasma exposures, this can also help during exercises investigating the predictivity and 'translatability' of non-clinical safety pharmacology data for predicting adverse effects in humans (Valentin et al, 2009;Ewart et al, 2010Ewart et al, , 2013b. Whilst satellite animals can be used within the studies to obtain a fuller profile, this can limit data interpretation, as the PD endpoints are obtained from a different set of animals or taken at a different time point than the PK, and individual correlations of effect versus exposure relationships cannot be made (Chapman et al, 2013).…”
Section: Introductionmentioning
confidence: 99%