Statistical quality control process for traditional Chinese medicine

Research output: Journal Publications and Reviews (RGC: 21, 22, 62)21_Publication in refereed journalpeer-review

18 Scopus Citations
View graph of relations

Author(s)

  • Jang-Yang Chang
  • Wei-Lun Su
  • Shein-Chung Chow
  • Chao Hsiung
  • Qingshu Lu

Related Research Unit(s)

Detail(s)

Original languageEnglish
Pages (from-to)861-874
Journal / PublicationJournal of Biopharmaceutical Statistics
Volume16
Issue number6
Publication statusPublished - 1 Dec 2006

Abstract

The statistical quality control process on raw materials and/or the final product of traditional Chinese medicine (TCM) is examined. We develop a statistical quality control (QC) method to assess a proposed consistency index of raw materials from different sources and/or final products manufactured at different sites. The idea is to construct a 95% confidence interval for a proposed consistency index under a sampling plan. If the constructed 95% confidence lower limit is greater than a prespecified QC lower limit, then we claim that the raw material or final products have passed the QC and hence can be released for further processing or use; otherwise, the raw materials and/or final product should be rejected. For a given component (the most active component if possible), a sampling plan is derived to ensure that there is a desired probability for establishing consistency between sites when there is truly no difference in raw materials or final products between sites. An example concerning the development of a TCM is presented to illustrate the proposed statistical QC method for assessing consistency in raw materials from two sites. Copyright © Taylor & Francis Group, LLC.

Research Area(s)

  • Acceptance criteria, Consistency index, Sampling plan, Test procedure

Citation Format(s)

Statistical quality control process for traditional Chinese medicine. / Tse, Siu-Keung; Chang, Jang-Yang; Su, Wei-Lun; Chow, Shein-Chung; Hsiung, Chao; Lu, Qingshu.

In: Journal of Biopharmaceutical Statistics, Vol. 16, No. 6, 01.12.2006, p. 861-874.

Research output: Journal Publications and Reviews (RGC: 21, 22, 62)21_Publication in refereed journalpeer-review