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Single dose toxicity studies provide information on acute actions or the potential effect of accidental overdose, but this information is often available from the repeat dose toxicity study, obviating the need for the acute study.
Suggestions are made to routinely conduct a single dose toxicity study patterned after the neurotoxicity study design to distinguish single dose effects and NOAELs from those resulting from multiple doses.
Study packages had single dose toxicity studies in the rodent (although there has been a recent trend to reduce the number of these studies), range-finding toxicity studies in the rodent and non-rodent (with only small numbers of the latter used) and key 2 4 week repeat dose toxicity studies in rodent (usually rat) and non-rodent (both dog and monkey).
Sprague-Dawley rats were used for an extended single dose toxicity study.
The single dose toxicity study showed that the compound was well tolerated in animals.
This type of study was "traditionally" used as main parameter for toxicity determination before human application of radiopharmaceuticals. Today, it is mainly replaced by so-called extended single dose toxicity studies.
Similar(49)
We pool safety data across disease subtypes and use a single dose-toxicity model while sharing efficacy information between disease subtypes using a hierarchical dose-response model.
Single-dose toxicity test showed no serious side effects.
The results of LD50 from single-dose toxicity test were calculated 1,500 mg/kg for males and 1,300 mg/kg for females.
The safety of rosehip extract has already been demonstrated by a single-dose toxicity test, a 30-day repeated-dose toxicity test, and an Ames test (unpublished data).
As indicated in the Position Paper, an extended single-dose toxicity study in only one appropriate mammalian species with a control group is considered sufficient to support a microdose human trial if justified by comparative in vitro data.
More suggestions(15)
single dose use
single dose dose
single dose concentration
single agent toxicity
single dose acute
single dose effects
single substance toxicity
single dose approval
single dose immunisation
single dose nevirapine
single metal toxicity
single dose treatment
single drug toxicity
single animal toxicity
single chemical toxicity
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