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Follow on Google News | Rosa Announces Publication of its PhysioPD Model Qualification Method and Series of Educational EvenSeries of Seminars and Workshops to be held in 2012 across the US and in Europe
By: Rosa & Co Mechanistic physiological modeling, like the PhysioPD approach offered by Rosa, is employed by pharmaceutical companies to support decisions at every step of the drug development pipeline. However, a method for qualifying the model is needed in order to meet future regulatory and internal scientific demands. Drawing on decades of experience, Rosa has developed a rigorous and systematic method, known as the MQM, which can fully address questions of model relevance, scope, uncertainty, variability, use of data, and consistency with both qualitative and quantitative data, so that model-based research can proceed with confidence. “A quality standard, such as the MQM, is necessary to facilitate broad-scale adoption and to strengthen the impact of mechanistic physiological modeling. A standard for judging ‘fitness for purpose’ is long overdue, and we are proud that our decades of experience in PhysioPD modeling have enabled us to lead the way with our promulgation of the MQM. Our clients are already enjoying the benefits of this standard methodology and adopting it systematically. We look forward to sharing our ideas with a broader audience in public events like the Modeling Workshop series.” said Dr. Ron Beaver, Rosa’s Founder and CEO. Rosa is offering MQM-focused educational activities in 2012 with a series of seminars, workshops, and presentations in the EU and US. The seminars will introduce the MQM’s basic principles, and the workshops will take participants step-by-step through the process of planning, building, and qualifying mechanistic physiological models for use in pharmaceutical research and development. Participants will thus be equipped to take steps toward building and/or appraising such models. This process will empower participants to ask the right questions to ensure that their models are “fit for purpose.” The first event, on Friday, March 2, 2012, will be a seminar entitled “Building Focused Models that Support Drug Development Decisions: A Model Qualification Method” sponsored by Bay Area PK/PD, an industry group in the San Francisco Bay Area (www.bapkpd.org) Subsequent workshops will be offered at the 3rd Annual World PK/PD Summit, March 27 – 29, 2012 in Boston (pkpd-summit.com) Rosa’s educational events were planned in response to three highly successful events in 2011: the ACoP in San Diego, CA, the ICBS in Heidelberg, Germany, and Rosa’s ”Impact of Modeling & Simulation in Drug Development” For more information about the MQM, additional events, or to arrange for a private workshop, please contact Rosa & Co at spagano@rosaandco.com. About Rosa Rosa informs our customer’s most critical decisions – from preclinical through clinical development – with the creation and use of mathematical models that simulate disease physiology, drug action, patient variability, and trial outcomes. To address the full spectrum of related issues, Rosa offers two customized approaches: classic pharmacokinetic/ Rosa and the Rosa logo are registered trademarks of Rosa & Co. LLC. # # # Rosa informs our customer’s most critical decisions – from preclinical through clinical development – with the creation and use of mathematical models that simulate disease physiology, drug action, patient variability, and trial outcomes. To address the full spectrum of related issues, Rosa offers two customized approaches: classic pharmacokinetic/ End
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