Abstract
SEND to be submitted to the U.S. FDA must be created in conformance with SENDIG v.3.1 from 2019 (for studies started after May 15, 2019 for NDA and those started after May 15, 2020 for IND). In addition to the currently-supported study types (single- and repeated-dose general toxicity and carcinogenicity studies), SENDIG v3.1 adds support for safety pharmacology studies (cardiovascular and respiratory data). Although there are only 2 domains [Cardiovascular Test Results (CV) domain and Respiratory Test Results (RE) domain] newly added to SENDIG v3.1, some data can be difficult to handle in creation of SEND datasets. For instance, when we select domains based on the controlled terminologies, the newly added domains (CV and RE) make it difficult for us to decide which domain to use to populate blood pressure, heart rate, respiratory rate and blood gas data. For another example, [--NOMDY], one of the newly-added variables in SENDIG v3.1, should be filled with a study day counted relative to the start date of dosing. However, in a study design such as a Latin square design where each animal is treated with multiple dose levels, it can be difficult to judge which study day of the dose to use to count a relative day from. This presentation will introduce points of SEND dataset creation for the safety pharmacology studies based upon the experience obtained at Ina Research Inc. and the feedback from FDA in SENDIG v3.1 Fit for Use Pilot.
