2010 Annual Meeting

Session: TI Application of Quality by Design in Drug Product Process Development

Quality-by-Design (Qbd), formally defined in ICH Q8(R1) Pharmaceutical Development, involves understanding the relationship between the manufacturing process and the drug product quality attributes. It requires defining a "design space" for the range of material or process inputs that will yield a product with acceptable attributes. Speakers are invited to present first-principles, experimental, or semi-empirical methods used to develop design spaces during drug product development. Speakers are also invited to discuss methods and case studies using risk assessment to determine what variables do and do not need to be included in design spaces.

Chair

Kevin J. Bittorf, Vertex Pharmaceuticals

Co-Chair

John C. Strong, Abbott Laboratories

Presentations

08:30 AM

08:50 AM

Indra Neil Mukherjee, Neil MacPhail, Catherine Diimmler, Mitchell Colletto, Eric Seymour

09:10 AM

09:30 AM

09:50 AM

James N. Michaels, Holly Bonsignore, Buffy L. Hudson-Curtis, Steven Laurenz, Thomas Mathai, Girish Pande, Ashlesh Sheth, Omar Sprockel, Homer Lin

10:10 AM

Sarina G. Harris Ma, Derrick Kim, Chen Mao, Laura Maurer, Sami Karaborni