Once an IND is approved, the investigational drug can proceed to clinical trials, starting with Phase I studies. These initial trials focus on safety, tolerability, and pharmacokinetics in a small group of healthy volunteers or patients. As trials progress through Phases II and III, the focus shifts to efficacy and further safety assessments.
In conclusion, toxicology plays a pivotal role in the IND process, ensuring that new drugs are safe for human testing. The comprehensive evaluation of toxicological data is essential for protecting participants in clinical trials and for the successful development of new therapeutics.
