Cardiovascular toxicity studies are preclinical studies that are conducted to evaluate the potential adverse effects of a substance on the cardiovascular system. These studies are typically conducted in laboratory animals, such as rats, mice, or dogs, to assess the safety of a drug or other substance before testing in humans.
The primary objective of cardiovascular toxicity studies is to identify any potential adverse effects of the substance on cardiovascular function, including changes in blood pressure, heart rate, electrocardiogram (ECG) parameters, and histopathological changes in cardiovascular tissue. These studies can include a range of endpoints, such as hemodynamic monitoring, ECG analysis, and histopathological examination of cardiovascular tissue.
Cardiovascular toxicity studies can be further classified based on the exposure period and the endpoints evaluated:
- Acute cardiovascular toxicity studies: These studies are conducted to evaluate the potential effects of the substance on the cardiovascular system after short-term exposure, usually for a few days to a few weeks.
- Sub-chronic cardiovascular toxicity studies: These studies are conducted to evaluate the potential effects of the substance on the cardiovascular system after repeated exposure over a period of several weeks to several months.
- Chronic cardiovascular toxicity studies: These studies are conducted to evaluate the potential effects of the substance on the cardiovascular system after repeated exposure over a period of several months to several years.
The results of cardiovascular toxicity studies can help identify any potential adverse effects of the substance on the cardiovascular system, and can help inform decisions about the safety of the substance for use in humans. These studies are an important part of the preclinical safety assessment of drugs and other substances, particularly those intended for long-term use or for use in populations with a higher risk of cardiovascular toxicity.