Session: Qbd Across Drug Product Operations (2009 Annual Meeting)

Description:

This session focuses on work where multiple steps in the drug product operation are considered simultaneously in a Design Space. Authors are invited to discuss the physical circumstance (how and why the multiple steps are linked) and the tools they used to quantify, visualize and define the design space

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:

Mary T. Am Ende
Associate Research Fellow
Pfizer
Oral Products Center of Emphasis
Eastern Point Road
Groton, CT 06340
Phone Number: 860-441-4210
Fax Number: 860-686-5404
Email: mary.t.am.ende@pfizer.com

Co-Chair:

John Strong

Papers:

166a

Design Space Continuum: From Drug Substance to Drug Product
T. Kourti, GlaxoSmithKline and McMaster University

166b

Implementing Risk- and Knowledge Management Tools Into Product- and Process Development According to Quality by Design
Brigitte Guebitz, Research Center Pharmaceutical Engineering GmbH; Johannes Fritz, THE LIFECYCLE INTELLIGENCE GROUP GmbH; Hubert Schnedl, THE LIFECYCLE INTELLIGENCE GROUP GmbH; Siegfried Adam, Research Center Pharmaceutical Engineering GmbH; Stefan Radl, Research Center Pharmaceutical Engineering GmbH; Johannes Khinast, Graz University of Technology

166c

Application of QbD Principles to Analytical Methods
Kimber Rundlett, Pfizer Global Research & Development

166d

The Development of Methods to Link Design Space Models to Product Stability
Zhixin Zong, The University of Iowa; Peter L. Wildfong, Duquesne University; Lee E. Kirsch, The University of Iowa; Aditya M. Kaushal, University of Minnesota; Eric J. Munson, University of Kansas; Raj Suryanarayanan, University of Minnesota; Dewey H. Barich, University of Kansas; Kalyana Pingali, Rutgers University; Fernando J. Muzzio, Rutgers University; Defne Kayrak-Talay, Purdue University; Salil D. Desai, The University of Iowa; Ira Shea Buckner, Duquesne University

166e

Establishing Appropriate Particle Size Specifications for Solid Oral Dosage Forms
Zhigang Sun, Office of Generic Drugs, OPS, CDER, FDA

166f

Using QbD Approaches to Enable Development of Real Time Release for a Continuous Drug Product Process
David C. A. Sharp, Pfizer Global Manufacturing

166g

Multivariate Texture and Image Analysis for Solid Dosage Intermediate and Final Product Characterization and Downstream Performance Prediction
Salvador Garcia-Munoz, Pfizer Global Research and Development; Alan Carmody, Pfizer Global Research and Development

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

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