Abstract

Integrating preclinical data into clinical trial design is pivotal for enhancing drug efficacy and safety. This approach leverages insights from in vitro studies, animal models, and pharmacokinetic/pharmacodynamic analyses to inform and optimize trial protocols. By incorporating preclinical findings, researchers can refine dosing regimens, select appropriate endpoints, and anticipate potential side effects, thereby improving the likelihood of successful outcomes and minimizing risks to participants. Despite challenges such as model relevance and data interpretation, advancements in preclinical research and technology continue to advance this integration. Ultimately, effectively utilizing preclinical data in clinical trials leads to the development of more effective and safer therapies, advancing drug development and patient care