Botanical Drug Product Development: Scientific Issues

Authored by: Annpey Pong , Shein-Chung Chow

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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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 entry is to provide an overview of 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.

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