| Welcoming Remarks |
An Integrated Quality by Design Qbd Approach for Pharmaceutical Powder Blending Unit Operation: Process Monitoring, Endpoint Determination, and Concentration Quantification
Huiquan Wu, CDER, FDA, 10903 New Hampshire Ave, White Oak LS 64, Room 1080, HFD-940, Silver Spring, MD 20993, Mobin Tawakkul, CDER, FDA, 10903 New Hampshire Ave, White Oak LS 64, Room 1026, HFD-940, Silver Spring, MD 20993 and Mansoor A. Khan, CDER, FDA, 10903 New Hampshire Ave, White Oak LS 64, Room 1070, HFD-940, Silver Spring, MD 20993 |
Quality By Design Using An Integrated Active Pharmaceutical Ingredient-Drug Product Approach To Development
Mary T. am Ende, Oral Products Center of Emphasis, Pfizer, Eastern Point Road, MS 8156-01, Groton, CT 06340, Vincent E. McCurdy, RFT Program Office, Pfizer, Eastern Point Road, Groton, CT 06340, Thomas P. Garcia, Regulatory CMC, Pfizer, Eastern Point Road, Groton, CT 06340, Frank Busch, Process R&D, Pfizer, Eastern Point Road, Groton, CT 06340 and Mark R. Berry, Non-Clinical Statistics, Pfizer, Eastern Point Road, Groton, CT 06340 |
The Use Of Routine Process Capability In The Determination Of Proven Acceptable Ranges (Pars) Critical Process Parameters (Cpps) And Mapping Of The Design Space For An Api Process
Kevin D. Seibert, Chermical Product Research and Development, Eli Lilly & Co., 1400 W. Raymond St., Indianapolis, IN 46221, Shanthi Sethuraman, MS&T Statistics, Eli Lilly & Co., 1400 W. Raymond St., Indianapolis, IN 46221 and Chad Wolfe, CPR&D, Eli Lilly & Co., 1400 W. Raymond St., Indianapolis, IN 46221 |
Mathematical Modeling Of The Impact Of Raw Material Variabilities On Granule Particle Size Distribution During Fluidized Bed Granulation
Pavol Rajniak, Ecevit Bilgili and Rey Chern, Merck & Co, Inc., WP78-110, PO Box 4, West Point, PA 19486 |
Synchronized Approach to Developing Optimal Control and Design Spaces
Jerry D. Mitchell1, Bernard McGarvey2, Kumar Abhinava2, Kevin Seibert2, Shanthi Sethuraman2 and Kristi Griffiths2, (1)Engineering Tech Center, Eli Lilly & Company, Indianapolis, IN 46285, (2)Eli Lilly & Company, Indianapolis, IN 46285 |
Correlation between Excipient Characteristics and Product Properties through Numerical Simulations of Tablet Compaction
Athanas A. Koynov, Rutgers University, 98 Brett Rd., Piscataway, NJ 08854 and Alberto Cuitino, Mechanical Engineering, Rutgers University, 98 Brett Rd., Piscataway, NJ 08854 |
Characterizing the Influence of Raw Material and Process Variation on Product Quality and Yields
Chris McCready, Process Analytical Technology, Umetrics Inc., 17 Kiel Ave, Kinnelon, NJ 07045 |
| Panel Discussion |
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