Definition:
Non-clinical safety testing assesses the safety profile of a drug through laboratory studies using methods such as cell cultures, tissue models, or animal studies.
The goals of non–clinical safety evaluation include characterizing toxic effects, determining which organs are affected, understanding the relationship between dose and toxicity, and assessing the reversibility of these effects. These studies provide critical information about the drug’s potential toxicity and help determine safe dose ranges before clinical trials in humans. Regulatory agencies mandate non-clinical safety studies as a prerequisite for advancing drugs to clinical (human) trials.
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