IND Toxicology Study Report and SEND Dataset Requirements

Abstract

Drug development is a stepwise evaluation process on both animal and human efficacy and safety information. Nonclinical toxicology studies play pivotal roles in estimating an initial safe starting dose and dose range for the human clinical trials and in identifying parameters for clinical monitoring for potential adverse effects. For an IND application, ideally it is expected that sponsors submit final, quality-assured toxicology study reports. In addition, FDA requests Standard for Exchange of Nonclinical Data (SEND) for specific types of toxicology studies and safety pharmacology studies to be submitted in the IND. There are specific acceptable submission scenarios for toxicology study reports and SEND datasets that meet FDA requirements...