How Is Toxicology Assessed in the Development Process?
During the development of new antibiotics, a range of toxicological assessments are conducted:
In Vitro Studies: Initial assessments are done using cellular models to evaluate cytotoxicity and mechanisms of action. In Vivo Studies: Animal studies help assess the overall toxicity profile, including acute, sub-chronic, and chronic toxicity. Clinical Trials: Human trials are crucial for evaluating the safety and efficacy in humans, focusing on dose-ranging and adverse effects.
