Application of Quality by Design in Drug Product Formulation Design & Process Development
AIChE Annual Meeting
2015
2015 AIChE Annual Meeting Proceedings
Pharmaceutical Discovery, Development and Manufacturing Forum
Oral
Ballroom B
Salt Palace Convention Center
Monday, November 9, 2015 - 3:15pm to 5:45pm
Chair(s)
Co-chair(s)
Pharmaceutical Quality by design (QbD) is a systematic, risk-based, scientific approach for product design and process development to ensure predefined drug product quality. It requires a thorough understanding of critical formulation attributes and critical process parameters as well as impacts of their variations on the final drug product quality. The goals of implementing pharmaceutical QbD are to reduce product variability and defects, maximize safety and efficacy for the patient, increase product development and manufacturing efficiencies, and enhance post-approval change management. This session invites presentations to demonstrate the application of QbD principles during formulation design and process development of a drug product. Papers concerning small and large molecules, including biologics, are being considered. It is intended to provide an open forum to explore how to facilitate QbD implementation in pharmaceutical industry.
Papers
Checkout
Paper abstracts are public but to access Extended Abstracts, you must first purchase the conference proceedings.
Do you already own this?
Log In for instructions on accessing this content.
Pricing
Individuals
2015 AIChE Annual Meeting Proceedings
AIChE Members | $150.00 |
AIChE Graduate Student Members | Free |
AIChE Undergraduate Student Members | Free |
Non-Members | $225.00 |
Pharmaceutical Discovery, Development and Manufacturing Forum only
AIChE Members | $100.00 |
AIChE Food, Pharmaceutical & Bioengineering Division Members | Free |
AIChE Graduate Student Members | Free |
AIChE Undergraduate Student Members | Free |
Non-Members | $150.00 |