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

Abstract

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.

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Acknowledgments

The authors are very grateful to Dr. Wenling Zhu for her dedicated contribution to the assessment of the health status of participants in this study. In addition, the authors are very grateful to Dr. Songxue Guo for his dedicated contribution to the English language editing on the manuscript.

Funding

This work was supported by the following grants: National Natural Science Foundation of China (NSFC) Grants 81671909, 81901958 and Zhejiang Provincial Natural Science Foundation of China Grants LY18H150004, LY19H150004, LY20H150010.

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Authors

Contributions

Conceived and designed the experiments: PZ, XL. Performed the experiments: PZ, HC, XL JL. Analyzed the data: PZ, HC. Wrote the paper: PZ, XL. Initiated and organized this project: PZ. All authors reviewed and edited the manuscript and approved the final version of the manuscript for publication.

Corresponding author

Correspondence to Ping Zhong.

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The authors declare that they have no conflict of interest.

Research involving human participants and/or animals

This study was approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.

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Informed consent was obtained from all individual participants included in the study.

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Cite this article

Zhong, P., Chen, H., Luo, X. et al. Establishment of reference intervals of biochemical analytes for healthy Chinese volunteers during the screening process in clinical pharmacology trials. Eur J Clin Pharmacol (2020). https://doi.org/10.1007/s00228-020-02912-1

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Keywords

  • Reference intervals
  • Biochemistry
  • Chinese population
  • Clinical trials