

NONMEM software assisted by Pirana, PsN, and Xpose was used to estimate population PK parameters, and R program was used to analyze and plot the results. A case study was performed with a clinical data of theophylline available in NONMEM distribution media.


Relative root mean squared error (rRMSE) and relative estimation error (REE) were used to analyze the differences between true and estimated values. A stochastic simulation and estimation (SSE) study was performed to simultaneously simulate data sets and estimate the parameters using four different methods: FOCE-I only, BAYES(C) (FOCE-I and BAYES composite method), BAYES(F) (BAYES with all true initial parameters and fixed ω 2), and BAYES only. In this study, 100 data sets were simulated with eight sampling points for each subject and with six different levels of IIV (5%, 10%, 20%, 30%, 50%, and 80%) in their PK parameter distribution. In this study, the performance of a classical first-order conditional estimation with interaction (FOCE-I) and expectation maximization (EM)-based Markov chain Monte Carlo Bayesian (BAYES) estimation methods were compared for estimating the population parameters and its distribution from data sets having a low number of subjects.

Optional 2-factor authentication is also available.Exploratory preclinical, as well as clinical trials, may involve a small number of patients, making it difficult to calculate and analyze the pharmacokinetic (PK) parameters, especially if the PK parameters show very high inter-individual variability (IIV). Great care is taken to ensure the security of these keys, using the AWS best security practices as a guide. The keys are dynamically unencrypted only as necessary to make calls to AWS services. In addition, no records of the original unencrypted keys are kept and these values are explicitly excluded from any application log files that may be generated. To protect the security of these keys, they are automatically encrypted prior to being saved in the database. The AWS credentials entered by you are stored in the Metworx database so that they can subsequently be used to access and initiate Metworx resources within your AWS account. Your AWS account allows you to create and manage company and individual level security credentials. Your individual data transmissions are encrypted while in transit using industry standard security protocols (SSL).īecause Metworx runs entirely in your AWS account, you maintain complete oversight and control of your Metworx resources. The audit is performed against the SSAE 16 standard and documented through regularly published SOC reports. AWS maintains strict physical and logical security controls in all of its operations and is audited by a highly regarded third party. Your system runs within the Amazon Web Services (AWS) cloud ecosystem.
