FDA has recently issued a nonbinding draft guidance aimed at applying the science-based principles of Quality by Design to transdermal and similar delivery devices. The ultimate goal is to minimize the amount of residual drug product left in skin patches and other transdermal and transmucosal delivery systems.

 Read more...

Fall means conference season, and QbD-oriented events abound worldwide. Here’s a look at some of the more noteworthy, kicked off by a video promo for an upcoming webinar on QbD for freeze-dried parenterals. A tip of the cap to Baxter BioPharma Solutions’ Lisa Hardwick and Steve Nail for facing the camera to promote their event.

 Read more...

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.

 Read more...

By Paul Thomas, Senior Editor

“I’m a bench scientist,” says Dan Rudmann, DVM, PhD, Group Leader, Pathology and Imaging for Lilly Research Laboratories. But he’s also a certified Lean Six Sigma Black Belt, and people often ask Rudmann why he would choose to be both. Where are the synergies?

 Read more...

By Emil Ciurczak, Contributing Editor

A week or so ago, I had the pleasant experience of a week in Central Finland. Other than I consider Finland one of the most beautiful countries in the world, the scientific stimulation was well worth the trip.
Whilst the primary reason I went was to participate in EuPAT 4 (sponsored by the European Federation for Pharmaceutical Sciences), I also had the opportunity to participate in a one-day graduate course at the University of East Finland (formerly University of Kuopio, plus two other universities).

 Read more...

By Agnes Shanley

Anyone looking for hopeful signs of change in the ongoing industry/FDA impasse on smart manufacturing–specifically, PAT and QbD–was bound to be disappointed by this week’s FDA “Partnering with Industry” meeting in Bethesda.

 Read more...