Whether you’re bound for the beach, the mountains, or the office, why not take along some summer reading? We’ve compiled a list of some of the more noteworthy QbD-related articles and items to be published this summer from various sources. Upload them to your laptop, or print them and put them in your suitcase. And let us know if you have QbD reading suggestions as well.

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By Paul Thomas, Senior Editor

Simulation and modeling are a cornerstone of comprehensive Quality by Design programs, and yet the tools to do the type of modeling that drug developers need are a work in progress.

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By Paul Thomas, Senior Editor

Pfizer’s Gerald Migliaccio, Senior VP of Network Unit Performance, is an unabashed advocate for Quality by Design, and in a June 16 talk at DIA 2010 in Washington, DC, Migliaccio defended QbD against those who would say it is “too expensive” to implement. (This is a common refrain, particularly amongst smaller manufacturers who say “We’re not Pfizer” and don’t have the resources for QbD.) Migliaccio used ROI-related data from his own company’s work to emphasize QbD’s worth.

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By John Avellanet, Cerulean Associations, LLC

Editor’s Note: The following is excerpted with author’s permission from “Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine.” Publication details are at the bottom of this page.

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By Jason Kamm, Tunnell Consulting, Inc.

ICH (the International Conference on Harmonization, www.ich.org) Q8 and the Quality by Design (QbD) guidance issued by the FDA offer pharmaceutical manufacturers a significant opportunity to design quality into their manufacturing processes instead of inspecting it in after the fact. Companies that take advantage of Q8 report seeing fewer deviations and rejected batches, reducing risk and easing regulatory compliance burdens, while achieving continuous improvement. The key to achieving QbD is to successively map and master three “spaces”:

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