![]() 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.Įxample 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 WinNonlin® 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. ![]()
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