active pharmaceutical ingredients

How are Toxicity Studies Conducted for APIs?

Toxicity studies for APIs are conducted using in vitro (test tube or cell culture) and in vivo (animal) models. In vitro studies help in understanding cellular responses to APIs, while in vivo studies provide insights into systemic effects. These studies assess various endpoints, including acute toxicity, chronic toxicity, reproductive toxicity, and carcinogenicity. The data generated from these studies are used to predict potential human risks and establish safety guidelines.

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