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March 02, 2014
Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.
February 18, 2014
Thirteen companies are accepted for participation in the supply chain program.
February 01, 2014
Traditional project decision-making is compared with a QbD approach.
January 15, 2014
A survey of BioPharm International readers found that single-use systems and other technologies are driving process efficiencies in biomanufacturing, but there is room for improvement.
December 04, 2013
PharmaCheck, a portable tool designed to detect poor-quality medicines, has been selected by Scientific American as one of the magazine?s World Changing Ideas of 2013.
December 02, 2013
Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.
November 08, 2013
Breakthrough Therapies Raise Manufacturing Issues
November 04, 2013
EMA and FDA publish joint QbD guidance on design space verification.
November 02, 2013
Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.
October 23, 2013
The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs.
