Repeated Dose Toxicity Studies

Repeated dose toxicity studies is the core of non-clinical safety evaluation of drugs, it is acute toxicity, reproductive toxicity and carcinogenicity and other toxicology research, closely linked to the drug from the pharmaceutical research into clinical trials.

In the course of drug development, the purpose of the repeated dose toxicity studies is to characterize the toxic effects of the test substance by repeated administration of the animal test, to predict the possible adverse effects on the human body, to reduce the clinical trial of subjects and drugs after the use of the crowd the risk of medication. Including the following five aspects:

1. Predicting the possible adverse effects of the test substance, including the nature of adverse reactions, the degree of dose-response relationship and time-response relationship, reversibility, etc.
2. To determine the repeated administration of the test substance Toxic target organ or target tissue.
3. Presumptive clinical trial of the initial dose and repeated drug dose range.
4. Prompted clinical trials need to focus on monitoring indicators.
5. Can also be clinical trials of detoxification or rescue measures to provide a reference. It must be emphasized that the ultimate goal of long-term toxicity testing is to serve clinical trials and clinical medication.
Drug development background and basic research data are different, in the long-term toxicity test before the drug should have a comprehensive analysis of the information to determine whether the data can be achieved through repeated dose toxicity studies purposes for clinical trials and clinical medication to provide support the principle, repeated dose toxicity studies should be conducted from the point of view of ensuring the safety of clinical drugs if the available information is not yet available for long-term toxicity testing; otherwise, long-term toxicity tests are not necessary.

The development of drugs is continuous, progressive system engineering, and long-term toxicity testing is an integral part of drug development. Long-term toxicity tests cannot be separated from pharmacodynamics, pharmacokinetics, and other toxicological studies. The experimental design should take full account of the experimental design and findings of other pharmacological toxicology studies. The results of the repeated dose toxicity studies should try to prove, explain and supplement each other with other pharmacological and toxicological test results.

The fundamental contents of repeated dose toxicity studies are experiment animals, experiment time and standards, and toxicokinetics.