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Clinical Chemistry Summary Data

DOI: https://doi.org/10.22427/NTP-DATA-500-012-006-000-4

This data collection contains a subset of the clinical chemistry summary data collected over the past 30 years (1987 – 2016) by the Division of Translational Toxicology from dose-response studies. The selection criteria were studies with a single test article, route of exposure, species, and strain. 

Individual animal data (IAD) from different dose and/or treatment groups are summarized, and statistical test results are presented. The assay names and units have been standardized. The original assay names and data are shown in the IAD Collection. The level of significance (1, 2, or blank) is displayed in “Mult Comp Signif” and “Trend Signif” for pairwise and trend tests, respectively. A brief description of the content in these two fields is given in “Mult Comp Signif Description” and “Trend Signif Description”.

Datasets with one treatment dose and a vehicle control were analyzed by the Mann-Whitney U test. The Jonckheere's trend test, followed by the Dunn or Shirley pairwise test, was applied to datasets with more than two dose groups. 

Statistical analyses and interpretation are a starting point in the assessment of clinical chemistry study results and should not be used as a primary tool to identify test article-related effects. Clinical chemistry data should be evaluated in context with all other available study data. For more information about statistical significance testing for clinical pathology in toxicology studies, please refer to the references below.

Aulbach A, Vitsky A, Arndt T, et al. Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies. Vet Clin Pathol. 2019;48:389–399. https://doi.org/10.1111/vcp.12772

Hall RL. Practical Considerations in Clinical Pathology Data Interpretation and Description: The Use of Statistics, Reference Intervals, and Severity Descriptors. Toxiol Path. 2017;45:362-365. https://doi.org/10.1177/0192623316669824

Siska W, Gupta A, Tomlinson L, Tripathi N, von Beust B. Recommendations for clinical pathology data generation, interpretation, and reporting in target animal safety studies for veterinary drug development. Int J Toxicol. 2017;36:293-302. https://doi.org/10.1177/109158181771187

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Chemical DTXSID Standard Assay Name Standard Unit Species Strain Sex Dose Dose Unit Treatment Group Type Mean SEM N Mult Comp Test Mult Comp Signif Mult Comp Signif Description Trend Test Trend Direction Trend Pvalue Trend Signif Trend Signif Description Comparator Reference Route Vehicle Time In Study Time In Study Unit Start Year DTT Publication Number Study Title Standard Study Type Standard Study Domain Data Domain CASRN Study UID Depositor Study Number Assay UID Standard Tissue Name