Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 43, Issue 4, Pages 1297-1305Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.jpba.2006.10.037
Keywords
real time release; near-infrared; process models; chemometrics; process analytical technology; Multivariate statistical process control; regression; models; tablet manufacturing
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Real time release (RTR) of products is a new paradigm in the pharmaceutical industry. An RTR system assures that when the last manufacturing step is passed all the final release criteria are met. Various types of models can be used within the RTR framework. For each RTR system, the monitoring capability, control capability and RTR capability need to be tested. This paper presents some practical examples within the RTR framework using near-infrared and process data obtained from a tablet manufacturing process. (c) 2006 Elsevier B.V. All rights reserved.
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