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《Chinese Journal of New Drugs》 2010-04
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Statistics for hematological and serum biochemical parameters in chronic toxicity studies of drug safety evaluation

ZHANG Xiao-dong,ZONG Ying,LU Guo-cai,HUANG Mao,YUAN Bo-jun(Center for New Drug Evaluation,Institute of Basic Medical Science,Second Military Medical University,Shanghai 200433,China)  
Objective: To study the statistical method in chronic toxicity studies of drug safety evaluation.Methods: We analyzed the mistakes in statistics for hematological and serum biochemical parameters in chronic toxicity studies,and offered a proper statistical method for preclinical medicine researchers.Results: Type I errors in comparing differences among groups in chronic toxicity studies of rodents were increased when t test was used.The hematological and serum biochemical parameters in chronic toxicity studies of nonrodents are repeatedly measured data.For these data,Mauchly′s test of sphericity was used to judge whether there were relations.Then,repeated measures analysis of variance was used to compare differences among groups and in different measure time.Conclusion: Analysis of variance should be taken for multiple comparisons in chronic toxicity studies of rodents.Repeated measures analysis of variance is suitable for variance analysis of hematological and serum biochemical parameters in chronic toxicity studies of nonrodents.
【CateGory Index】: R965.1
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