Session: Applications of Multivariate Data Analysis in Pharmaceutical Process Development (2010 Annual Meeting)

Description:

The quality by design paradigm has rapidly increased the adoption of multivariate data analysis in Pharmaceutical Development. The application of these powerful techniques on experimental, process, or PAT data can result in significant increases of development productivity and substantial reduction of process risk. Authors are encouraged to submit papers discussing case studies in which multivariate data analysis was applied to increase process understanding to improve process robustness and performance or decrease development time.

Sponsor:

Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Co-Sponsor(s):

Pharmaceuticals (15b)

Chair:

Sze Wing Wong
Research Scientist
Eli Lilly and Company
Chemical Product Research and Development
Lilly Corporation Center
Indanapolis, IN 46285
Phone Number: 317-276-0015
Email: wongsz@lilly.com

Co-Chair:

Jose E. Tabora
Senior Principal Scientist
Bristol-Myers Squibb
Research and Development
One Squibb Drive
New Brunswick, NJ 08901
Phone Number: 732-227-5099
Email: jose.tabora@bms.com

Papers:

445a

Optimal Material Selection for Oral Dosage Development and Manufacture Using Optimization Techniques and Multivariate Latent Variable Models
Salvador Garcia-Munoz, Pfizer Inc.; Jose Mercado, Pfizer Inc.; Israel Cotto, Pfizer Inc.; Victor Ruiz, Pfizer Inc.; Ivelisse Colon-Rivera, Pfizer Inc.; Denise Rivkees, Pfizer Inc.; Josh Shockey, Greenridge Consulting; Matt Shaffer, Greenridge Consulting; Leah Appel, Greenridge Consulting

445b

Applications of Genetic Algorithms for Variable Selection in Pharmaceutical Development
Jose E. Tabora, Bristol-Myers Squibb Company; Jacob Albrecht, Bristol-Myers Squibb Company; James Bergum, Bristol-Myers Squibb Company; Amanda Rogers, Bristol-Myers Squibb Company; Victor Rosso, Bristol-Myers Squibb Company

445c

Multivariate Analysis of Historical Process Data for Monitoring, Control and Scale-up
Samarth Rathore, Eli Lilly; David Reed, Eli Lilly; Marc Champagne, Eli Lilly

Break

445d

Estimation of Active Pharmaceutical Ingredients Content In Blending Process for Drug Products Manufacturing
Sanghong Kim, Kyoto　University; Hiroshi Nakagawa, Daiichi Sankyo Co., Ltd.; Manabu Kano, Kyoto　University; Shinji Hasebe, Kyoto　University

445e

Desensitizing near-Infrared Calibration Models for Physical Interferences in Tablets During Formulation/Process Development
Benoit Igne, Duquesne University; Zhenqi Shi, Duquesne University; Carl A. Anderson, Duquesne University; James K. Drennen III, Duquesne University

445f

Imaging Pharmaceutical Fluidised Bed Multi-Processes with Electrical Capacitance Tomography
Haigang Wang, Institute of Thermophysics Engineering; Lubomir Gradinarsky, AstraZeneca R&D Mölndal; Staffan Folestad, AstraZeneca R&D Mölndal; Proctor Ian, The University of Manchester; Wuqiang Yang, The University of Manchester

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

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