Similarity Assessment of Chromatographic Fingerprint of Botanical Products

• Activity Number: 260
• Type: Contributed
• Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Xiaoyu Dong* and Yi Tsong and Zhuang Miao and Jinhui Dou
• Companies: FDA and FDA and FDA and FDA
• Keywords: Similarity Assessment ; fingerprinting ; hypothesis testing ; similarity index

Abstract

Botanical based herbal medicines have been used for primary health care for thousand years across many countries. Over the past decades, there has been an increasing interest in establishing botanical products as different categories of globally-acceptable products for public health. However, unlike conventional drugs which usually consist of only one or a few chemicalcomponents, botanical products, such as botanical drugs and dietary supplements, are usually mixtures of many complex phytochemicals which are difficult to be fully identified or quantified. In addition, batch-to-batch variation may arise and contribute to the heterogeneity of finished product due to the variation in climatic conditions, raw material sources, manufacturing processes, among other things. The chromatographic fingerprinting is commonly used to assess the quality of botanical products and determine the similarity of the same botanical products, with the area under each peak or the peak height as important outputs. To assess the similarity of botanical products, we investigate the existing statistical methods in this area including similarity index, hypothesis testing, PAC and weighted approaches.