2009 Annual Meeting

Session: Qbd Across Drug Product Operations

Chair

Mary T. Am Ende, Pfizer Global Manufacturing

Co-Chair

John C. Strong, Abbott Laboratories

Presentations

03:15 PM

(166a) Design Space Continuum: From Drug Substance to Drug Product
T. Kourti

03:35 PM

(166b) Implementing Risk- and Knowledge Management Tools Into Product- and Process Development According to Quality by Design
Brigitte Guebitz, Siegfried Adam, Hubert Schnedl, Johannes Fritz, Johannes Khinast

03:55 PM

(166c) Application of QbD Principles to Analytical Methods
Kimber Barnett

04:15 PM

(166d) The Development of Methods to Link Design Space Models to Product Stability
Zhixin Zong, Peter L. Wildfong, Raj Suryanarayanan, Eric J. Munson, Aditya M. Kaushal, Dewey H. Barich, Kalyana Pingali, Fernando J. Muzzio, Defne Kayrak-Talay, Salil D. Desai, Ira Shea Buckner

04:35 PM

(166e) Establishing Appropriate Particle Size Specifications for Solid Oral Dosage Forms
Zhigang Sun

04:55 PM

(166f) Using QbD Approaches to Enable Development of Real Time Release for a Continuous Drug Product Process
David C. A. Sharp

05:15 PM

(166g) Multivariate Texture and Image Analysis for Solid Dosage Intermediate and Final Product Characterization and Downstream Performance Prediction
Salvador Garcia-Munoz, Alan Carmody