PCModfit V7.0 with major updates from previous versions is now released (currently >5000 users). When PCModfit is opened there is now a check to ‘clean up’ the numerous graphics and results files in the Results directory if desired (only if >100 is found).
The Non-Compartmental Analysis module (NCA) has been extensively modified to calculate CL, Vss, Vd and MRT parameters in addition to the usual AUC values and t½ etc., with options for the user to define the concentration units, the dose and infusion time if relevant (the latter for calculation of MRT, CL etc.). The results are still shown in the NCA spreadsheet but now, they are also output to a detailed Excel file with descriptive stats. as well (timed and dated for a paper trail record) together with the points selected for t½ determination of each profile. At the end of a ‘Run’, the Excel file containing the results will be automatically saved (Results directory) and the user can open the file and inspect the values immediately. Pictures of the NCA plots with points selected for t½ estimates are still stored in the Results directory as .png files which can be copied or imported in to Microsoft® Word etc.
The modelling option has been extensively updated. The setting up and the graphics (fitted line and data) are now all displayed in the ‘Modelling’ Excel® spreadsheet. For setting up the ‘Control’ parameters, which was often a bit tricky, there is now a ‘Keywords’ button which shows the required layout based on the Fitting Options selected in the spreadsheet (models, algorithm, weighting etc.). The graphics are of high quality (both linear and logarithmic plots now on separate Charts within Excel®) and the number of points for the computed line can now be selected to ensure a representative line over extended time periods - useful for repeat dose fitting where the overall time can be quite long (up to 5000 max.).
There is additional help describing the models and parameters which are also shown in the spreadsheet (drop down boxes containing model numbers and what the models actually are and if user parameter starting estimates are required). The graphics files produced within Excel®, are now stored as .png and not .wmf files to improve the whole appearance. Users can now analyse up to 1000 data points per profile and up to 100 profiles in a single run (should the user be so lucky!).
When modelling is successfully completed, all of the graphs can be viewed within the spreadsheet to aid the user in deciding if it was acceptable or otherwise.
Mainly due to popular usage, the Superposition module has again been further updated by the author (now re-written in Fortran for speed) and also verified by two independent users in addition to many who have tested it out for accuracy and ease of use. In addition to being able to vary the dosing interval, users can still change each dose across the entire regimen as well (thanks to suggestions by Angus McLean, Ph.D., in the USA and Dr med. Christian de Mey from ACPS in Germany).
There are still various plots of the Superposition results together with a selection for accuracy to dictate the number of points required for each run. Using the highest accuracy, which can take some time (although the Fortran module is much quicker for longer repeat dose regimens wherein; up to 100 doses can now be defined) there can be up to 1,000,000 points generated which is getting close to the number that Excel® can handle. The author recommends a value of either 0.1 or 0.01 which is a very good compromise.
Summary Superposition plots and values for parameters such as Cmin, Cmax and AUC are still output for each dose. In addition, the user can now manually override the estimated t½ value when required (sometimes useful for sparse data but when the t½ is known) and can now add their own data points to the plots very easily (particularly good for showing pre-dose values at later time points within the repeat dosing regimen).
The ‘Time above’ a MIC has been extensively modified with more precision and parameters. There is now an option for different time values (often useful in Phase II studies) within each profile whereas previous versions only allowed the same sampling times for all data sets. This version now allows up to 100 data points per profile and up to 100 data sets to be analysed in a single run. The graphics have also been improved with an increase in speed and visual appearance with all data lines now having the same thickness.
PCModfit runs with Excel 2013/2016/2019 and other versions (for Windows 7, 8, 8.1 and 10).
The non-PC version was published in Biopharmaceutics and Drug Disposition Vol. 11, No. 6, 1990, p.477-497. The author has and is still using PCModfit for numerous Phase I and II studies for domestic and international companies.
Most of the computer source code has been rewritten since publication to ensure more accuracy and versatility. The program will only run on a local computer - not a network server and each installation has its own unique licence. PCModfit is mentioned as a reference in over 100 publications to date (ca. 50 are shown on the NCA menu item for information). The instructions for each option are shown on the individual Tabs within the Excel spreadsheet.
User licenses are free and so is the new manual (as a PDF file) in the C:\PCModfit V7.0\Manual\ directory (after installation).
The setup program is available from the menu item Download, at the top of this page where some
guidance on installation is provided.