The physiological and health status of control animals may vary. Due to this variation, it is important to define acceptable ranges of control hematology parameters to gain a better understanding of adverse and non-adverse effects of test substances. After generating historical control data for two Wistar rat strains (RccHan™:WIST and Crl:WI(Han)) from different breeders, the data sets were statistically analyzed using Minitab®. After noticing that single outliers can affect the study control data set, the respective outliers were verified relative to the available histopathology findings, for example, inflammatory pulmonary lesions following vehicle aspiration or spontaneous sperm granuloma affecting the health status and hematology data of the respective animals. Such data points were excluded from the control data set. Comparing both data sets, it was obvious that different blood sampling and anesthesia methods as well as strain differences may result in slightly different values. After excluding the outliers, a data set from animals with presumably good health status was generated to define acceptable ranges and severity degrees. To evaluate effects, possibly influencing hematology parameters and defined acceptable ranges, selected vehicles and different study types were observed.
A novel equivalence probability weighted power prior for using historical control data in an adaptive clinical trial design: A comparison to standard methods
