Development And Application Of Regulalion Output For Statistical Analysis Report In Phase One Clinical Trials

Objective:During the new medicine research period,the statistical analysis of pharmacokinetics becomes more and more significant in clinical trials.Its main purpose is to evaluate the safety and efficacy of experiment medicine taken by patients/volunteers.A series of SAS macro programs are reused to realize the automatic output of PK statistical analysis tables.Methods:In the process of phase I clinical trials' statistical analysis,the most important target is reflected in the PK statistical table/figure.The PK dataset of ADPC and ADPP is conformed to CDISC ADaM data standard structure in phase I clinical trials.By SAS software,a series of general macro and main programs are completed.And the PK statistics and analysis graphics are realized by SAS GTL very easily and rapidly.This method improves the compatibility of the SAS code.At the same time,the PK Figure program is used to implement the normalized output of the PK statistical analysis graphics.It comfirms the SAS MACRO's feasibility in the instances.Results:These general-purpose macros are mainly composed of basic macro Mosto Support developed on Mosto system,HDI Support and PK Support.According to the standardized table,the automatic output of the PK statistical analysis tables is realized by the main program PK Table.Based on phase I PK data of clinical trials,the present work implements a series of basic macros and programs to output the tables and figures by SAS software and GTL procedure.It improves the efficiency of statistical analysis.Conclusions:Through SAS macro programs,the wanted PK table/figure is chieved very quickly which reduces the time of statistical analysis with high performance and improves the efficiency.Through an example of phase I clinical trials,the automation of the PK table/figure is ensured,and more satisfactory results are obtained.Adtionally,it is easy to maintain and use at any time.