Toxicological studies are essential for assessing the safety of a drug before it is approved for clinical use. These studies investigate the potential adverse effects of the active ingredient at various levels, from the whole organism to individual cells. They are conducted through various phases, including acute, subacute, and chronic toxicity studies, as well as evaluations of genotoxicity, carcinogenicity, and reproductive effects. Toxicological studies help identify and quantify potential risks, allowing for adjustments in dosage and formulations to minimize adverse effects. The information obtained is crucial for ensuring that the drug is safe for human administration and for meeting regulatory requirements.
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