#Winnonlin auc calculation series#

Res =sNCA(Time, Concentration, dose = 320, concUnit = 'mg/L') The interval AUC (0.5вЂ“11 hour) of the subject 8 can be calculated using the Theoph dataset with the following R script.

#Winnonlin auc calculation series#

IntAUC( ) function calculates interval (partial) AUC (from t 1 and t 2) with the given series of time and concentration. TblNCA(Theoph, key = 'Subject', colTime ='Time', colConc = 'conc', dose = 320, adm = 'Extravascular', dur = 0, doseUnit = 'mg', timeUnit = 'h', concUnit = 'mg/L', down = 'Linear') The greatest advantage of this package is that the outputs produced by this package are compatible with those of pharmacokinetic parameter (PP) TESTCD of CDISC SDTM. The adm argument can be 'Extravascular', 'Bolus', or 'Infusion' and the down argument can be either 'Linear' or 'Log'. descriptive statistics, bioequivalence test, t-test, or ANOVA). It is possible to input several keys such as subject demographics and information regarding dose, period, or sequence the result of tblNCA( ) will print the key columns and the carried keys can be further used for additional statistical analysis (i.e. In this article, we introduce two newly-developed R packages, NonCompart and ncar, that are compatible with SDTM (Study Data Tabulation Model)-formatted dataset of CDISC (Clinical Data Interchange Standards Consortium), which is the standard of documentation submitted to regulatory authorities, while providing a practical method for producing complete NCA reports.Д®xample of NonCompart package functions. Therefore, many efforts are being made to replace commercial softwares with R packages. Despite its relatively small base system compared with other commercial softwares for NCA such as WinNonlinВ® and Kinetica, R has robust functions for scientific computation and numerous add-in packages for use in various fields. R, a widely-used computer language, is a suite of libraries of statistical and mathematical computations. Particularly, AUC and C max are often accepted as the criteria for approval of bioequivalent drugs. NCA allows for estimation of various PK parameters such as AUC, peak observed drug concentration (C max), time of peak concentration (T max), and elimination half-life. NCA uses the trapezoidal rule for measurement of area under the concentration-time curve (AUC), and requires fewer assumptions than model-based analysis. PK data analysis consists of noncompartmental analysis (NCA) and nonlinear regression analysis. The aim of pharmacokinetic (PK) studies is to examine the kinetics of a drug with regard to absorption, distribution, metabolism and elimination in the body.