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February 02, 2010
The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.
February 01, 2010
The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
References for the article published in the February issue of Pharmaceutical Technology Europe.
October 13, 2009
Reading PharmTech's October article on Critical Challenges to Implementing QbD gave me the impression that we might have the road map to Moksha or Nirvana. Unfortunately that was not meant to be.
October 02, 2009
The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.
Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.
The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.
Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.
A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.
The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.