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W 18: Quality Consistency Assessment for Botanical Medicines using Chromatographic Fingerprint





Poster Presenter

      Cassie Dong

      • Mathematical Statistician, Division of Biometrics VI, OTS, CDER
      • FDA
        United States

Objectives

To have an overview of the current issues regarding the quality control of botanical products; to understand some bacis statistical methods applied to batch consistency assessment for botanical products;

Method

Our work provides a comprehensive review on current statistical models in fingerprints similarity assessment from IND/NDA submissions and literatures for botancial products. We also develop a more sensitive analysis to assess batch consistency

Results

, we will provide a comprehensive review on current statistical models in fingerprints similarity assessment from IND/NDA submissions and literatures. Advantages and disadvantages of each method and potential review issues will be presented. Second, we will study two potential similarity measurements, which are the correlation index and the chi-square type index, to quantitatively evaluate the similarity in fingerprints. In order to adjust for the natural variability within the same products, we also propose to divide the correlation or the chi-square difference by the measure of fingerprints of two reference batches. Such measurements are called ratio of correlations and ratio of chi-squares. Simulation studies to compare our proposed model with existing models will be conducted and discussed. We will also illustrate our model through real-data example. Results of this project can facilitate IND and NDA reviews in quality control of botanical medicines by providing evidence-based method.

Conclusion

the current approaches have their limitations to assure the quality consistency for botanical product. A more advanced approach is needed.