Acute Toxicity Assay Service

Acute toxicity evaluation is one of the basic types of in vivo safety evaluation. Data from acute toxicity assay have a special role in safety evaluation, and MTD or MFD can be determined in the initial toxicity description. The data obtained in acute toxicity trials can provide a basis for the selection of dose in safe pharmacology trials and repeated administration toxicity trials. Acute toxicity assay can also be used for screening of early drug candidates or in conjunction with simple repeated administration toxicity assay. It should be noted that only data on bioavailability and systemic exposure based on exposure pathways and clinical indications can provide valuable information for acute toxicity study.

Acute toxicity evaluation of Creative Biolabs is on the basis of cognition of drug candidates, following the principle of individualized experimental scheme. According to the structure characteristics, physical property, chemical property and indication characteristics of the drug candidates, Creative Biolabs can design appropriate study scheme and conduct a comprehensive assessment of the results combined with other information.

We provide but are not limited to:

1. Approximate lethal dose method. This method is mainly used in non-rodent animal experiments.
• From the dose sequence table, the possible lethal dose range is found. Within this range, a dose is given to an animal at intervals to explorer the lowest lethal dose and the highest non-lethal dose. The dose between lowest lethal dose and the highest non-lethal dose is given to an animal.
• If no animal death occurs at the dose, the range between the dose and the lowest lethal dose is approximate lethal dose range.
• If the animal dies at the dose, the range between the dose and the highest non-lethal dose is approximate lethal dose range.
2. Maximum dose method. This method can be used for some low toxicity drugs. Under the premise of a reasonable maximum dose concentration and volume, the response of the animals is observed after single maximum dose or multiple doses within 24 hours.
3. Fixed-dose procedure. This method does not use death as the end point of observation, but the obvious signs of toxicity as the end point of evaluation.
4. Up and down method. It is currently one of the methods recommended by the OECD and EPA. Its advantage is to save experimental animals. This method can not only observe the toxicity performance, but also estimate LD₅₀ and its credibility limit, which is suitable for the drug that can cause the rapid death of animals. The method can be divided into limit assay and main assay.
• The limit assay is primarily used when data indicate that the drug candidates may be less toxic. Toxicity information can be obtained from compounds related to the candidates.
• The main assay should be conducted when there is little or no toxicity information or the subject is expected to be toxic.
5. Median lethal dose, LD₅₀.  LD₅₀ is the dose that causes the death of 50% animals under certain experimental conditions. It is a classical acute toxicity test method and the test results can be statistically processed to obtain the LD₅₀ of the drug candidates.

Creative Biolabs has many years of practical experience in acute toxicity evaluation service, carrying out a variety of in vivo drug toxicological screening services efficiently and quickly.

Advantages of acute toxicity assay service:

• Focus on innovation.
• International leading talent team.
• Build a community of interests with customers.
• To solve professional problems with professional skills.

References

1. Liu S, et al. Up-and-down designs for phase I clinical trials. Contemp Clin Trials. 2013,36(1):218‐227.
2. Stallard N, et al. The fixed-dose procedure and the acute-toxic-class method: a mathematical comparison. Hum Exp Toxicol. 1995,14(12):974‐990.

*For Research Use Only. Not for use in diagnostic procedures.

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