Establishment of reference intervals of biochemical analytes for healthy Chinese volunteers during the screening process in clinical pharmacology trials

Purpose Laboratory reference intervals (RIs) play a key role in clinical pharmacology trials, both in the screening process and in evaluating drug safety. However, RIs tend to be confined to the general population, and data about RIs for the trial population are limited. The purpose of this study was to determine appropriate RIs for use when screening a defined special subgroup of a healthy Chinese population in clinical pharmacology trials. Methods A total of 773 healthy Chinese volunteers (552 men and 221 women) who sought to participate in clinical pharmacology trials were included in this study. Sixteen different biochemical analytes were measured by a Beckman Coulter Unicel DxC 800 automatic analyzer. RIs were partitioned by gender using Harris and Boyd’s method and calculated using a non-parametric method. Results The RIs of 16 biochemical analytes for healthy Chinese volunteers during the screening process in clinical pharmacology trials are reported in this study. Noticeable differences between the RIs in this study and RIs provided by our laboratory or existing literature were also observed. Compared to our institutional RIs, the newly established RIs were more applicable to the current trial population. Conclusions The RIs in this study can serve as a powerful clinical tool during the screening process in clinical pharmacology trials. However, these RIs should be re-verified if any condition changes. The results also emphasize the importance re-establishing RIs which are more applicable to local trial populations.