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Publications
Proceedings
2011 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
QbD for Modified Release Dosage Forms
2011 Annual Meeting
Session: QbD for Modified Release Dosage Forms
Chair
Zhigang Sun
, Office of Generic Drugs, OPS, CDER, FDA
Co-Chair
Mary T. Am Ende
, Pfizer Global Manufacturing
Presentations
03:15 PM
(607a) CMC Reviewer Expectations for ANDAs Using QbD Approaches
Robert L. Iser
03:35 PM
(607b) Mechanistic Models and Computer Software for Quality by Design In Formulation of Modified Release Dosage Forms
Xiao Yu Wu, Yousheng Zhou
03:55 PM
(607c) Mechanistic Investigation of Drug Release From Asymmetric Membrane Tablets
04:15 PM
(607d) QbD for Generic MR Drug Products
Yue (Helen) Teng
04:35 PM
(607e) Fluid Bed Coating Process for Modified Release Applications
Orapin Rubino
04:55 PM
(607f) Implementation of QbD In the Development of a CR Dosage Form
Nancy E. Sever, Michael Brian Mackaplow, Didier LeFebvre
05:15 PM
(607g) Control Strategy for Manufacturing of Modified Release Capsules: A Regulatory Perspective
Zhigang Sun