Scientific Issues in Botanical Drug Product Development

In recent years, as more and more innovative drug products are going off patents, the search for new medicines such as botanical drug products that can treat critical and/or life-threatening diseases has become the center of attention of many pharmaceutical companies and research organizations such as the United States National Institutes of Health (NIH). A botanical drug product is often recognized as a traditional Chinese (herbal) medicine (TCM). The use of TCM in humans for treating various diseases has a history of a few thousand years, although not much convincing scientific evidence (documentations) regarding clinical safety and efficacy are available. Thus, how to effectively and scientifically develop a promising TCM the Western way has become an important issue in public health. The purpose of this article is to provide a comprehensive overview regarding scientific and/or regulatory issues that are commonly encountered in botanical drug product or TCM development. These issues include, but are not limited to, intellectual property (IP), variation (or consistency) in raw materials, component-to-component interactions, animal studies, matching placebo and calibration of study endpoints in clinical trials, packaging insert, and transition from experience-base to evidence-base clinical practice.