The repeated dose toxicity is aimed to characterize the toxicological profile of the test compounds following repeated administration. It will provide detailed information about the potential target organs of toxicity, the exposure/response relationships, as well as the potential reversibility of toxic effects. It is an important component of the pre-clinical drug safety assessment and can support the conduct of human clinical trials and the approval of a marketing authorization of new drugs.
Creative Animodel provides repeated pre-clinical dose toxicity study for your drug safety assessment. We have an experienced team of scientists that can design and conduct your toxicity study based on the property of your drug candidate. Most importantly, we are familiar with the updated regulations and will ensure all the experiments be performed in compliant with the regulations. Additionally, the results will be feedback to you in time and we will assist you to interpret all the data.
At Creative Animodel, the duration of the repeated dose toxicity studies is based on the duration, therapeutic indication and scale of the proposed clinical trial of your interested compound. The animal toxicity studies are conducted in two mammalian species (one non-rodent), and equal numbers of male and female animals are used. The choice of the species including: (1) Rodents: rats, mice and hamster. (2) Non-rodents: dogs, non-human primates, minipigs.
The dose levels, the frequency and administration routes are based on available pharmacodynamic, pharmacokinetic and toxicological information as well as the intended clinical use. General design of our repeat dose toxicology studies are shown below:
|✓||Drug administered by relevant route(s)
- Same as clinical, possibly another route with higher bioavailability
- A high dose, a low dose and an intermediate dose will be used
|✓||Physical effects monitored
- Appearance, behavior, ambulation, cognition
- Growth, food consumption, neurological exam, water consumption
- Ophthamoscopy, body temperature, blood pressure and ECGs
|✓||Diagnostic tests conducted
- Clinical chemistry; hematology; urinalysis; biomarkers
|✓||Exposure to compound documented
- Plasma drug kinetics (e.g., Cmax, Cmin, AUC)
With the extensive experience in toxicity study, Creative Animodel will provide you the best service of the repeated toxicity study and our testing results will help you make decisions of the downstream pre-clinical testing as well as the clinical trials, and eventually contribute to the development of safe medicinal products that need repeated administration to patients.