Acute Toxicity Test on Animals

저자：   업로드：2017-08-29  조회수：

    Acute toxicity assessment is one of the basic types of safety assessment in vivo and drug registration often requires acute toxicity evaluation. The data of the acute toxicity test have a special effect in safety evaluation, and MTD or MFD can be determined 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 simple repeated administration of toxicity test 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, that is, 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 test. Tolerance indicators [such as changes in body weight and / or 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 evaluate the repeated administration over a period of 5 to 7 days for a given period of daily medication. This contributes to the preliminary evaluation of potential changes in the clinical pathology endpoint and is also useful for dose selection of other toxicity test items, but it cannot be submitted for registration of 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 case of 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 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 in most cases these organizations do not have any further histopathological examination. Toxicity assessment is generally limited to observing significant toxic effects such as changes in body weight, reduced feed consumption and / or 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 certain test conditions. This value is the result of statistical processing.
Maximal Tolerance Dose (MTD):  The highest dose that does not cause 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 sus

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