It is based on the principle that the individual pharmacokinetic parameters of a patient population arise from a distribution that can be described by the population mean and the interindividual variance. Database of pharmacokinetic timeseries data and parameters for. Method of variability optimization in pharmacokinetic data. For example, the halflife of some drugs, especially those that require both metabolism.
Pharmacokinetic parameters of cefuroxime lysine and cefuroxime sodium were calculated from plasma concentrationtime curves using winnonlin 5. The pharmacokinetic data included in this database are strictly from intravenous administration. Analysis of pharmacokinetic pk data is concerned with defining the relationship between the dosing regimen and the bodys exposure to drug as indicated by the concentration time curve to determine a dose. With the fit parameters task in simbiology pharmacokinetics software, you can interactively configure your parameter estimation task. The chemical and pharmacokinetic data were collected both from public databases and from the literature. Pharmacokinetics database for individualized and stratified. Noncompartmental modeling was used to estimate pharmacokinetic parameters of itraconazole. We have presented a novel webbased tool for customized pharmacokinetic simulation on the organ level. Microconstants performs compartmental modeldependent or noncompartmental modelindependent pharmacokinetic analysis, using validated phoenix winnonlin software. Ritschel is for noncompartmental evaluation of pharmacokinetic parameters. Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 52 drug compounds. Intravenous data were from rapid bolus injection or infusions. You can also identify key model variables such as the dosed and response variables.
The process of calculating an optimal dosage regimen is simplified with one custom and 15 preconfigured pharmacokinetic parameters. Alternatively, you can create a pk or pd model using the graphical, tabular, or programmatic interfaces. Using sas to create an autonomous environment for the pharmacokineticist steve prust, covance, leeds, uk abstract when analysing pharmacokinetic pk data it is necessary to combine and handle various items of data assay datetimes, dosing datetimes, concentration results, demographic data etc. The ideal model of drug behavior in a population of patients, in which each patients model parameter values are known exactly, is most closely approached mathematically by the nonparametric np approach used in the freely available pmetrics population modeling software from the usc laboratory of applied pharmacokinetics. Trend analysis of a database of intravenous pharmacokinetic parameters in humans for. The original article has been cited over 500 times. Select a pharmacokinetic model from a library, or create mechanismbased pkpd models using the interactive blockdiagram editor estimate model parameters using nonlinear regression or nlme methods explore system dynamics, using parameter sweeps and sensitivity analysis. The difficulties in building a human pharmacokinetics database are manyfold. Bioequivalence and population pharmacokinetic modeling of. Pharmacokinetic parameter an overview sciencedirect topics. The parameters of this model can then be estimated using standard nonlinear regression techniques. However for the pharmacokinetic parameters of lipoic acid, all parameters are different, pvalue software program that simulates intravenous, oral, oral cavity, ocular, intranasal and pulmonary absorption, pharmacokinetics, and pharmacodynamics in human and animals.
You can specify parameters to estimate as well as parameters for which you want to calculate random effects. We present herein a compilation and trend analysis of human i. It includes various areas like pharmacodynamics, pharmacokinetics, computational chemistry, combinatorial chemistry. This data set provides the drug metabolism scientist with a robust and accurate resource suitable for a number of applications, including in silico modeling, in. Some patientrelated factors eg, renal function, genetic makeup, sex, age can be used to predict the pharmacokinetic parameters in populations. Discuss types of pharmacokinetic studies performed in drug development provide examples of different types of pharmacokinetic studies illustrate the importance of bioequivalence studies define the role of dsi to ensure data integrity of be studies. In conclusion, the pksolver simplified the pk and pd data analysis process and its output could be generated in microsoft word in the form of an integrated report. Pharmacokinetics is the study of the time course of drug absorption, distribution, metabolism, and excretion from the body. It was designed to analyze average bioequivalence abe data from noncompartmental analysis nca to anova using lm for a 2x2x2 crossover. Our software, pharmacokinetic modeling program pkmp will support data analysis in the following key areas of drug development. Pharmacokinetics of a drug depends on patientrelated factors as well as on the drugs chemical properties. The addin program xlsimest appears as four buttons command bars in the region custom toolbars under addins tab in ms excel after a quick installation, as illustrated in figure 2. Looking for pharmacokinetics software researchgate.
