PFD Releases New QbD Tools
DUBLIN, Ireland --(Business Wire)--Performance Fluid Dynamics (PFD) Limited, the leading provider of unit operation modeling software to the pharmaceutical industry, today announced the release of DynoChem 2008, with extensive new support for the Quality by Design (QbD) initiative.
"This release follows significant discussions with both customers and the FDA about QbD and the use of first principles / mechanistic modeling work to support regulatory submissions", stated Dr Joe Hannon, Chief Executive Officer.
New capabilities address the effects of uncertainty in fitted parameters on predictions and allow flexible and rapid exploration to map the multivariate design space from Excel. Parameter criticality can be quantified and all results captured in tabular and graphical format.
The release is supported by publication of a new open access White Paper on the role of mechanistic modeling in QbD, written by DynoChem's Chief Technical Officer, Alistair Gillanders.
The white paper is intended to assist companies in formulating QbD strategy and is available to download at http://www.scale-up.com/downloadwp.html and on the new Putman Media website at http://www.pharmaqbd.com.
DynoChem 2008 also opens DynoChem up to new users, by making it easy to run models in the background behind other software such as Microsoft Excel. It contains an expanded model library with over 180 templates and tools and delivers a full set of features on both Windows Vista and Office 2007.
About DynoChem
DynoChem® is productivity software for scientists and engineers working in chemical process development. DynoChem provides enterprise-wide tools for optimizing unit operations and scale-up through predictive modeling and the application of Quality-by-Design (QbD). Customers include 11 of the top 12 pharmaceutical companies and major agrochemical and specialty chemical producers.
About PFD
Performance Fluid Dynamics (PFD) Limited is the owner and developer of DynoChem®.
For further information, please visit www.scale-up.com
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