Single Dose Toxicity
Single dose toxicity is the toxicity produced by a pharmaceutical when it is administered in one or more doses during a period not exceeding twenty-four hours. Single dose acute toxicity studies deal with the potential adverse effects of single doses. This investigation would provide information about possible dose levels for first applications to humans, it also provides indications as to the possible effects to be expected with (accidental or intentional) over-dosing.
Creative Animodel provides single dose toxicity study services for your drug safety evaluation. We have been working in this area for decades and has extensive expertise in designing and conducting the single dose toxicity study of new pharmaceuticals. We will work closely with you to design your experiments based on the properties of your interested chemicals/pharmaceuticals and ensure to feedback the results in time to help you make decisions of the downstream studies.
At Creative Animodel, the single dose toxicity study for a pharmaceutical is evaluated in at least two mammalian species of known strain using equal numbers of both sexes prior to the first human exposure. The choice of species is shown below:
- Rodents: rats, mice and hamster
- Non-rodents: dogs, non-human primates, minipigs
The test substance is administered to animals to identify doses that causing no adverse effect and doses causing serious (life-threatening) toxicity. For substances with low toxicity, the maximum feasible dose will be performed. Our single dose toxicity studies in animals are usually performed via two different administration routes: one of them is the route intended for human administration, and the other is the intravenous administration, if feasible. Animals are usually observed for 14 days after pharmaceutical administration. All mortalities, clinical signs, time of onset, duration, and reversibility of toxicity are assessed. Gross necropsies are performed on all animals, including those sacrificed moribund, found dead, or terminated at 14 days.
Single dose toxicity studies in animal species are normally required for all pharmaceutical intended for human use. The information obtained from these testing is helpful in choosing doses for repeat-dose studies, it providing preliminary identification of target organs of toxicity, and, occasionally, revealing delayed toxicity. Single dose toxicity studies also play a role in aiding the selection of starting doses for Phase 1 clinical studies, and provide useful information relevant to acute overdosing in humans.