2011 Annual Meeting

Session: Application of Quality by Design In Drug Product Process Development II

Co-Chair

Johannes G. Khinast, Research Center Pharmaceutical Engineering GmbH

Presentations

03:15 PM

(138a) Linkage of Critical Quality Attributes Across a Multi-Unit Operation Process Train Using a High-Shear Wet Granulation Design of Experiment
Diana S. Hou, Julianne Farabaugh, Gina Thompson, David Lavrich

03:35 PM

(138b) An Integrated Quality by Design (QbD) Approach towards Prediction of Protein Degradation In Heated Mixing Vessels by Computational Fluid Dynamics
Siegfried Adam, Marco Iannuccelli, Daniele Suzzi, Johannes G. Khinast

03:55 PM

(138c) Applications (and Challenges) of Utilizing QbD, DOE and Other Process Tools In the Transfer of a Sterile Lyophilized Product From One Site to Another - Practical Perspectives
Daniel Kim, Manish Sharma, David Unger, Stelios Tsinontides

04:15 PM

(138d) Dissolution of Disintegrating Solid Dosage Forms In a Modified Dissolution Testing Apparatus 2
Piero M. Armenante, Shrutiben R. Parekh

04:35 PM

(138e) QbD – More Than Just An Acronym
Sean E. Mackey

04:55 PM

(138f) Rethinking Assessment of Raw Material Variability In Drug Product Development Experiments
Stephen L. Conway

05:15 PM

Implementing Quality by Design in Pharmaceutical Salt Selection
Gregory Stephenson