04 October 2011
New methods are needed to characterize FPM in drug manufacturing. In this article, Julianne Wolfe, Karen Smith, and Linxian Wu of RJ Lee Group propose a system to extend Quality by Design (QbD) methodology to this critically important area of pharmaceutical quality control.
Posted in Expert Insights, Resources0 Comments
26 September 2011
QbD’s success depends on rapid knowledge generation, which has its roots in multivariate modeling, says AIChE award recipient Jose Tabora.
Posted in Expert Insights, QbD News0 Comments
13 September 2011
The emphasis behind QbD must evolve into a business proposition: one that resonates with the generics industry as a foundation for competitiveness, argues Pharmatech’s Bikash Chatterjee.
Posted in Expert Insights, Opinion Editorial0 Comments
07 September 2011
One of the architects of QbD has decided to leave the Agency after 22 years.
Posted in QbD News0 Comments
06 September 2011
A two-part series in American Pharmaceutical Review examines how QbD can impact risk and cost in freeze-thaw processes, and provides case studies based upon applications using different storage containers.
Posted in Readers' Choice, Resources0 Comments
25 August 2011
Mark your calendars. This show has become a favorite of the PAT and QbD crowd.
Posted in QbD News0 Comments
Added on 13 December 2010
zasmine: This is agreat article AMS!
Thank you for the int...
WelchEthel23: Set your life easier get the ...
epcotint: McKinsey report points to different challenges com...
malcolm ross: I was delighted to see the title of this article-b...
epcotint: Process validation is being thrust on the industry...
