Assessing the consistency of traditional Chinese medicine with multiple correlative active components.

The problem of controlling the quality of raw materials and/or final product of traditional Chinese medicine (TCM) has been studied. Earlier proposed consistency index to assess the consistency of quality of raw materials and/or final product processed or manufactured from different locations or sites has only focused on a single (i.e., the most active) component assuming that the most active component can be quantitatively identified among multiple active components. In this paper, we extend such results to the case of two correlative components. Sampling plans (sample sizes) are obtained for various combinations of study parameters. An example concerning a TCM for treating patients with rheumatoid arthritis is presented to illustrate the use of the proposed method. Some concluding remarks are also provided.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics