Session: Model Based Qbd in Drug Product (2009 Annual Meeting)

Description:

This session focuses on the use of mathematical models and simulation in establishing a Design Space in support of QbD for a Drug Product Operation. Authors are invited to share the challenges in the model development and validation, and the strategy used for QbD

Sponsor:

Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products

Co-Sponsor(s):

Systems and Process Design (10a), Process Development Division (12), Pharmaceuticals (15b)

Chair:

Fernando. J Muzzio
Rutgers University
Department of Chemical and Biochemical Engineering
98 Brett Road
Piscataway, NJ 08854
Phone Number: 732-445-3357
Email: fjmuzzio@yahoo.com

Co-Chair:

Nancy E. Sever

Papers:

465a

Correlation of Material Properties and Process Parameters to Pharmaceutical Tablet Mechanical Characteristics Using a Quai-Continuum Model
Athanas A. Koynov, Rutgers University; Alberto Cuitino, Rutgers University

465b

Flowchart Methodology Utilizing Validated Process Models as the Foundation for a Quality-by-Design (QbD)-Based Approach for Pharmaceutical Unit Operations: Example Case Studies
Lisa J. Graham, Bend Research, Inc.; Daniel E. Dobry, Bend Research, Inc.; Ronald A. Beyerinck, Bend Research, Inc.

465c

Model Based Approach to Determine Optimum Operating Conditions in High Shear Granulation
Defne Kayrak-Talay, Purdue University; James D. Litster, Purdue University; James K. Drennen III, Duquesne University

465d

Modeling Density and Temperature Distributions in Powder Die Compacts
Jerry R. Klinzing, Drexel University; Antonios Zavaliangos, Drexel University; John Cunningham, Johnson & Johnson Pharmaceutical Research & Development; Tracey Mascaro, Johnson & Johnson Pharmaceutical Research & Development; Denita Winstead, Johnson & Johnson Pharmaceutical Research & Development

465e

Film Coating End-Point Determination for Colored Immediate Release Tablets Using Multivariate Image Analysis
Salvador Garcia-Munoz, Pfizer Global Research and Development; Daniel Gierer, Pfizer Global Research and Development

465f

The Effect of Tablet Shape On Film Coating Uniformity Using the Discrete Element Method
William R. Ketterhagen, Pfizer Inc.

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

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