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Activity Number: 501
Type: Contributed
Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #311474
Title: Using a Tolerance Region Approach as a Statistical Quality Control Process for Traditional Chinese Medicine
Author(s): Chinfu Hsiao*+ and Yi-Hsuan Lai
Companies: National Health Research Institutes and National Health Research Institutes
Keywords: quality control ; Traditional Chinese Medicine ; Tolerance Region
Abstract:

A statistical quality control (QC) process for raw materials and/or the final product of traditional Chinese medicine (TCM) is proposed based on a tolerance region. We construct a tolerance region for a multivariate random effects model to assess the quality control of TCM products from different regions and different batches. The product is then declared to pass the QC only if the constructed region is within the permitted range. An example concerning the development of a TCM for treating patients with rheumatoid arthritis is used to illustrate the proposed approach based on the tolerance region for QC.


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