Method On Sampling Scheme In Bioequivalence Study Of Intravenous Drug Drugs With Long Elimination Half-life

The traditional methods to estimate AUC measurement in clinical trials in Chinawhich has been using is the trapezoidal method.However, the relatively long half-livesof drugs, traditional methods have their limitations. The first is the intensity andaccuracy of the analog value contradiction of the blood points; followed by bloodpoint is too long treatment time for patients requiring long into the group of patientsunder harsh conditions.Based on the above considerations, this paper aims to explore the conditions of theone-compartment model of intravenous administration, the AUC value estimationmethod, and strive to find new blood, new simulation model is calculated. Estimatesfor the AUC and the ideal deviation does not exceed15%. Another blood collectionpoint, at the same time, minimize and early, so that one can reduce patient treatmenttime thereby reducing the patient’s inclusion criteria, on the other hand, if feasible, canmake the suffering of the patients reduce.Under the guidance of this idea, this study first established the nine kinds of bloodprogram, and then develop a new method, then the new method and conventionalmethods to estimate the AUC is worth more than nine kinds of programs. Finally, tocompare the different circumstances, the choice of blood collection methods andsimulation calculation to estimate. In general, the smaller A value, the lower estimatedthe margin of error is in experiment. If possible, design the plan should try to choosethe front position for samplingMeans of borrowed programming, procedural guarantees for the1000simulation.Strive to improve the efficiency of research to save research costs, the most importantthing is to make research results more precise.Finally, we selected several groups of experimental bioequivalence validation of theexperimental design, bioequivalence experiment on the estimation results can explainthe experimental program are working.