Data for: Cross study analyses of SEND data: toxicity profile classification

Large scale analysis of in vivo toxicology studies has been hindered by the lack of a standardized digital format for data analysis. The SEND standard enables the analysis of data from multiple studies performed by different laboratories. The objective of this work is to develop methods to transform, sort, and analyze data to automate cross study analysis of toxicology studies. Cross study analysis can be applied to use cases such as understanding a single compound’s toxicity profile across all studies performed and/or evaluating on- versus off-target toxicity for multiple compounds intended for the same pharmacological target. This collaborative work between BioCelerate and FDA involved development of data harmonization/transformation strategies and analytic techniques to enable cross-study analysis of both numerical and categorical SEND data. Four de-identified SEND data sets from the BioCelerate Toxicology Data Sharing module of DataCelerate® were used for the analyses. Toxicity prof..., Deidentified SEND data was donated by companies participating in BioCelerate’s Toxicology Data Sharing Initiative (TDS module in DataCelerate®).The data included 1-Month Rat and 1-Month Dog SEND datasets for two different compounds intended for the same pharmacological target. 
To facilitate cross-study analysis of toxicology studies, it is practical to categorize findings within organ systems to provide insights into target organ toxicity. In the proof-of-concept for this application, we focused on the target organs with compound-related effects, namely the kidney, liver, hematopoietic system, endocrine system, and reproductive tract (male). The body weights (BW), food and water consumption (FW), laboratory test results (LB), organ measurements (OM), and microscopic findings (MI) SEND domains were included in the analysis. Each parameter was then assigned to the relevant organ system(s) (Table 1) based on veterinary literature (Faqi 2017) (Stockham 2008), scientific literature on ..., , # Dataset for Cross Study Analyses of SEND Data: Toxicity Profile Classification

[https://doi.org/10.5061/dryad.s1rn8pkgr](https://doi.org/10.5061/dryad.s1rn8pkgr)

The data included 1-Month Rat and 1-Month Dog SEND datasets for two different compounds (Compound A and Compound B) intended for the same pharmacological target. 

## Description of the data and file structure

The files contain data from toxicology studies performed in rats and dogs to support clinical development for two different drugs intended for the same pharmacological target. The studies were donated by the pharmaceutical companies involved in development of the compounds. All proprietary and identifying information has been removed and deidentified.  

The toxicology data is organized based on the CDISC - Standard for Exchange of Nonclinical Data (SEND) data standard ([https://www.cdisc.org/standards/foundational/send/sendig-v3-1](https://www.cdisc.org/standards/foundational/send/sendig-v3-1)) and stored in .json a...,