TI Application of Quality by Design in Drug Product Process Development
AIChE Annual Meeting
2010
2010 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Oral
Grand Ballroom B
Salt Palace Convention Center
Thursday, November 11, 2010 - 8:30am to 11:00am
Chair(s)
Co-chair(s)
Quality-by-Design (Qbd), formally defined in ICH Q8(R1) Pharmaceutical Development, involves understanding the relationship between the manufacturing process and the drug product quality attributes. It requires defining a "design space" for the range of material or process inputs that will yield a product with acceptable attributes. Speakers are invited to present first-principles, experimental, or semi-empirical methods used to develop design spaces during drug product development. Speakers are also invited to discuss methods and case studies using risk assessment to determine what variables do and do not need to be included in design spaces.
Presentations
Topics
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Pricing
Individuals
2010 Annual Meeting
AIChE Pro Members | $150.00 |
AIChE Graduate Student Members | Free |
AIChE Undergraduate Student Members | Free |
AIChE Explorer Members | $225.00 |
Non-Members | $225.00 |
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
AIChE Pro Members | $100.00 |
Food, Pharmaceutical & Bioengineering Division Members | Free |
AIChE Graduate Student Members | Free |
AIChE Undergraduate Student Members | Free |
AIChE Explorer Members | $150.00 |
Non-Members | $150.00 |