Knowledge about these parameters is important in terms of providing prior estimates for bayesian population analysis, designing. Modeldependent or independent pharmacokinetic analysis. Bear beba for r this package was created by hsinya lee and yungjin lee. Pharmacokinetic parameters have been determined for 300 mgm 2 of carboplatin administered over 30 min in tumorbearing dogs. It also relates to these processes to the intensity and time course of therapeutic and adverse effects of drugs and chemicals. The area under the ct curve auc from time 0 to the last concentration time point and for infinity auc 0tlast. Pharmacokinetics is the study of the time course of drug and metabolite levels in different fluids, tissues, and excreta of the body, and of the mathematical relationships required to develop models to interpret such data. The aim in building this data set and its detailed analysis was to provide, as in the previous case published in 2008, an extended, robust, and accurate resource that could be applied by drug metabolism, clinical pharmacology, and medicinal chemistry scientists to a. Overview of pharmacokinetics clinical pharmacology msd. We also include calculated pharmacokinetic parameters for some. We produce pharmacokinetic and toxicokinetic reports to support discovery, preclinical, glp toxicology, and clinical studies. A flowchart of pharmacokinetic modeling using xlsimest is shown in figure 3.
To evaluate the program, a detailed comparison of modeling pk data using pksolver and professional pkpd software package winnonlin and scientist was performed. It takes raw data and calculates parameters such as halflife, volume, auc etc. It is a fast and functional program which features patient database support. The nonlinear mixedeffects method is depicted in figure 10. Pdf trend analysis of a database of intravenous pharmacokinetic. Halflife calculator is a tool for calculating and graphing pk parameters based on serum. Pharmacokinetic definition of pharmacokinetic by medical. The program provides pharmacokinetic researchers with a fast and easytouse tool for routine and basic pk and pd data analysis with a more userfriendly interface. Data collection of pharmacokinetic parameters for chemicals in the eutoxrisk project. The purpose of this page is to provide links to information about the discipline of pharmacokinetics and pharmacodynamics. Pharmacokinetic parameters this section describes various applications using the onecompartment open model system. Pharmacokinetic models means of expressing mathematically or quantitatively, time course of drug through out the body and compute meaningful pharmacokinetic parameters.
Precisepk is a software application for therapeutic drug monitoring and the ultimate pharmacokinetic tool for both practicing medical professionals and researchers. Simbiology pharmacokinetics software allows you to create a pk model by specifying your desired model options in the pk model wizard. There are no data included from oral, intramuscular, or any other dosing routes. Pk solver a free tool to analyse pharmacokinetic data. An ebook reader can be a software application for use on a computer such as microsofts free reader application, or a booksized computer that is used solely as a reading device such as nuvomedias rocket ebook. Model options include number of compartments, dosing type, and elimination route. A2 were calculated via vortex software version 2017. The program is designed to use the pharmacokinetic data table in the. However, due to the lack of an open database, pharmacokinetics data.
Computes standard nca parameters and summarizes them with the goal of taking in observed clinical data and providing summaries ready. In the present work, pkdb a new freely available database for pk was designed with the aim of creating robust databases for pharmacokinetic studies and in silico absorption, distribution, metabolism and excretion adme prediction. Read 36 answers by scientists with 20 recommendations from their colleagues to the question asked by roland j. The cvt database is intended to serve as a comprehensive repository for tkpk data, including published sources of cvt data, cvt. It enables rapid access to all relevant anatomical and physiological parameters for humans and the most common preclinical animal models mouse, rat, minipig, dog, and monkey that are contained in the integrated database. Links to pharmacokinetic software from other vendors.
Once this expression is defined, a number of pharmacokinetic parameters can be derived from the model, which characterize the availability of the drug in the body. Trend analysis of a database of intravenous pharmacokinetic. Database to search quickly pharmacokinetic data fa301. We report a trend analysis of human intravenous pharmacokinetic data on a data set of 52 drugs. Inputs may be entered by hand, or uploaded, and output time series data is made available in both graphical and textual. In addition, twenty frequently used pharmacokinetic functions were encoded as a macro and can be directly accessed in an excel spreadsheet. The study of pharmacokinetic properties pk is of great importance in drug discovery and development. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Our system incorporates a compartmental pk model with userspecified timing, rate parameters, and optional bolus dosing. Webpk, a webbased tool for custom pharmacokinetic simulation.
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