Acute Toxicity Test on Animals

Acute toxicity assessment is one of the basic types in vivo, and drug registration often requires sensitive toxicity evaluation. The data of the compulsory toxicity test have a unique effect on safety evaluation, and MTD or MFD can determine in the initial toxicity description. The data obtained in these trials can provide a basis for the selection of dosages for safe pharmacological testing and repeated administration of toxicity tests. Acute toxicity tests can also be used for early candidate drug screening or with repeated administration of toxicity tests at the same time. It should be noted that only valuable information on acute toxicity studies can be provided for information on bioavailability and systemic exposure based on exposure and clinical indications.

Acute toxicity tests can take many forms, but their primary purpose is the same; the drug tested by the test can be tolerated at several times the clinical dose. The advantage of the screening test is that several candidate drugs can be compared simultaneously in the same trial. Tolerance indicators [such as changes in body weight and feed consumption and abnormal clinical symptoms] can provide a better reference for determining which candidate drug. At this point, the selection of animal species is generally not required to be all animal species, but at least a rodent is evaluated. It is also reasonable to assess the repeated administration of daily medication over 5 to 7 days. This contributes to the preliminary evaluation of potential changes in the clinical pathology endpoint and is also helpful for a dose selection of other toxicity test items. Still, it cannot be submitted for registration for acute toxicity tests.

For rodent trials, each dose group was sufficient for each of the five animals. The second animal species generally use 2 to 3 animals. At least 3 test dose groups should be set for the solvent control group. Dose groups can also be increased, especially in the acute toxicity test of its toxicology profile is very little knowledge of the case. After a single dose of the test sample, the body weight, feed consumption, and clinical observation room were informed of the toxicological data. Animals were given euthanasia (usually on day 14 after administration) after the specified number of days of administration. The general anatomy is intended to assess the visible lesions of tissues and organs.

But these organizations do not have any further histopathological examination in most cases. Toxicity assessment is generally limited to observing significant toxic effects such as changes in body weight, reduced feed consumption and death, morbidity, and pharmacological studies such as test specimens. The acute toxicity test data may provide a reference for the subsequent dose design of the repeated administration toxicity test.

Service Items: The LD50 or Maximal tolerance doses (MTD) of mice were investigated.

Medium Lethal Dose (LD50):  A dose that causes 50% of the animals to be killed under specific test conditions. This value is the result of statistical processing.

Maximal Tolerance Dose (MTD):  The highest dose that does not cause the death of the test animal.

Service Content:  Mice acute toxicity pre-test to determine a reasonable dose design, according to the characteristics of the drug selected to choose the appropriate route of administration, including gavage, intravenous injection, intraperitoneal injection, subcutaneous injection; some of the suspicious animals for histopathological examination.

Service Ways:  Customer provides test sample. Medicilon submits a detailed experimental report.

Service Cycle: According to the experimental program to determine, please consult.

Service charge:  According to the experimental program to determine, please consult.

Service Characteristics:  1. Pre-experiment to determine the dose and dose ratio between groups. 2. Different routes of administration to meet the needs of different test drugs.