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Much of the research examining the safety of pediatric vaccines is based on rodent data.
These contraindications are based on rodent data showing an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared with controls.
The finding of a statistically significant reduction in apoptotic response with age in humans supports the hypothesis set out by Polyak et al (1997) and Suh et al (2002), based on rodent data, that such a reduction may play an important role in age-associated disease processes.
For example, if the dose response function was based on rodent data, and if humans were less sensitive than rodents at some key event in the disease process, then the slope of the function could be adjusted accordingly, based on comparative species sensitivities.
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Given the lack of dose-response data for human neurotoxicity, the risk assessment was based on rodent studies and supported by primate studies of acrylamide neuropathy.
On the other hand, among the W-scoring retained candidates only 14.9% of genes was selected based on rodent models and more than half of the retained candidates (51.5%) were selected using human data (Additional file 5).
First, our observations are solely based on rodent models.
This systematic review selected 39 articles, 26 involving humans and 13 based on rodents.
A one-compartment, first-order kinetic, IV bolus model was found to be the best model for the data, and first-order elimination was assumed based on previously reported rodent data.
The starting dose was 100 mg BID, which was selected based on preclinical data in rodents (one-third of the toxic dose low and one-tenth of the dose causing severe toxicity in rat) and a preceding study in healthy male volunteers.
Our approach is novel but has the "limitation" common to most bioinformatics tools, as well as transcript annotation, in that the results are based on human and rodent data, as opposed to bovine.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com