645 Materials Characterization

Thursday, November 1, 2012: 8:30 AM
Allegheny II (Westin )
Description:
Materials Characterization plays a critical role in QbD Pharmaceutical Process Development. A firm understanding of the properties of API and /or drug product intermediates can facilitate design of robust processes that consistently produce drug product with the desired quality attributes. Presentations that show the integration materials characterization into QbD drug product development are requested for this session.

Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Chair:
Robert E. Yule
Email: robert.e.yule@gsk.com

Co-Chair:
Shekhar Viswanath
Email: VISWANATH_SHEKHAR@LILLY.COM

- indicates paper has an Extended Abstract file available on CD.

File available
8:30 AM
(645a) Quantitative Characterization of Powder Flow Under Dynamic Conditions in a Rotating Drum
John F Miller

8:55 AM
(645b) Impact of Formulation Properties On Lubrication of Common Tableting Excipients
Benjamin J. Baranowski and Joseph Kushner IV

9:20 AM
(645c) Formulation Development of Hot Melt Extrudate to Stabilize Amorphous API
Sandeep B. Kedia

9:45 AM
(645d) Agglomerate Characterization in Pharmaceutical Systems
Dushyant Shekhawat

10:10 AM
(645e) Development of API Target Attribute Profile
Weili Yu and Subodh Deshmukh

10:35 AM
(645f) Application of Materials Science Approaches to Facilitate Drug Substance and Product Processing
Thomas Borchardt and Raimundo Ho
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
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