- The Investigational New Drug (IND) application is a critical regulatory process that allows pharmaceutical companies and research institutions to transition a promising drug candidate from preclinical research to human clinical trials.
- Before a new drug can be tested in humans, regulatory agencies such as the U.S. Food and Drug Administration (FDA) must evaluate its safety, quality, and potential efficacy.
- The IND application serves as a formal request for authorization to initiate clinical studies, ensuring that experimental drugs meet rigorous scientific and ethical standards before human exposure.
