Reference Interval of Clinical Laboratory Data of Young Healthy Male Volunteer in the Phase I Clinical Study.

概要

論文の詳細を見る
For use as reference individuals, the clinical laboratory data of young healthy males was analyzed at the screening examination for a phase I study (n=204-2278) and also during placebo administration (n=58-141).The conclusions are as follows:<BR>1. Normality of the distribution pattern was not proven in 26 items out of 50 items at the screening examination. The other 24 items were proved to be of normality. The natural logarithm conversion most frequently gave the normal distribution pattern.<BR>2. The rejection rate of the twice rejection procedure for 2SD was between 6-10%, and that for 3SD was less than 4% in most subjects.<BR>3. The reference limits were coincidential between the data calculated by three parametolic methods (original data, square root and natural logarithm) and non-parametolic method independent of the distribution pattern, when the values calculated by these three methods were nearly equal.<BR>4. Significant circadian rhythm was observed in 8 items of the 15 clinical hematology data and in 16 items of the 26 biochemical data during the placebo adiministration period. A significant variation of greater than 5% was observed in 9 items: white blood cell, neutrocyte (%), lymphocyte (%), eosinophil cell, triglyceride, total-bilirubin, CPK, amylase and inorganic phosphate.
一般社団法人日本臨床薬理学会の論文