Establishment of reference intervals of biochemical analytes for healthy Chinese volunteers during the screening process in clinical pharmacology trials
Author:
Funder
National Natural Science Foundation of China (NSFC) Grants
Zhejiang Provincial Natural Science Foundation of China Grants
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,General Medicine
Link
https://link.springer.com/content/pdf/10.1007/s00228-020-02912-1.pdf
Reference35 articles.
1. Sibille M, Deigat N, Durieu I et al (1999) Laboratory data in healthy volunteers: reference values, reference changes screening and laboratory adverse event limits in phase I clinical trials. Eur J Clin Pharmacol 55:13–19. https://doi.org/10.1007/s002280050586
2. Breithaupt-Groegler K, Coch C, Coenen M et al (2017) Who is a ‘healthy subject’?-consensus results on pivotal eligibility criteria for clinical trials. Eur J Clin Pharmacol 73:409–416. https://doi.org/10.1177/1740774517722130
3. Miller WG, Horowitz GL, Ceriotti F et al (2016) Reference intervals: strengths, weaknesses, and challenges. Clin Chem 62:916–923. https://doi.org/10.1373/clinchem.2016.256511
4. Ozarda Y (2016) Reference intervals: current status, recent developments and future considerations. Biochem Med 26:5–16. https://doi.org/10.11613/BM.2016.001
5. Friedberg RC, Souers R, Wagar EA et al (2007) The origin of reference intervals. Arch Pathol Lab Med 131:348–357. https://doi.org/10.1043/1543-2165(2007)131[348:TOORI]2.0.CO;2
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