A Retrospective Study Of Healthy Subjects Selection Criteria

Purpose: The phase I clinical trial of new drug review all young healthy volunteers werethe laboratory indexes, by statistical analysis it is concluded that they each index of referencerange (in the95%confidence interval in terms of x±1.96s), the supplementary conforms tonow the lab itself experimental conditions, the normal reference range of upper and lowerlimits us to provide basis for make them conform to the specific conditions of the clinicallaboratory indexes in this lab, the scope of normal boundaries and provide a new clinical trialoperation specification. Through the process of drug screening phase I clinical trial subjectsand data research, the study subjects group in this laboratory scope of normal law of its ownspecific conditions, provide the basis for revision of the threshold value in this field.Method: Collect new stage I drug trials have been included in the group of researchparticipants selected cases,154cases of healthy adult men, basic situation of their bodies andthe laboratory examination indexes for statistical analysis, summarize its scope of referencewithin the95%confidence interval, which is of actual test indexes of normal reference range.Make include: Gender, nationality, age, height (cm), weight (Kg), body mass index (bmi) andprofession, body temperature (℃), pulse (times/min), respiratory (times/min), blood pressure(mmHg), blood leukocyte (10^9/L), red blood cells (10^12/L), hemoglobin (g/L), neutralcell ratio (%), lymphocyte ratio (%), monocyte rate (%), platelet count (10^9/L), urinewhite blood cells (/ul), urine red blood cells (/ul), epithelial cell count (/ul), pipe type count(/ul), bacterial count (/ul), urine white blood cells (high power field of vision)/HP, urine redblood cells (high power field of vision)/HP, urine tube type cells (macro view)/HP, uricbravery, bilirubin, ketone body, occult blood, urine protein, glucose, alanine aminotransferase(IU/L), aspertate aminotransferase (IU/L), urea nitrogen (tendency/L), creatinine (umol/L),electrocardiogram (ecg), and so on.Result: The laboratory indexes all normal cases for56cases; Abnormal laboratoryresults but without clinical significance of the number of cases of98cases; The casesincluded in the subjects was154cases. Through the statistical analysis reached theirmaximum, minimum, average, standard deviation, reference range (B) x±1.96s, and thescope ofA∪B. Conclusion: As stipulated in the current laboratory indexes to judge the person’s healthor not, the ideal healthy ratio is low, can consider to choose index slightly unusual but noclinical significance of the subjects as a phase I clinical trials in healthy subjects. The currentphase I clinical trial participants screening index reference range itself, the experiment inorder to avoid phase I clinical trial screening index provide small basis reference range ofbias.