Applying historical data in a nonlinear mixed-effects model can reduce the number of control rats required for calculation of the relative potency of insulin analogues.

ABSTRACT: This paper examines how to reduce the number of control animals in preclinical hyperinsulemic glucose clamp studies if we make use of information on historical studies. A dataset consisting of 59 studies in rats to investigate new insulin analogues for diabetics, collected in the years 2000 to 2015, is analysed. A simulation experiment is performed based on a carefully built nonlinear mixed-effects model including historical information, comparing results (for the relative log-potency) with the standard approach ignoring previous studies. We find that by including historical information in the form of the mixed-effects model proposed, we can to remove between 23% and 51% of the control rats in the two studies looked closely upon to get the same level of precision on the relative log-potenc

SUBMITTER: Nielsen EP 

PROVIDER: S-EPMC9202954 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature