Open Access<p>Are Laboratory Parameter (Biomarker) Values Similar to the Healthy Volunteer Reference Range in Individuals with Diabetes</p>
Author(s) -
David Brott,
Michael J. Goodman,
Richard Hermann,
Isobel Anderson,
Alexandre Kiazand
Publication year - 2020
Publication title -
drug design, development and therapy
Language(s) - English
Resource type - Journals
ISSN - 1177-8881
DOI - 10.2147/dddt.s236944
Subject(s) - medicine , diabetes mellitus , population , baseline (sea) , clinical trial , biomarker , statistics , mathematics , biology , environmental health , endocrinology , biochemistry , fishery
Identification of laboratory parameter clinical safety signals depends on the terminology and scoring criteria. Grade 1 scoring criteria in the Common Terminology Criteria for Adverse Events (CTCAE) is typically based on the healthy volunteer reference range (HVRR). The objectives of this study were to determine 1) what laboratory parameters in individuals with diabetes are potentially different from the HVRR and 2) what fold change from baseline should be expected in this population.