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Publications
Proceedings
CCPS 17th Annual International Conference and Workshop Risk, Reliability, and Security
General Submissions
TECHNICAL PAPERS
Selective Catalytic Reduction (SCR) System Design and Operations: Quantitative Risk Analysis of Options
2011 Annual Meeting
Session: QbD for Modified Release Dosage Forms
Chair
Sun, Z.
, Office of Generic Drugs, OPS, CDER, FDA
Co-Chair
Am Ende, M. T.
, Pfizer Global Manufacturing
Presentations
03:15 PM
(607a) CMC Reviewer Expectations for ANDAs Using QbD Approaches
03:35 PM
(607b) Mechanistic Models and Computer Software for Quality by Design In Formulation of Modified Release Dosage Forms
03:55 PM
(607c) Mechanistic Investigation of Drug Release From Asymmetric Membrane Tablets
04:15 PM
(607d) QbD for Generic MR Drug Products
04:35 PM
(607e) Fluid Bed Coating Process for Modified Release Applications
04:55 PM
(607f) Implementation of QbD In the Development of a CR Dosage Form
05:15 PM
(607g) Control Strategy for Manufacturing of Modified Release Capsules: A Regulatory Perspective
