Version 1.0 of PDMS is a stand-alone MS Windows 3.1 application (MS Windows 95 compliant) designed to augment and simplify the document development process existing in pharmaceutical companies today. PDMS is a full working environment and we encourage companies to invest in the future of PDMS to provide a complete document development suite.
PDMS intends to further develop the software in response to industry feedback. Future development is expected on the following guidelines:
Incorporate users current working environments. Drag and drop source files (Word, WordPerfect, Excel, Lotus) into PDMS projects. PDMS will convert the files into the document structure and produce documents that meet regulatory authority standards for document transmission. Full compliance with MERS working group (Multiagency Electronic Regulatory Submission) document transmission standard. Links from PDMS help files will be dynamic to the internet where the latest government legislation files can accessed to update current help files. Statistician (see below) PDMS has been fully tested under Windows 95. Future versions will be 32 bit and primarily designed for Windows NT. Industry requirements.
PDMS Statistician is currently in development. The statistical engine and statistical modules are designed explicitly for pharmaceutics and nothing else. On line help is provided for all routines and pharmaceutical examples are provided. Statistical routines:
Descriptive (e.g. Count, Min, Max, Range, Std dev, 95% CI etc) Normality tests Outlier tests Equal variance tests Difference means tests
Repeatability Intermediate precision Linearity Limit of quantification Limit of detection Accuracy
Statistical analysis for quantitative characteristics that are expected to decrease or increase with time. Determination of retest period and shelf life period.
The statistics modules have been designed by Prof. Danny Coomans (James Cook University of North Queensland, Australia) who has extensive experience in the pharmaceutical industry.
The draft statistics help file is included with PDMS.