| PLT
Tools: A Graphical Interface for the NONMEM System Part 11 Compliance |
NONMEM is not compliant with CFR Part 11, i.e., it provides no traceability, a feature critical to regulatory submissions. PLT Tools is designed to ensure complete traceability of a NONMEM analysis other than creation of the dataset. Features include:
1. Every file created as part of the analysis is named with an identical 13-character, 12-digit timestamp that is created at the time that a run is initiated. The format of the timestamp is YYMMDD-HHMMSS where YY is the 2-digit year, MM is the 2-digit month, DD is the 2-digit day, HH is the 2-digit hour, MM in the 2-digit minute, and SS is the 2-digit second.
2. The files created by NONMEM - FDATA, the outputfile and tables - are preserved completely unchanged.
3. PLT Tools creates a number of other files. Each of these files contains a file header indicating the time stamp described above, a text version of that timestamp, text indicating when the run was completed, and the name of the machine and user. A example of the file header appears below.
Timestamp:
071108-145352 |
4. Files created during each run by PLT Tools (TIMESTAMP refers to the 13-character timestamp described above):
Tables:
| AllRecords.TIMESTAMP.xxx* | This is a modification of the AllRecords† file in which the first line of the file ("Table #1") is deleted and all spaces are replaced with a delimiter. The file opens properly formatted for Excel. |
| FirstRecords.TIMESTAMP.xxx* | This is a modification of the FirstRecords† file in which the first line of the file ("Table #1") is deleted and all spaces are replaced with a delimiter. The file opens properly formatted for Excel. |
| Input.TIMESTAMP.xxx* | The FDATA file in which all spaces for replaced with a delimiter. |
| Halflives.TIMESTAMP.xxx* | If the model is a 1-, 2, or 3-compartment pharmacokinetic model, the user can request that table is created in which post hoc estimates for half-lives, fractional coefficients, and Vss are reported. |
* User can select
whether these files are delimited with tabs (extension: ".TAB"), commas
(extension: ".csv") or semicolons ("extension, ."csv").
† AllRecords and FirstRecords refer to files created by NONMEM's $TABLE
step in which the ALLRECORDS option has not or has been invoked.
Text Files:
| control.TIMESTAMP.txt | The unprocessed control stream preceded by the file header. This faciliates the re-use of a control stream at a later date. In addition, it facilitates comparison of control streams. |
| results.TIMESTAMP.txt | The NONMEM outputfile preceded by the file header. |
| summary.TIMESTAMP.txt | The outputfile is run through nmsee, a script that removes some of the less critical material, then preceded by the file header. |
| BriefSummary.TIMESTAMP.txt | A 1-2 page summary of the most critical elements of the NONMEM output. An example can be downloaded. |
PDF:
| Graphics-TIMESTAMP.pdf | Graphics prepared from NONMEM's tables. An example can be downloaded. Each page contains a time stamp. |
| Summary.TIMESTAMP.pdf | The summary text file described above is also saved in a PDF format in which each page contains a time stamp. |
5. In addition, certain of these files (AllRecords.TIMESTAMP.xxx, FirstRecords.TIMESTAMP.xxx, Graphics-TIMESTAMP.pdf, BriefSummary.TIMESTAMP.txt, result.TIMESTAMP.txt, and summary.TIMESTAMP.txt) are copied to a local directory (LATEST) from which they can be discarded once reviewed.
Although the steps described above should permit complete traceability of a NONMEM analysis, the user remains responsible for assuring Part 11 compliance.