To assess the potential negative consequences of repeatedly administering a subject over time, repeated dose toxicity studies are utilized. Our company offers experienced repeat dose toxicity study services to our clients because the data from repeat dose toxicity testing is crucial for establishing the dose range for human trials.
With the use of repeat dose toxicity testing, which we are experts in, we help our customers advance their drug development programs by supplying them with the accurate safety test data they want. Key development decisions are heavily influenced by toxicity studies conducted throughout clinical trials, and our repeat dose toxicity experience supports this.
Service Overview
The repeat dosage toxicity research plan developed by our company is based on the pharmacodynamic (PD), pharmacokinetic (PK), and toxicological data available from prior studies and the proposed clinical usage. The normal duration of repeat dosage toxicity trials is 2 to 6 weeks. It may be beneficial and helpful to identify biomarkers and other key translational endpoints for these preclinical toxicology studies prior to entering the clinic to reduce risk.
The general principles and layout of repeat dose toxicity testing, including species choice, treatment group size, treatment duration, frequency, and route of administration, as well as the associated identification of in-life observations and endpoints based on the features and intended clinical use of your test article, are all things that our investigators are prepared to assist you with. Via our toxicology laboratory services, customers can additionally incorporate specific endpoints based on the pharmacology of your test material.
Good Laboratory Practices (GLP) are followed in our repeat dosage toxicity testing, and the results are prepared for regulatory submission.
Research Capabilities
The information generated by our study includes dose-response curves for each toxic endpoint, response to toxic metabolites formed in the organism, delayed response, cumulative effects, general characteristics of toxicity, target organs of toxicity, the boundary between toxic/non-toxic - toxic dose, information on reversibility/irreversibility of effects, and NOAEL (No Observed Adverse Effect Level) for toxicity, the NOEL (No Observed Effect Level) for toxicity.
The following are Our company's in vivo repeat dose toxicity test capabilities:
- 28-day oral toxicity study in rodents
- 90-day oral toxicity study in rodents
- 90-day oral toxicity study in non-rodents
- Dermal toxicity: 21/28 day study (rat, rabbit or guinea pig)
- Dermal toxicity: 90-day study (rat, rabbit or guinea pig)
- Inhalation toxicity: a 28-day study in rodents
- Inhalation toxicity: a 90-day study in rodents
- Chronic toxicity studies in rodents
Overall Solutions
| Project Name | Repeated Dose Toxicity Study Service |
| Service Details | To establish a precise dose after repeat dosing, repeat-dosing toxicity studies are typically carried out. The treatment protocol affects the treatment's duration and design. In our study design, 6-10 animals per group get 1-3 test doses along each route in animals of both sexes. An average of 30 animals and 30 working days are needed for the study. Furthermore offered are custom designs. |
| Deliverables | Within agreed time, we will provide the summary to experiment data and conclusions, as well as a final experiment report. |
| Cycle | Decide according to your needs. |
For more information, please feel free to contact us.
Reference
- Kabbaoui M, et al. (2017). "Acute and Sub-Chronic Toxicity Studies of The Aqueous Extract from Leaves of Cistus Ladaniferus L. in Mice and Rats." Journal of Ethnopharmacology. 209: 147-156.
Related Services
It should be noted that our service is only used for research, not for clinical use.
